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CTRI Number  CTRI/2025/10/096742 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 16/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare two drugs (Rituximab and Tacrolimus) for treatment of difficult to treat kidney disease in children 
Scientific Title of Study   Randomized controlled trial to compare the efficacy of two doses of Rituximab versus Tacrolimus for maintenance of remission in difficult to treat SDNS 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anannya Biswas 
Designation  1st year Junior Resident of MD Paediatric  
Affiliation  IPGMER AND SSKM Hospital  
Address  Department of Paediatric medicine in IPGMER AND SSKM Hospital KOLKATA

Kolkata
WEST BENGAL
700020
India 
Phone  6290179823  
Fax    
Email  anannyabiswas16818@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sananda Pati 
Designation  Assistant Professor, Paediatric Medicine  
Affiliation  IPGMER AND SSKM Hospital  
Address  Department of Paediatric medicine in IPGMER AND SSKM Hospital KOLKATA

Kolkata
WEST BENGAL
700020
India 
Phone  9874066448  
Fax    
Email  sanandapati@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anannya Biswas 
Designation  1st year Junior Resident of MD Paediatric  
Affiliation  IPGMER AND SSKM Hospital  
Address  Department of Paediatric medicine in IPGMER AND SSKM Hospital KOLKATA

Kolkata
WEST BENGAL
700020
India 
Phone  6290179823  
Fax    
Email  anannyabiswas16818@gmail.com  
 
Source of Monetary or Material Support  
IPGMER AND SSKM Hospital, KOLKATA  
 
Primary Sponsor  
Name  Dr Anannya Biswas 
Address  Department of Paediatric medicine in IPGMER AND SSKM Hospital, KOLKATA  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anannya Biswas  IPGMER AND SSKM Hospital  Department of Paediatric medicine in IPGMER AND SSKM Hospital, KOLKATA Pin 700020
Kolkata
WEST BENGAL 		 6290179823

anannyabiswas16818@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N049||Nephrotic syndrome with unspecified morphologic changes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rituxumab  Dose: 375 mg/m² body surface area/ dose, IV infusion once a week for 2 weeks. Repeat infusions at 6-month (or as clinically indicated based on relapse or proteinuria levels) and at 12 months (or as clinically indicated based on relapse or proteinuria levels)  
Comparator Agent  Tacrolimus  Dose : 0.1 – 0.2 mg / kg / day in 2 divided doses . Target trough level : 5 – 10 ng /ml Duration: usually given 12 – 24 months, followed by slow taper if remission maintained. Dosing adjusted according to serum drug levels, renal function, and clinical response. Tapering schedule: Gradual reduction after achieving remission.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Patients with difficult to treat Steroid dependent nephrotic syndrome: Any 1 criteria met 1. Frequent relapses (Greater than or equal to 2 relapses in 6 months or greater than or equal to 3 relapses in 1 year) or steroid dependence 2. Failure of greater than or equal to 2 strategies ( alternate day prednisolone, levamisole, cyclophosphamide, MMF ) 3. Corticosteroid toxicity ( cataract , glaucoma ,short stature , low growth velocity , obesity )  
 
ExclusionCriteria 
Details  1. Active infection or history of recurrent severe infections. 2. Prior exposure to rituximab. 3. Severe cardiovascular or hepatic disease. 4. Uncontrolled comorbid conditions (e.g., diabetes, hypertension).  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Remission rate  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Time to remission    
Relapse rate  12 months 
Steroid sparing effect   12 months 
Side effects and adverse events   12 months 
Quality of life  12 months 
 
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   Phase 2 
Date of First Enrollment (India)   02/11/2025 
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   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a randomised, parallel group, trial comparing efficacy of two doses of rituxumab and tacrolimus in children (3-12 years age group) with difficult to treat steroid dependent nephrotic syndrome. The sample size of the study is 30 patients in each group. The primary outcome measure will be remission rate (complete or partial remission for at least 6 months) at 12 months. The secondary outcomes will be time to remission achieved, steroid sparing efficact , relapse rate , side effects and adverse events, quality of life.  
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