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Intervention to Improve Quality of Life in African American Lupus Patients
The goal of the proposed project is to enhance the Principal Investigator's research ability to conduct behavioral interventions for people with lupus. This includes intervention design, implementation, data collection and data analysis. The Intervention to Improve Quality of life for African-AmericaN lupus patients (IQAN) Project is designed to examine whether a uniquely tailored intervention program can improve quality of life, decrease indicators of depression, and reduce perceived and biological indicators of stress in African American lupus patients. This study builds on three decades of work conducted in the field of arthritis self-management but differs in that the intervention mode, the disease (lupus), and the study population (African-Americans) are unstudied or understudied. The IQAN Project will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model as its theoretical framework. This program has three specific aims. The first aim seeks to design a three armed randomized, wait list controlled trial that employs a patient-centered 'a-la-carte' approach that offers subjects a variety of modes of interaction, allowing them to choose as many or few as they wish. The second aim is to assess the intervention, using the RE-AIM model framework. The third aim, to be achieved before the first aim, is to use previously collected data to characterize patient-centric barriers to care in African-American lupus patients, in order to identify trends in patient needs and desires, as well as correlates of non-response and non-compliance that can be used in the development and refinement of the intervention.
Preventive Approach to Congenital Heart Block With Hydroxychloroquine
This Phase II study will evaluate for the first time whether hydroxychloroquine, a drug used by many patients with SLE, prevents the development of a heart condition called congenital heart block in the fetus. This heart problem is thought to be caused by autoantibodies some women with lupus produce to proteins called SSA/Ro and or SSB/La. The heart beats abnormally slowly and almost all children require permanent pacemakers before the age of 20. Importantly, women who have had one child with heart block have a ten-fold higher risk of having another child with the same heart condition. Unfortunately, even close monitoring by special techniques during pregnancy does not reverse complete heart block once it is observed. Thus, treatments aimed at prevention are critical. Data from laboratory experiments suggests that this drug, which crosses the placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to the fetus. The study plans to enroll 19 patients in the first year. Patients can already be on hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that less than 3 cases of heart block will occur. The results of this study are expected to become an integral part of the counseling of women with anti-Ro/La antibodies who are considering pregnancy. The trial is sponsored by New York University School of Medicine.
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
The purpose of this Phase 2 study is to evaluate the efficacy and safety of the investigational treatment, MEDI-546, compared to placebo among patients with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) who have not responded sufficiently to standard of care treatment for their disease. To participate, patients must be 18 to 75 years of age and meet other medical criteria. The one-year study is sponsored by MedImmune LLC.
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
The Phase 2 trial aims to determine a safe daily dosage for lupus patients to take N-acetylcysteine (NAC) widely available in health food stores in combination with other treatments. Existing data in the literature provide evidence that a natural antioxidant, glutathione, is depleted in T cells of patients with SLE and may be a key factor behind abnormal cell death. NAC seems to lead to the production of glutathione. Administration of NAC has been shown to increase the level of glutathione, improve the clinical outcome of lupus in mice and limit the toxicity of medications commonly used in patients with SLE. Also, in a one-year study of patients with inflammatory lung disease treated with prednisone and azathioprine, addition of NAC lessened the severity of the disease and reduced side effects compared with placebo. NAC also has been found to improve muscle fatigue. This study consists of two parts, Aim 1 (completed) and Aim 2 which is currently enrolling patients.
The purpose of Aim 1 was to establish the optimal daily oral dose of NAC that can be well tolerated without side effects and can normalize or moderate the depletion of GSH in lupus T cells. Aim 2 will determine the tolerance and impact of two NAC doses on disease activity and the use of the common corticosteroid prednisone in 165 SLE patients 18 or older in a 12-month study. The study is sponsored by the State University of New York, Upstate Medical University.
