FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/01/004355 [Registered on: 28/01/2014] Trial Registered Prospectively
Last Modified On: 19/09/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare effectiveness for preventing disease recurrence and safety regarding drug related side effects between a newer-safe drug(Rituximab) and conventionally used drug(Calcineurin Inhibitors)in children with difficult to treat nephrotic syndrome, a chronic protein loosing kidney disease. 
Scientific Title of Study
Modification(s)  
Randomized Clinical Trial to Compare Efficacy and Safety of Rituximab to That of Calcineurin Inhibitor in Children With Steroid Dependent Nephrotic Syndrome 
Trial Acronym  RITURNS (rituximab for relapse prevention in nephrotic syndrome) 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
NCT02438982  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Biswanath Basu 
Designation  Assistant Professor and In charge, Division of Pediatric Nephrology  
Affiliation  NRS Medical College and Hospital 
Address  Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road. Kolkata-14 WEST BENGAL

Kolkata
WEST BENGAL
700014
India 
Phone  913323453245  
Fax    
Email  basuv3000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Biswanath Basu 
Designation  Assistant Professor and In charge, Division of Pediatric Nephrology  
Affiliation  NRS Medical College and Hospital 
Address  Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road. Kolkata-14 WEST BENGAL

Kolkata
WEST BENGAL
700014
India 
Phone  913323453245  
Fax    
Email  basuv3000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Biswanath Basu 
Designation  Assistant Professor and In charge, Division of Pediatric Nephrology  
Affiliation  NRS Medical College and Hospital 
Address  Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road. Kolkata-14 WEST BENGAL

Kolkata
WEST BENGAL
700014
India 
Phone  913323453245  
Fax    
Email  basuv3000@gmail.com  
 
Source of Monetary or Material Support  
NRS Medical College and Hospital 
 
Primary Sponsor  
Name  NRS Medical College and Hospital  
Address  AJC Bose Road. Kolkata-14 WEST BENGAL 700014 India  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Self  NRS Medical College and Hospital  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Biswanath Basu  Room No.16, Div. of Pediatric Nephrology and OPD, Dept. of Pediatrics, NRS Medical College   NRS Medical College and Hospital, 138,AJC Bose Road. Kolkata-14 Kolkata WEST BENGAL
Kolkata
WEST BENGAL 
9231236001

basuv3000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee, NRS Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Nephrotic Syndrome ,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Rituximab  Two infusions will be administered intravenously at a 7-day interval at standard dose (rituximab 375mg/m2, maximum 500mg). Circulating B cells will be measured 24 hours after rituximab administration. If B cell count exceeds 5/mm3, it will be measured again after 1 week. If count still exceeds 5/mm3, two more doses of rituximab will be administered. 
Comparator Agent  Tacrolimus   Oral (Tablet form) 0.2mg/kg/day starting dose and continued over 12 months. Target tacrolimus trough level: 5-7 ng/ml.  
 
Inclusion Criteria
Modification(s)  
Age From  3.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details 
Children between 3 and 16 years with SDNS
Minimal Change disease/ FSGS/MesPGN as per Kidney Biopsy report.
Estimated glomerular filtration rate(eGFR) more than 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 less than 100 mg/dl for at least 3 days).
Not received any steroid sparing agent previously.
Parents willing to give informed written and audiovisual consent.
Ability to swallow tablet
 
 
ExclusionCriteria 
Details  Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS)
Patients with severe leucopenia (leucocytes less than 3.0× 1000 cells/mm3), severe anemia (haemoglobin less than 8.9 g/dl), thrombocytopenia (platelet less than 100.0 × 1000 cells/mm3) or deranged liver function tests (AST or ALT to more than 50 IU/L ) at enrolment.
Known active chronic infection (tuberculosis, HIV, hepatitis B or C)
 
 
Method of Generating Random Sequence
Modification(s)  
Stratified block randomization 
Method of Concealment
Modification(s)  
 
Blinding/Masking
Modification(s)  
Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
12-month relapse-free survival   12 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
eGFR at 3, 6, 9 and 12 months, respectively.
Amount of cumulative prednisolone requirement (mg/kg/yr) over 12 months
Number of relapses within months 0-12, 0-6 and 7-12.

Number of different steroid toxicity events (new onset) within month 0-12
Time to first relapse
Fraction of patients off steroids at month 12
Abnormal values in biochemical tests and haematology assessments.
Changes in Height sds and BMI sds from baseline to 12 months.

 
6,12 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial
Modification(s)  
Phase 3 
Date of First Enrollment (India)
Modification(s)  
08/05/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  
Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary    

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 FRNS. 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 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 our proposed randomized controlled trial, we want to compare the efficacy and safety of CNI to that of Rituximab in treating children with FRNS and SDNS.

 
Close