- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03180723
Effect of Rituximab in Treatment of Membranoproliferative Glomerulonephritis
Effect of Rituximab in Treatment of Primary Membranoproliferative Glomerulonephritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Type I MPGN is associated with a variety of disorders, including hepatitis, especially hepatitis C, cryoglobulinemia, monoclonal gammopathies, systemic lupus erythematosus, and bacterial endocarditis or other chronic bacterial infections . Idiopathic Type I MPGN is rare. Biopsy samples usually stain for C3 and properdin. However, immunoglobulin G is also present in most cases, especially if the biopsy is performed early in the course of the disease suggesting antibody production as a possible therapeutic target.
Rituximab is a chimeric murine/human immunoglobulin g1 kappa monoclonal antibody targeting the cluster of differentiation 20 antigen found on pre-B and mature B lymphocytes, but not on hematopoietic stem cells, pro-B cells, normal plasma cells or the cells of other normal tissues. In the United States it was approved by the US Food and Drug Administration in 1997 for non-Hodgkin's lymphoma and was later approved for rheumatoid arthritis. Intravenous administration of rituximab results in rapid, selective, prolonged B cell depletion.
Anecdotal reports have demonstrated the efficacy of rituximab in treating MPGN secondary to chronic lymphocytic leukemia. Rituximab has also been shown to be effective in patients with MPGN related to a monoclonal gammopathy.
In an open label trial with rituximab, six patients with MPGN type I were treated with rituximab 1000 mg on days 1 and 15 and followed for 1 year. Proteinuria fell in all patients, at all time points, after rituximab administration. Renal function did not change.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- MPGN either native/renal transplant kidneys with biopsy last 3 years.
- Age > 18 years.
- Urinary protein to creatinine ratio > 1.0 in a 24-hour urine collection, despite angiotensin converting enzyme inhibitor/angiotensin receptor blocker treatment.
- Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to enrollment with the systolic blood pressure < 140 mm Hg for at least 75% of readings.
- Women must be post-menopausal, surgically sterile or practicing a medically approved method of contraception.
- Patients intolerant of ACE inhibitors/ARBs may enter the study without being treated with these agents.
- Estimated glomerular filtration rate ≥ 25 ml/min per 1.73m^2 in the presence of ACE inhibitor/ARB therapy. The GFR will be estimated using the 4 variable Modification of Diet in Renal Disease (MDRD) equation/National Kidney Foundation - Chronic Kidney Disease (NKF-CKD) guidelines.
- Adequate liver function.
- Negative serum pregnancy test (for women of child bearing age).
Exclusion Criteria:
- Age <18 years.
- Secondary MPGN.
- Presence or suspicion of active infection.
- Pregnancy.
- Concomitant malignancies, Major psychiatric disorder. Significant cardiac or pulmonary disease and any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory suspicion of a disease/condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
Laboratory Exclusion Criteria (Screening):
- Hemoglobin:< 8.5 gm/dL
- Platelets:< 100,000/mm
- Total bilirubin, Aspartate amino transferase, alkaline phosphatase > 2.5 x Upper Limit of Normal unless related to primary disease
- Positive Hepatitis B or C serology
- Positive human immunodeficiency virus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group
Rituximab is given in 2 doses (1 gm each dose) to a group of15 patients with primary membranoproliferative glomerulonephritis at (0 - after 2 weeks)
|
Intravenous injection
|
Active Comparator: control group
Cyclosporine is given orally in a dose of 2mg/kg/d for 3 months to another group of patients with primary membranoproliferative glomerulonephritis.
|
Oral tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
effect of Rituximab on proteinuria
Time Frame: 3 months
|
measured through urinary protein/ creatinine ratio
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Kidney Diseases
- Urologic Diseases
- Nephritis
- Glomerulonephritis
- Glomerulonephritis, Membranoproliferative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Rituximab
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- RMPGN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Membranoproliferative Glomerulonephritis
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Alexion PharmaceuticalsAchillion, a wholly owned subsidiary of AlexionCompletedC3 Glomerulopathy | C3 Glomerulonephritis | Dense Deposit Disease | Immune Complex Mediated Membranoproliferative Glomerulonephritis | Membranoproliferative Glomerulonephritis Types I, II, and IIINetherlands, Australia, Belgium
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Celldex TherapeuticsTerminatedC3 Glomerulonephritis | Dense Deposit Disease | Membranoproliferative Glomerulonephritis Type IIUnited States
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Mario Negri Institute for Pharmacological ResearchAlexion PharmaceuticalsCompletedIC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Dense Deposit Disease | Immune Complex Membranoproliferative GlomerulonephritisItaly
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Mayo ClinicCompletedGlomerulonephritis, MembranoproliferativeUnited States
-
AlexionTerminatedIC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Dense Deposit Disease | Immune Complex Membranoproliferative GlomerulonephritisUnited States, Australia, Belgium, Italy, Netherlands
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Apellis Pharmaceuticals, Inc.Active, not recruitingC3G | IC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Complement 3 Glomerulopathy | Complement 3 Glomerulopathy (C3G) | Complement 3 Glomerulonephritis | Dense Deposit Disease | DDD | Membranoproliferative Glomerulonephritis | Membranoproliferative Glomerulonephritis (MPGN) | Immune Complex Membranoproliferative...United States, Spain, France, Germany, United Kingdom, Netherlands, Brazil, Israel, Japan, Australia, Austria, Italy, Switzerland, Korea, Republic of, Czechia, Belgium, Argentina, Canada, Poland
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Apellis Pharmaceuticals, Inc.Active, not recruitingC3G | IC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Complement 3 Glomerulopathy | Complement 3 Glomerulopathy (C3G) | Complement 3 Glomerulonephritis | Dense Deposit Disease | DDD | Membranoproliferative Glomerulonephritis | Membranoproliferative Glomerulonephritis (MPGN) | Immune Complex Membranoproliferative...United States, Australia, Brazil, Czechia, France, Italy, Korea, Republic of, Netherlands, Spain, Switzerland, United Kingdom
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Apellis Pharmaceuticals, Inc.AvailableC3G | IC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Complement 3 Glomerulopathy | Complement 3 Glomerulopathy (C3G) | Complement 3 Glomerulonephritis | Dense Deposit Disease | DDD | Membranoproliferative Glomerulonephritis | Membranoproliferative Glomerulonephritis (MPGN) | Immune Complex Membranoproliferative...United States
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Columbia UniversityAlexion PharmaceuticalsCompletedDense Deposit Disease | Membranoproliferative GlomerulonephritisUnited States
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Fernando FervenzaCompleted
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Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingEBV-Related Post-Transplant Lymphoproliferative Disorder | Monomorphic Post-Transplant Lymphoproliferative Disorder | Polymorphic Post-Transplant Lymphoproliferative Disorder | Recurrent Monomorphic Post-Transplant Lymphoproliferative Disorder | Recurrent Polymorphic Post-Transplant Lymphoproliferative... and other conditionsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Small Lymphocytic Lymphoma | Prolymphocytic Leukemia | Recurrent Chronic Lymphocytic LeukemiaUnited States
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National Cancer Institute (NCI)Celgene CorporationActive, not recruitingAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
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PfizerCompletedRheumatoid ArthritisUnited States, Australia, Canada, Israel, Mexico, Colombia, Germany, Russian Federation, South Africa, United Kingdom
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Mabion SAParexelWithdrawn
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