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In
Generalized Lupus Erythematosus (BUTTERLY)
The objective of this Phase 2 trial is to evaluate and compare the effectiveness of the investigational PF-04236921 at three dosages to placebo as a treatment for people with
generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. Patients must be between 18 and 75 years old and be diagnosed with systemic lupus erythematosus among other clinical criteria. Participants will be in the study for 24 weeks. The study is sponsored by the pharmaceutical company Pfizer and is being conducted at more than 25 sites throughout the United States, Hungary and Republic of Moldova.
Prospective Study of Rapamycin for the Treatment of SLE
The purpose of this Phase 2 study is to determine the effectiveness of Rapamune and how it works as a treatment for patients with SLE. Rapamycin, also called sirolimus or Rapamune, has been approved by the FDA to prevent rejection of organ transplants. Patients that were resistant or intolerant to conventional medication have been effectively treated with Rapamycin and were able to decrease the amount of the corticosteroid prednisone that they needed. Sponsored by the State University of New York, Upstate Medical University the study will lasts one year; 40 SLE patients 18 years and older and 40 healthy volunteers are being recruited. The study drug, Rapamune, is manufactured by Pfizer Pharmaceuticals.
Triptorelin for Ovary Protection in Childhood Onset Lupus
The purpose of this Phase 2 study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus lupus and to see what effects it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are between nine and 21 years of age, and require intravenous cyclophosphamide to control the disease. A total of 50 patients will participate in this study sponsored by Watson Pharmaceuticals and the U.S. Food and Drug Administration Office of Orphan Products Development. Each patient will be in the study for approximately 23 months.
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (EMBODY 1)
The primary objective of this Phase III study is to confirm the effectiveness of epratuzumab in treating patients with moderate to severe Systemic Lupus Erythematosus (SLE) after 48 weeks. Secondary objectives include evaluating response to treatment after 24 and 36 weeks as well as reductions in daily dosages of corticosteroids. To enroll patients must be 18 years or older, have moderate to severe SLE and be on a treatment regimen that includes mandatory corticosteroids and immunosuppressants or antimalarials, among other criteria. The trial lasts 48 weeks.
Epratuzumab, developed by Immunomedics and licensed to UCB for all autoimmune disease indications, is a humanized anti-CD22 monoclonal antibody with the potential to modulate B-cell activity. Although the exact role of CD22 is not fully understood, it seems to effect regulation of B cells. B cells are known to contribute to SLE by producing antibodies against the body's own cells and tissues, causing the immune system to turn on itself, resulting in inflammation and tissue damage.
Zostavax in Systemic Lupus Erythematosus
This Phase I study will look at the immune response to commercially available Zostavax (zoster vaccine live) against shingles in adult patients with SLE who have minimal disease activity and are on mild immunosuppressant medications, and to compare the immune response to that of healthy people after vaccination. The rationale for the study is that individuals with systemic lupus erythematosus (SLE, lupus) appear to be at greater risk for the development of shingles, a painful reactivation of the varicella zoster virus that causes chicken pox. All participants must be 50 or older and meet other criteria. Zostavax is marketed by Merck.
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)
This Phase 3 one-year study conducted at many centers throughout the world is evaluating the efficacy, safety and tolerability of the commercially available Benlysta (belimumab) when given to patients with active Systemic Lupus Erythematosus as a weekly injection under the skin. Currently, belimumab is given intravenously. The study will evaluate changes in scales measuring overall SLE disease activity while at the same time ensuring that the improvement is not accompanied by worsening in other ways such as organ flares. In addition, time to first severe flare and reduction in prednisone dose will be evaluated. To participate, patients can be male or female and must be at least 18 and be diagnosed with active SLE among other criteria. Mmarketed by Human Genome Sciences and Glaxo SmithKline, Benlysta is a monoclonal antibody against the B cell survival factor BAFF, also known as BLyS.
