Randomized Trial Comparing Rituximab Against Mycophenolate Mofetil in Children Wtih Refractory Nephrotic Syndrome

Conditions

• Frequent Relapsing Nephrotic Syndrome
• Steroid Dependent Nephrotic Syndrome

Eligibility Criteria

Sex

ALL

Age

1 Year - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF
• MMF — DRUG
  Subjects randomized to MMF, will continue MMF as scheduled by the investigator

Study Details

We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective than MMF in maintaining remission in children with frequent relapsing or steroid dependent nephrotic syndrome who have had one relapse while receiving MMF. We will conduct a randomized study comparing two Rituximab infusions and continued MMF treatment. We plan to enroll 64 to have a comparater group of 58 (29 in each arm).

Key Dates

Start date

Jan 31, 2015

Status verified

Mar 2019

Primary completion

Dec 7, 2016

Completion

Jan 18, 2017

Study Design

Enrollment

3 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  Rituximab 375 mg/m2 will be administered intravenously on Study weeks 1 \& 3.
• Active Comparator: Mycophenolate Mofetil (MMF)
  Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months

Primary Outcome Measure

Relapse Free Survival [ Time Frame: 6 months ]

Locations (1)

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