Effect of Rituximab in Treatment of Membranoproliferative Glomerulonephritis

Conditions

• Membranoproliferative Glomerulonephritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Intravenous injection
• Cyclosporin — DRUG
  Oral tablets

Study Details

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.

Key Dates

Start date

Jul 1, 2017

Status verified

Jun 2017

Primary completion

Jul 31, 2019

Completion

Dec 31, 2019

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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)
• 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.

Primary Outcome Measure

effect of Rituximab on proteinuria [ Time Frame: 3 months ]