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
This 12-week observational study will observe patients with and without systemic lupus erythematosus who have persistent antiphospholipid antibodies in the blood who are starting a medicine called hydroxychloroquine. It will measure if these patients have a change in a blood test called the annexin A5 resistance assay that can detect if there is a problem with a protective shield on the surface of cells involved in abnormal blood clotting. To participate patients must be 18-65 years of age with persistent Antiphospholipid Syndrome and about to begin treatment with hydroxychloroquine. Antiphospholipid Syndrome (APS) is an autoimmune disorder of blood clotting and pregnancy loss. It is associated with proteins called antiphospholipid antibodies (aPL) in the blood. The study sponsor is Hospital for Special Surgery in New York.
A Study of LY2127399 in Patients With Systemic Lupus Erythematosus (ILLUMINATE)
This purpose of this Phase 3 multicenter study, part of the ILLUMINATE Clinical Trial Program, is to evaluate the effectiveness, safety, and tolerability of different doses of “LY2127399” in adults with active systemic lupus also taking standard therapy. The 1,140 participants that the study aims to enroll worldwide will, at various intervals over the course of a year, receive either a placebo (dummy drug) or the agent, LY2127399, by injection under the skin (subcutaneously). Factors such as number of flares, prednisone dose, and overall doctor’s assessment are also measured.
Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Arthritis
Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for the illness, multiple sclerosis. The current lupus study aims to evaluate the safety and clinical effect of daily oral treatment with the drug in capsule form in people with active lupus arthritis. The Phase II multicenter, randomized and placebo-controlled study begin in June 2010 and is projected to end in December 2011.
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (ROSE)
This Phase II, randomized, double-blind, placebo-controlled multicenter study sponsored by Genentech aims to evaluate the efficacy and safety of rontalizumab compared with placebo in people with moderately to severely active systemic lupus erythematosus (SLE). The study will enroll approximately 210 patients at up to 100 sites in North America, Latin America, and Europe.
Genetic Study of Lupus Patients and Their Families
Little is known about the genetic factors that predispose people to developing SLE. Genes in patients with SLE may provide clues about SLE's pathogenesis. This study will compare genes from SLE patients, their unaffected family members, and control participants. Travel to the study site is not required. In this study, blood samples will be collected from people diagnosed with SLE, their unaffected family members, and condition-matched controls. Participants will be asked questions about their health and will provide a small blood sample. Participants will also be asked to provide written permission for release of medical information, so that their disease status can be verified through medical record review or through consultation with their doctors. Study personnel may contact participants in the future for follow-up questions and additional blood draws, if the participant agrees.
GnRH-a for Ovarian Protection During CYC Therapy for Rheumatic Diseases (LUPRON)
The purpose of this Phase III study is to determine whether the use of the gonadotropin releasing hormone (GnRH)-agonist leuprolide acetate (Lupron) during cyclophosphamide therapy in women with rheumatic diseases (such as lupus) will provide greater ovarian protection than placebo. As a gonadotropin release hormone agonis, Lupron is a type of medication that suppresses ovulation by stopping the production of the hormones estrogen and progesterone. Cyclophosphamide is a type of drug known as a disease-modifying anti-rheumatic drug (DMARD), which dampens down the immune system. Patients will be women ages 18-40 with either a severe rheumatic disease or interstitial lung disease requiring treatment with requiring cyclophosphamide. Sponsored by the National Institutes of Health, this trial lasts six months. Approved as a treatment for several other diseases, Lupron is in development by Abbott as a possible treatment in lupus.
A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus Erythematosus
To evaluate the safety and tolerability of multiple IV doses of the MEDIMUNNE antibody in adult patients with SLE.
Estrogen and Gender Biased Autoimmunity
This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.
Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus
This study is designed to examine whether treating patients with lupus with high dose cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune system), followed by return of their previously collected stem cells will result in improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.
