Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childho… (NCT03560011) | Clinical Trial Compass
SuspendedPhase 2/3
Efficacy and Safety of Immunoglobulin Associated With Rituximab Versus Rituximab Alone in Childhood-Onset Steroid-dependent Nephrotic Syndrome
Stopped: Decision of Data Safety Monitoring Board
France90 participantsStarted 2019-04-03
Plain-language summary
Idiopathic Nephrotic Syndrome (INS) is the first glomerulopathy in children and 60% of the patients develop Steroid-Dependant Nephrotic Syndrome (SDNS). Recently, rituximab (RTX), a humanized anti-CD20 antibody depleting B cells demonstrated the ability to increase relapse free survival and to decrease the number of relapse and the need of other immunosuppressive drugs. However, the remission rate after 2 years is only 30 to 40%.
The aim of the study is to study the ability of intravenous Immunoglobulin to improve remission rate in SDNS when added associated with Rituximab compared to a treatment by Rituximab alone.
Who can participate
Age range
2 Years – 25 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:
* Childhood onset nephrotic syndrome (first flair \<18 years)
* ≥ 2 years old at inclusion
* Steroid-dependent:
* Patient with at least 2 relapses confirmed during the decay of corticosteroids or within 2 weeks following steroids discontinuation.
* Patient with at least 2 relapses including one under steroidsparing agent (MMF, Calcineurin inhibitors, cyclophosphamide, Levamisole) or within 6 months of treatment withdrawal.
* or with frequent relapses:
· 2 or more relapses within 6 months after initial remission or 4 or more relapses within any 12-month period.
* with a relapse within 3 months prior to inclusion
* In remission: Protein-over-creatinine ratio ≤ 0.2g/g (≤ 0.02g/mmol)
Exclusion Criteria:
* Patients with steroid-resistant nephrotic syndrome;
* Patients with genetic nephrotic syndrome;
* Patients previously treated with rituximab;
* Patients with no affiliation to a social security scheme (beneficiary or legal);
* Prior Hepatitis B, Hepatitis C or HIV infection;
* Pregnancy or breastfeeding.
* Patients with hyperprolinaemia,
* Known hypersensitivity to one of the study medication,
* Scheduled and not postponable injection of live attenuated vaccine
* Protected adults
* Patients with neutrophils \< 1.5 G/L and/or platelets \< 75 G/L
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.