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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

NCT ID: NCT03899103

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2023-12-24

Brief Summary

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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).

Detailed Description

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The vast majority of children with idiopathic nephrotic syndrome respond well to corticosteroid treatment. However, as many as 70% experience at least one relapse, and 30% develop a more complicated course with frequent relapses (FRNS) with or without steroid dependency (SDNS). Extended steroid exposure in these children often results in long-term complications. The management of patients with SDNS is challenging and expensive. Relapses may lead to serious complications, e.g. related to anasarca, hypertension, life threatening infections (peritonitis, pneumonia, meningitis), thrombosis and malnutrition. Repeated courses or even continuous steroid treatment lead to considerable medication related toxicity and morbidity.

The goal of treatment is to reduce the rate of relapses, the cumulative dose of corticosteroids, and the incidence of serious complications. Various prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population. Single rituximab infusion have been shown to be efficacious for 6 to 12 months and the side effect profile observed to date is very benign but after 6-8 months there was relapse due to regeneration of B-lymphocytes, hence for maintenance of remission MMF has been considered. In spite of good initial response, rituximab responders always remain prone to further relapse with regeneration of B lymphocytes, necessitating either repeat course of rituximab or addition of another steroid-sparing immunosuppressant. Reports suggest efficacy of rituximab may vary depending on disease pathology, clinical course, and simultaneous use of other immunosuppressants.

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

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Steroid-Dependent Nephrotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Repeated Courses of Rituximab Only

First course Course Rituximab at Randomization. Prophylactic 2nd and 3rd course rituximab re-administration will be done at 8 months and 16 months of follow-up if B cell count normalize.

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

First course Course Rituximab at Randomization.

Rituximab and Mycophenolate Mofetil

First course Course Rituximab at Randomization. Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards.

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

First course Course Rituximab at Randomization.

Mycophenolate Mofetil

Intervention Type DRUG

Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards

Interventions

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Rituximab

First course Course Rituximab at Randomization.

Intervention Type DRUG

Mycophenolate Mofetil

Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role collaborator

Nilratan Sircar Medical College

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Biswanath Basu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nilratan Sircar Medical College and Hospital

Kolkata, West Bengal, India

Site Status

Countries

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India

References

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Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.

Reference Type DERIVED
PMID: 39513526 (View on PubMed)

Chan EY, Yap DY, Colucci M, Ma AL, Parekh RS, Tullus K. Use of Rituximab in Childhood Idiopathic Nephrotic Syndrome. Clin J Am Soc Nephrol. 2023 Apr 1;18(4):533-548. doi: 10.2215/CJN.08570722. Epub 2023 Feb 22.

Reference Type DERIVED
PMID: 36456193 (View on PubMed)

Basu B, Preussler S, Sander A, Mahapatra TKS, Schaefer F. Randomized clinical trial to compare efficacy and safety of repeated courses of rituximab to single-course rituximab followed by maintenance mycophenolate-mofetil in children with steroid dependent nephrotic syndrome. BMC Nephrol. 2020 Nov 30;21(1):520. doi: 10.1186/s12882-020-02153-5.

Reference Type DERIVED
PMID: 33256621 (View on PubMed)

Other Identifiers

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PednephroRCT/NMC/586

Identifier Type: -

Identifier Source: org_study_id