Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Dependent Nephrotic Syndrome

July 30, 2017 updated by: Dr. Biswanath Basu, Nilratan Sircar Medical College
Nephrotic syndrome in children is primarily caused by minimal change disease. Majority of these patients respond well to corticosteroids. However, as many as 70% of children with nephrotic syndrome experience at least one relapse, and 30% develop a more complicated course with frequent relapses (FRNS)(≥2 relapses/ 6 months) with or without steroid dependency (SDNS)(relapse during tapering or within 2 weeks after discontinuation of corticosteroids). Repeated and prolonged courses of steroids in these children often result in long-term complications. The goal of the treatment is to reduce the rate of relapses, the cumulative dose of corticosteroids, and the incidence of serious complications. In order to minimize the side effects of steroid therapy, different steroid sparing agents such as cyclophosphamide, calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF) have been used in SDNS. Whereas CNI are usually considered the steroid sparing drug class of first choice, rituximab is increasingly used as alternative to minimize CNI toxicity. 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 course have been shown to be efficacious for 6 to 12 months and the side effect profile observed to date is very benign. Studies comparing the usefulness of these agents are lacking. In our proposed randomized controlled trial, the investigators want to compare the efficacy and safety of CNI to that of Rituximab in treating children with SDNS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • West Bengal
      • Kolkata, West Bengal, India, 700014
        • NRS Medical College & Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (trace or nil proteinuria, as determined by the dipstick test or <100 mg/dl for at least 3 days).
  • Not received any steroid sparing agent previously.
  • Parents willing to give informed written 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 leucopenia (leucocytes <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 1 mo

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tacrolimus
Oral Tacrolimus (Tablet form) 0.2mg/kg/day starting dose. Targeting trough level of Tacrolimus (T0) 5-7 ng/ml.
Drug: Tacrolimus
Oral Tacrolimus (Tablet form) 0.2mg/kg/day starting dose. Targeting trough level of Tacrolimus (T0) 5-7 ng/ml.
Other Names:
  • Calcineurin inhibitor
Experimental: Rituximab
Two rituximab infusions will be administered once every week at standard dose (Intravenous infusion of rituximab 375mg/mt2). Circulating B cells will be measured 24 hours after rituximab administration. If >5 B cells per mm3 , it will be measured again after 1 week. If count is still >5 B cells per mm3, third & fourth doses of rituximab will be given.
Drug: Rituximab
Two rituximab infusions will be administered once every week at standard dose (Intravenous infusion of rituximab 375mg/mt2). Circulating B cells will be measured 24 hours after rituximab administration. If >5 B cells per mm3, it will be measured again after 1 week. If count is still >5 B cells per mm3, third & fourth doses of rituximab will be given.
Other Names:
  • anti CD20 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
12-month relapse-free survival
Time Frame: 12-month
12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nilratan Sircar Medical College

Investigators

  • Principal Investigator: Biswanath Basu, Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2017

Last Update Submitted That Met QC Criteria

July 30, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pednephro RCT/PM/NRSMCH-54
  • CTRI/2014/01/004355 (Registry Identifier: Clinical Trial Registry of India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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