Membranoproliferative Glomerulonephritis Clinical Trial
Official title:
Effect of Rituximab in Treatment of Primary Membranoproliferative Glomerulonephritis
Type I membranoproliferative glomerulonephritis (MPGN) is a relatively uncommon glomerular disease, constituting 1.8% of renal biopsies performed in Rochester, minnesota, United States of America, at the Mayo Clinic, between 1993 and 2008. The prognosis of idiopathic Type I MPGN is relatively poor. Recently, Irish series, slightly more than 50% of patients developed end stage renal disease after a mean follow up of 14 years . The disease may recur after renal transplantation . High-dose glucocorticoids have been used to treat this disease in children but there is no established treatment in adults.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03095118 -
Daratumumab in Treatment of PGNMID and C3 GN
|
Phase 2 | |
| Recruiting |
NCT05985122 -
New Analytic Tools for aHUS and C3G Diagnosis
|
N/A | |
| Recruiting |
NCT04183101 -
Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy
|
Phase 2 | |
| Recruiting |
NCT06065852 -
National Registry of Rare Kidney Diseases
|
||
| Active, not recruiting |
NCT05067127 -
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
|
Phase 3 | |
| Active, not recruiting |
NCT05809531 -
An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
|
Phase 3 | |
| Completed |
NCT02093533 -
Eculizumab in Primary MPGN
|
Phase 2 | |
| Completed |
NCT01221181 -
Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy
|
Phase 1 | |
| Active, not recruiting |
NCT04572854 -
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
|
Phase 2 | |
| Recruiting |
NCT05996731 -
Developing a Pipeline to Employ RNA-Seq as a Complementary Diagnostic Tool in Rare Diseases
|
N/A | |
| Available |
NCT04729062 -
C3G/Primary IC-MPGN EAP
|