Health-Related Quality of Life Measure in Pediatric Lupus
Earlier studies have shown that SLE significantly impacts QOL in adults. At present, there is no disease-specific instrument for measuring HRQOL in children with SLE. In response to these concerns, we developed the "Simple Measure of Impact of Lupus Erythematosus in Youngsters© (SMILEY©).
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS) (PROMISSE)
The PROMISSE Study is a prospective observational study that will follow 700 pregnant patients who will be grouped and analyzed according to the presence or absence of aPL antibodies and preexisting SLE. The patients are followed regularly during the course of the pregnancy, collecting medical and obstetrical information as well as serial blood specimens for complement and cytokine assays. The data obtained will be analyzed and used to identify mechanisms and predictors of poor fetal outcome. We expect that the insights provided through this study will suggest means to prevent, arrest or modify these conditions.
Allogeneic Stem Cell Transplantation in Systemic Lupus Erythematosus
This trial is designed to evaluate the safety of treating systemic lupus erythematosus participants with cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell transplant. There will be no randomization in this study. All subjects who are determined to be eligible for the study treatment will receive cyclophosphamide and CAMPATH-1H followed by allogeneic stem cell transplant. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease.
Triptorelin for Ovary Protection in Childhood Onset Lupus
The purpose of this study is to test the safety of triptorelin when used for the protection of the ovaries (pair of female reproductive organs) during cyclophosphamide therapy for systemic lupus erythematosus (SLE; lupus) and to see what effects (good or bad) it has on patients. The study will be done with female patients who have been diagnosed with systemic lupus erythematosus, are younger than 21 years of age, and require intravenous cyclophosphamide to control the disease. Each patient will be in the study for approximately 23 months, until 4 months after the intravenous cyclophosphamide treatment has been completed.
Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (April SLE)
This study is intended to evaluate the use of atacicept compared to placebo in reducing the number of flares for people with SLE. The study is randomized and is designed to find the most effective dose of atacicept. Study medication is administered via subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by weekly doses for one year. Follow-up will continue for an additional 24 weeks.
Immunogenicity and Safety of HPV Vaccine Gardasil in Young Women
Female patients with systemic lupus erythematosus (SLE) have been found have higher rates of persistent HPV infections and precancerous lesions compared to the healthy population. The HPV vaccine Gardasil has been found to be safe and efficacious in females aged 9 to 26 years. There are no data on the immunogenicity and safety of Gardasil in females with SLE. Immune dysfunction related to SLE itself and the immunosuppression secondary to treatment of SLE might prevent patients with SLE from developing an adequate immune response to the vaccine. Also, theoretically, the vaccine might induce a disease exacerbation or production of new autoantibodies. The purpose of this study is to evaluate immunogenicity and safety of Gardasil and its effects on autoantibody profile in female SLE patients aged 9-26 years.
Genetic Risk Factors Associated With Antiphospholipid Antibody Syndrome
Antiphospholipid antibody syndrome (APS) is characterized by the presence of antiphospholipid antibodies, which are proteins in the blood that interfere with the body's ability to perform normal blood clotting. Clinical problems associated with antiphospholipid antibodies include an increased risk for the formation of blood clots in the lungs or deep veins of the legs, stroke, heart attack, and recurrent miscarriages. It is possible that some people with APS have a genetic predisposition for developing the syndrome. This study will use a genetic strategy to identify potential inherited risk factors for the development of APS by recruiting people with APS who have family members also affected by the syndrome or by another autoimmune disorder, such as lupus or rheumatoid arthritis.
Hematopoietic Stem Cell Support in Vasculitis
In spite of modern therapeutic immune suppressive agents, there remains a not inconsequential morbidity and mortality associated with systemic necrotizing vasculitis (SNV). The current standard therapy for SNV is chronic oral cyclophosphamide (1-3 mg/kg/day) and corticosteroids (3-6). Transplant doses of cyclophosphamide at 200 mg/kg infused over 4 days is the most common worldwide transplant regimen for systemic lupus erythematosus (SLE) (7). Like SLE, SNV are cyclophosphamide responsive disease. We, therefore, propose a trial of high dose cyclophosphamide with anti-thymocyte globulin (ATG) for patients with SNV.
