Efficacy of Rituximab in Comparison to Continued Corticosteroid Treatment in Idiopathic Nephrotic Syndrome

Sponsor
Radboud University Medical Center
Study ID
NCT03298698
Phase
PHASE3
Status
Unknown

Conditions

  • Focal Segmental Glomerulosclerosis
  • Idiopathic Nephrotic Syndrome
  • Minimal Change Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab: 375 mg/m2 intravenously on day 0 and day 14 B-cells will be monitored weekly, and if no complete depletion is achieved, additional dose(s) of Rituximab will be given at a weekly interval until complete B cell depletion (maximum of 2 additional doses).
  • Prednisone — DRUG
    Prednisone 1 mg/kg/day (max 80 mg/day) for 8 weeks

Study Details

This will be an open-label, randomized controlled trial which compares continued treatment with high dose prednisone (standard therapy) to treatment with rituximab in patients with minimal change disease or focal segmental glomerulosclerosis unresponsive to 8 weeks of high dose prednisone . patients either receive 2 doses of Rituximab 375 mg/m2 iv at time 0 and 14 days with termination of prednisone or standard therapy which consist of 8 additional weeks of high dose prednisone treatment.

Key Dates

Start date
Aug 22, 2018
Status verified
Aug 2018
Primary completion
Aug 22, 2021
Completion
Jan 22, 2022

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
    Rituximab: 375 mg/m2 intravenously on day 0 and day 14 B-cells will be monitored weekly, and if no complete depletion is achieved, additional dose(s) of Rituximab will be given at a weekly interval until complete B cell depletion (maximum of 2 additional doses).
  • Active Comparator: Prednisone
    Prednisone 1 mg/kg/day (max 80 mg/day) for 8 weeks

Primary Outcome Measure

Complete remission [ Time Frame: 8 weeks ]

Central Contacts

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