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 | Completed Phase 3 DMC

• 1 other identifier: PednephroRCT/NMC/586
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (3)

• Cumulative prednisolone requirement (mg/kg/yr) over the first 12 and 24 months, respectively.

  12 and 24 months

• Number and severity of adverse events

  0-24 months

• Number of relapses within months 0-24, 0-12 and 12-24, respectively

  months 0-24, 0-12 and 12-24

Study Arms (2)

Repeated Courses of Rituximab Only

EXPERIMENTAL

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.

Drug: Rituximab

Rituximab and Mycophenolate Mofetil

ACTIVE COMPARATOR

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

Drug: Rituximab; Drug: Mycophenolate Mofetil

Interventions

Rituximab DRUG

First course Course Rituximab at Randomization.

Repeated Courses of Rituximab Only; Rituximab and Mycophenolate Mofetil

Mycophenolate Mofetil DRUG

Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards

Rituximab and Mycophenolate Mofetil

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nilratan Sircar Medical College: lead
• Heidelberg University: collaborator

Study Sites (1)

Nilratan Sircar Medical College and Hospital

Kolkata, West Bengal, 700014, India

Location

Related Publications (3)

• 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.

  PMID: 39513526 DERIVED

• 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.

  PMID: 36456193 DERIVED

• 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.

  PMID: 33256621 DERIVED

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Rituximab; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 2, 2019
• Study Start: May 15, 2019
• Primary Completion: September 5, 2023
• Study Completion: December 24, 2023
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

IN (1)