CompletedPhase 3

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

India100 participantsStarted 2019-05-15

Plain-language 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).

Who can participate

Age range

3 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Children between 3 and 16 years with SDNS. * Minimal Change disease/ FSGS/MesPGN as per Kidney Biopsy report. * Estimated glomerular filtration rate (eGFR) \>80 ml/min per 1.73 m2 at study entry. * Remission at study entry (Urine albumin nil or trace (or proteinuria \<4 mg/m2/h) for 3 consecutive early morning specimens). * Not received any steroid sparing agent previously. * Parents willing to give informed written and audiovisual consent. * Ability to swallow tablet. Exclusion Criteria * Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS). * Patients with severe leukopenia (leukocytes \<3.0× 1000 cells/mm3), severe anemia (haemoglobin \<8.9 g/dl), thrombocytopenia (platelet \<100.0 × 1000 cells/mm3) or deranged liver function tests (AST or ALT to \>50 IU/L ) at enrolment. * Known active chronic infection (tuberculosis, HIV, hepatitis B or C). * Live vaccination within one month prior to screening.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The primary endpoint is the time to first relapse or death (whichever occurs first) till end of study (follow-up phase of 24 months)

Timeframe: 24 months

Trial details

NCT IDNCT03899103

SponsorNilratan Sircar Medical College

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2023-09-05

View on ClinicalTrials.gov More Steroid-Dependent Nephrotic Syndrome trials

Who can participate

Age range

3 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.