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Compare Efficacy and Safety of Repeated Courses of Rituximab to That of Maintenance Mycophenolate Mofetil Following Single Course of Rituximab Among Children With Steroid Dependent Nephrotic Syndrome

NCT03899103 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-17

No results posted yet for this study

Summary

The aim of the RITURNS II study is to evaluate the efficacy and safety of Repeat courses of Rituximab to that of maintenance Mycophenolate Mofetil following single course of Rituximab in maintaining remission over 24 months among Children with Steroid Dependent Nephrotic Syndrome (SDNS).

Conditions

  • Steroid-Dependent Nephrotic Syndrome

Interventions

DRUG

Rituximab

First course Course Rituximab at Randomization.

DRUG

Mycophenolate Mofetil

Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards

Sponsors & Collaborators

  • Heidelberg University

    collaborator OTHER

  • Nilratan Sircar Medical College

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2023-09-05
Completion
2023-12-24

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03899103 on ClinicalTrials.gov