Dehydroepiandrosterone (DHEA) in Systemic Lupus Erythematosus (SLE) for Coronary Artery Disease (CAD) Prevention
The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring:
1. changes in brachial artery flow-mediated dilatation (FMD) and
2. changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized, double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to the alternate treatment arm after a six-week washout period.
HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease.
Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis
This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 40 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will enroll SLE subjects with GN into 2 cohorts. The purpose of the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and pharmacokinetics.
Vitamin D Status, Disease Specific and Quality of Life Outcomes in Patients With Cutaneous Lupus
Sponsored by the Dermatology Foundation of Emory University, this Phase 2 study aims to determine if increasing levels of Vitamin D influence severity and quality of life for patients with cutaneous (skin) lupus, and might suggest a cost-effective additional therapy to our standard clinical practice.
The rationale for the study is based on evidence that low levels of vitamin D have been associated with an increased risk of other autoimmune disorders such as diabetes and multiple sclerosis, and have also been found to be common in skin lupus patients. Investigators seek to identify how many skin lupus patients have low vitamin D status and how vitamin D influences the natural history of this skin disease. Additionally the investigators will evaluate whether or not supplementation with high dose vitamin D will lessen the severity and negative quality of life impact of skin lupus.
To participate, patients must be at least 18 and diagnosed with cutaneous lupus and cannot have systemic lupus erythematosus among other medical criteria.
To Evaluate the Preliminary Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of CC-11050 in Subjects With Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus
This is the first study in cutaneous lupus erythematosus subjects to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CC-11050. Patients must be at least 18 and be diagnosed with Discoid Lupus Erythematosus and Subacute Cutaneous Lupus Erythematosus among other criteria including active skin lesions. The study lasts 12 weeks; three out of four patients will receive the investigational drug. CC-11050 is an oral anti-inflammatory compound in investigation by Celgene.
A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
Now actively enrolling, this Phase I study is designed to evaluate the safety and tolerability of varying dosages of the investigational human monoclonal antibody PD-0360324 in patients with cutaneous lupus erythematosus. Changes in the levels of disease activity will also be evaluated including lessening of symptom severity. To enroll, patients can be male or female and must be between the ages of 21 to 70 and be diagnosed with either discoid cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus with or without systemic lupus erythematosus among other criteria. This trial will last 16 weeks. In development by Pfizer, PD-0360324 is a novel human monoclonal antibody against the monocyle/macrophage colony stimulating factor (M-CSF). The monocyte/macrophage colony stimulating factor is part of a natural immune and inflammatory cascade, but it also has been identified as an agent involved in the over-production of substances involved in autoimmune diseases such as lupus.
A Research Study to Assess if CC-930 is Safe in Treating Subjects With Discoid Lupus Erythematosus
Now actively enrolling, the purpose of this Phase II study is to assess if the investigational kinase inhibitor CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. The study will also evaluate how CC-930 is absorbed, distributed, metabolized, and excreted by the body (Pharmacokinetics) and how its effects on the body (pharmacodynamics). Patients can be male or female and must be 18 – 64 years of age and diagnosed with Discoid Lupus Erythematosus among other criteria. CC-930 is in development by Celgene.
Velcade for Proliferative Lupus Nephritis
The primary objective of this Phase IV trial is to test the safety and efficacy of Velcade to induce remission in patients with WHO class III/IV/V lupus nephritis who are resistant to standard medications typically used to treat the disease. This exploratory single center, open-label, single treatment group assignment, safety, and efficacy study will enroll 14 patients. The study is sponsored and being conducted at The Rogosin Institute in New York City. Patients are in the study for one year.
