drugset / Trial / NCT00498368
Rituximab in Progressive Immunoglobulin A (IgA) Nephropathy
Phase 4
Completed
34 enrolled
Mayo Clinic
Biogen · collabColumbia University · collabGenentech, Inc. · collabOhio State University · collabStanford University · collabUniversity of North Carolina, Chapel Hill · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study was about IgA nephropathy, a form of kidney disease characterized by the presence of blood and protein in the urine. This study was done to determine if the medication rituximab could reduce protein in the patient's urine. Hypothesis: In patients with progressive IgA nephropathy an intravenous infusion of 1000 mg of rituximab on Day 1 and Day 15 and Days 168 and 182 is superior to conventional therapy in reducing 24 hour proteinuria, and slowing progression of chronic kidney disease.
Timeline
- Start
- 2009-02
- Primary completion
- 2015-09
- Completion
- 2015-09
Outcome
Missed primary endpoint
paper In this trial, rituximab therapy did not significantly improve renal function or proteinuria assessed over 1 year. PMID 27821627 ↗
Publications
- Results Lafayette RA, Canetta PA, Rovin BH, Appel GB, Novak J, Nath KA, Sethi S, Tumlin JA, Mehta K, Hogan M, Erickson S, Julian BA, Leung N, Enders FT, Brown R, Knoppova B, Hall S, Fervenza FC. A Randomized, Controlled Trial of Rituximab in IgA Nephropathy with Proteinuria and Renal Dysfunction. J Am Soc Nephrol. 2017 Apr;28(4):1306-1313. doi: 10.1681/ASN.2016060640. Epub 2016 Nov 7.
- Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 1000 mg | Intravenous |