WithdrawnPhase 3

Randomized Trial Evaluating Mycophenolate Mofetil in Children With Nephrotic Syndrome After Rituximab Treatment

Stopped: lack of funding

China0Started 2021-01-01

Plain-language summary

The aim of this study is to evaluate the efficacy and safety of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 12 months among Children with frequently-relapsing or steroid-dependent nephrotic syndrome

Who can participate

Age range1 Year – 16 Years

SexALL

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Inclusion criteria

✓. Children between 1 and 16 years with Frequently-relapsing or Steroid-dependent Nephrotic Syndrome
✓. Estimated glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry.
✓. Remission at study entry
✓. Patients in whom ≥5 CD20-positive cells/μL are observed in the peripheral blood.
✓. Parents willing to give informed written and audiovisual consent.

Exclusion criteria

✕. Patients who have been diagnosed with nephritic- NS, such as immunoglobulin A(IgA) nephropathy, prior to assignment or in whom secondary NS is suspected.
✕. Patients showing one of the following abnormal clinical laboratory values:

What they're measuring

1-year relapse-free survival rate

Timeframe: 1-year period after randomization

Trial details

NCT IDNCT04531865

SponsorChildren's Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-01

View on ClinicalTrials.gov More Frequently Relapsing Nephrotic Syndrome trials