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Rituximab in the Treatment of Idiopathic Membranous Nephropathy

This study has been completed.
Genentech, Inc.
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic Identifier:
First received: November 29, 2006
Last updated: October 23, 2015
Last verified: October 2015
Membranous glomerulopathy (MN) is still the most common glomerular disease associated with nephrotic proteinuria (NS). Up to 40% of patients reach end stage renal failure (ESRD), making MN the 2nd or 3rd most common cause of ESRD caused by a primary glomerulopathy. Current treatment options include corticosteroids, alkylating agents, and cyclosporin, but their use is controversial and the associated adverse effects and high cost temper their usage. Experimental data in MN suggests that B cell activation results in immunoglobulin deposition along the glomerular basement membrane causing injury to the membrane and subsequent proteinuria. Drugs that non-selectively inhibit B cells and, these pathogenic antibodies, are closely associated with improved outcomes. Based on the rationale that selective depletion of B cells in humans would prevent the production of ?nephrotoxic? immunoglobulins and subsequent renal injury we recently treated 15 patients with MN with rituximab 1g i.v. twice (day 1 and day 15). Baseline proteinuria of 13.0±5.5g/24h decreased to 9.1±7g, 9.7±8g and 6.5±6 g/24h at 3, 6, and 9 months, respectively (mean ± SD). Analysis of the pharmacokinetic data obtained from this study, however, suggests that in heavily nephrotic patients, rituximab dosed in this fashion results in patients being under-treated. The present study propose to test the hypothesis that rituximab, given in accordance to the standard lymphoma protocol (375mg/m2 x 4), will result in a more effective and profound depletion of B cells, a more complete suppression of pathogenic antibodies, and a higher remission rate of the NS while maintaining a favorable safety profile.

Condition Intervention Phase
Membranous Nephropathy
Drug: Rituximab
Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rituximab in the Treatment of Idiopathic Membranous Nephropathy

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Primary endpoint. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Complete and partial remission rates at 6, 9, and 12 months [ Time Frame: 6, 9, and 12 months ]
  • Pharmacokinetics/bioavailability [ Time Frame: 12 months ]
  • Rate of decline in urinary protein [ Time Frame: 12 months ]
  • Frequency of relapse after CR [ Time Frame: 12 months ]
  • Toxicity [ Time Frame: 12 months ]

Enrollment: 20
Study Start Date: October 2006
Study Completion Date: April 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug
Drug: Rituximab
Patients will received rituximab 4 weekly doses of rituximab 375 mg/m2 at baseline. Patients will be retreated at 6 months.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Idiopathic MN with diagnostic biopsy performed within the past 24 months.
  • Age > 18 years
  • If female, must be post-menopausal, surgically sterile or practicing a medically approved method of contraception
  • Patients need to be treated with an ACEI and/or ARB, for at least 4 months prior to rituximab treatment and have adequately controlled blood pressure (BP <130/75 mm Hg in >75% of the readings).
  • Proteinuria as measured by urinary proteinuria / urinary creatinine > 5.0 on a spot sample aliquot from a 24-hour urine collection.
  • Estimated GFR &#8805; 30 ml/min/1.73m2 while taking ACEI/ARB therapy.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00405340

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Genentech, Inc.
Principal Investigator: Fernando C. Fervenza, M.D., Ph.D. Mayo Clinic
  More Information

Responsible Party: Fernando Fervenza, M.D., Ph.D., Mayo Clinic Identifier: NCT00405340     History of Changes
Other Study ID Numbers: 06-004833
Study First Received: November 29, 2006
Last Updated: October 23, 2015

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on April 28, 2017