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

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ClinicalTrials.gov Identifier: NCT02382575
Recruitment Status : Recruiting
First Posted : March 6, 2015
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Biswanath Basu, Nilratan Sircar Medical College

Brief Summary:
The vast majority of children with idiopathic nephrotic syndrome respond well to corticosteroid treatment. However, as many as 20% experience a more complicated course with steroid resistance (SRNS). Repeated and prolonged courses of steroids in these children often result in long-term complications. The goal of 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 SRNS. 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. Rituximab infusion 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 this proposed randomized controlled trial, the investigators want to compare the efficacy and safety of CNI to that of Rituximab in treating children with SRNS.

Condition or disease Intervention/treatment Phase
Nephrotic Syndrome Drug: Rituximab Drug: Tacrolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Resistant Nephrotic Syndrome
Study Start Date : March 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tacrolimus
Tacrolimus: Standard dose with oral Tacrolimus 0.2 mg/kg/day in two divided doses till 6 month of relapse free survival.
Drug: Tacrolimus
Standard dose with oral Tacrolimus 0.2 mg/kg/day in two divided doses till 6 month of relapse free survival.
Other Name: Calcineurin inhibitor

Experimental: Rituximab
Two to four rituximab infusions (over 2-4 weeks) will be administered once every week at standard dose (Intravenous infusion of rituximab 375mg/mt2)depending on circulating B cells level.
Drug: Rituximab
Two to four rituximab infusions (over 2-4 weeks) will be administered once every week at standard dose (Intravenous infusion of rituximab 375mg/mt2)depending on circulating B cells level.
Other Name: anti CD20 monclonal antibody




Primary Outcome Measures :
  1. 12-month relapse-free survival in the intention-to-treat population [ Time Frame: 12-month ]


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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children between 3 and 16 years with SRNS
  • Minimal Change disease/Messengioproliferative glomerulonephritis/Focal segmental glomerulosclerosis as per Kidney Biopsy report.
  • Estimated glomerular filtration rate (eGFR) >80 ml/min per 1.73 m2 at study entry.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02382575


Locations
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India
NRS Medical College & Hospital Recruiting
Kolkata, West Bengal, India, 700014
Contact: Biswanath Basu    009123456731 ext 1804    basuv3000@gmail.com   
Principal Investigator: Biswanath Basu         
Sponsors and Collaborators
Nilratan Sircar Medical College
Investigators
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Principal Investigator: Biswanath Basu Assistant Professor

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Responsible Party: Dr. Biswanath Basu, Assistant Professor & In charge, Division of Pediatric Nephrology, Nilratan Sircar Medical College
ClinicalTrials.gov Identifier: NCT02382575     History of Changes
Other Study ID Numbers: PednephroRCT/PM/NRSMCH-33
CTRI/2015/01/005364 ( Registry Identifier: Clinical Trial Registry of India )
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Nephrotic Syndrome
Nephrosis
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Rituximab
Tacrolimus
Calcineurin Inhibitors
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action