A Study of the Safety and Efficacy of an Interleukin-6 Inhibitor in Patients With Lupus Nephritis
The purpose of this Phase II trial is to evaluate the safety and effectiveness of CNTO 136 (an anti-interleukin-6 antibody) administered by infusion to patients with active lupus nephritis (LN). CNTO 136 is a protein that blocks interleukin-6, a substance in the body that is overproduced when lupus patients have kidney inflammation. Eligible patients are those with Class III or IV LN who have a defined degree of protein losses into urine despite use of standard therapies. Patients will be randomly assigned to receive infusions every 4 weeks of either CNTO 136 or placebo for 24 weeks, in addition to their normal therapy for LN. The study lasts for 48 weeks. CNTO 136 is in development by Centocor, Inc.
ATLAS - Anti-Tweak in Lupus Nephritis Patients
This Phase 2 study is designed to evaluate the efficacy, safety, and tolerability of BIIB023 in treating lupus nephritis (kidney disease associated with lupus). BIIB023 is a human monoclonal antibody in development by Biogen Idec. To participate, patients must be 18 to 75 years of age, have been diagnosed with systemic lupus erythematosus and at least Class III level of lupus nephritis (kidney disease). Patients will be randomly selected for treatment with either of two doses of BIIB023 plus standard therapy or standard therapy and placebo. Safety, effectiveness and side effects of BIIB023 will be measured up to 72 weeks.
A Study of Belimumab in the Prevention of Kidney Transplant Rejection
Not yet enrolling patients as of April 20, 2012, this Phase 2 study will test whether an approved lupus treatment, belimumab (Benlysta), could help prevent the body’s immune system from rejecting a kidney transplant. Kidney transplantation is the best treatment for many patients with kidney failure. However, a transplanted kidney may be rejected by the patient's immune system, particularly in a patient with lupus. Many types of immune system cells, including B cells, are involved in causing the body to reject the transplanted organ. B cells produce antibodies against anything the body sees as non-self, like germs or a transplanted kidney. Most medicines that help prevent transplant rejection affect cells other than B cells. Belimumab slows development of antibody-producing B cells. Twenty adults 18 to 75 years of age who are getting a kidney transplant will be in this study. Half will receive belimumab while the other half receives placebo and be part of the study for one year. The pharmaceutical company, GlaxoSmithKline, is funding the study.
Lupus Nephritis Biomarker Study: Baseline Characteristics of Patients
The objectives of this observational study are to follow Lupus Nephritis patients over a period of 12 months to: establish the baseline biomarker characteristics of patients; determine the variability of biomarker measures over time; and correlate biomarkers with the characteristics of disease. To participate, male or female patients must be at least 18 and diagnosed with either of the two most common forms of lupus nephritis, Class III or Class IV among other criteria. People in the control group cannot have lupus nephritis but must have idiopathic glomerular disease meaning kidney disease of unknown cause that affects the glomerulus (a tiny ball-shaped structure responsible for filtering the blood to form urine.) The study is co-sponsored by Columbia University and Centocor Research & Development, Inc.
Rituximab in Progressive IgA Nephropathy
Recent clinical success in the use of Rituximab in the treatment of Lupus nephritis and other forms immune complex glomerulonephritis has led to its investigation in the treatment of IgA nephropathy. Because IgA class antibodies have comparatively short half-lives and that deposition of polymeric forms of IgA contributes to glomerular injury, we speculate that the reduction of circulating IgA may reduce proteinuria and injury in patients with IgA nephropathy. Moreover, the absence of prospective trials in the treatment of IgA disease and the lack of consensus for long-term treatment, the superior side-effect profile of this form of therapy may lead to significant advances in the treatment of this prevalent from of glomerulonephritis.
Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis (ACCESS)
This study is for people with lupus who have developed complications in their kidneys, or lupus nephritis. The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.
This information does not represent endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact LupusTrials.org for information on these studies. Only contact the listed numbers. LupusTrials.org does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.