| CTRI Number |
CTRI/2025/10/096461 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
19/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of one dose versus two dose injection Rituximab in children with steroid dependent nephrotic syndrome aged between 3-12 years who are difficult to treat with other medications. |
|
Scientific Title of Study
|
Effectiveness of single dose versus dual dose Rituximab in difficult-to-treat, steroid dependent nephrotic syndrome in children: A single blind Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renaissa Banik |
| Designation |
1st Year Pediatric Medicine Resident |
| Affiliation |
IPGMER and SSKMH |
| Address |
Pediatric medicine department, IPGMER and SSKM Hospital, Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
09382222804 |
| Fax |
|
| Email |
prrbanik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Atanu Roy |
| Designation |
Professor in Department of Pediatric Medicine |
| Affiliation |
IPGMER and SSKMH |
| Address |
Pediatric Medicine department IPGMER and SSKMH kolkata 700020 West Bengal India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9735362437 |
| Fax |
|
| Email |
atanuroy76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Atanu Roy |
| Designation |
Professor in Department of Pediatric Medicine |
| Affiliation |
IPGMER and SSKMH |
| Address |
Pediatric medicine department IPGMER and SSKMH Kolkata 700020 West Bengal India
Kolkata
WEST BENGAL
700020
India |
| Phone |
9735362437 |
| Fax |
|
| Email |
atanuroy76@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Renaissa Banik |
| Address |
Pediatric Medicine department IPGMER and SSKMH kolkata 700020 West Bengal India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sananda Pati |
IPGMER AND SSKMH |
Pediatric Medicine department
Kolkata
WEST BENGAL |
9874066448
sanandapati@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
|
|
|
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 |
| Comparator Agent |
Administration of double dose Rituximab |
Patients will receive single dose of Injection Rituximab 375 mg/m2 in the first week. In week 2 they will receive second dose Injection Rituximab. |
| Intervention |
Administration of single dose Rituximab |
Patients will receive single dose of injection Rituximab 375 mg/m2 in the first week. In week 2 they will receive placebo normal saline.
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All pediatric patients diagnosed with difficult to treat SDNS attending OPD/ IPD of department of pediatrics, IPGME&R aged 3 years to 12 years |
|
| ExclusionCriteria |
| Details |
Congenital nephrotic syndrome patients, aged less than 3 months
Nephrotic syndrome secondary to causes like , sickle cell disease, HIV, systemic lupus erythematosus, hepatitis B, malaria, parvovirus B19, medications
Patients with Hep B core antibody total positive, since Rituximab can lead to reactivation of latent hepatitis B virus.
Incomplete records
Did not give consent
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
We anticipate that single-dose Rituximab (375 mg/m²) will be non-inferior to double-dose Rituximab( two doses of 375mg/m2 given in 1week interval) in maintaining relapse-free remission in children with difficult-to-treat steroid-dependent nephrotic syndrome (SDNS).
The time to first relapse and the number of relapses in a year will be similar between the single-dose and double-dose groups.
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in cumulative steroid exposure will be similar between both groups, indicating effective steroid-sparing action even with a single dose.
2. B-cell depletion and reconstitution timelines may differ, but without a significant impact on clinical remission rates.
3. The relapse rates at 6 months and 12 months will not differ significantly between the two groups.
4. The single-dose group is expected to have a lower incidence of hypogammaglobulinemia.
|
18 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
|
N/A |
|
Date of First Enrollment (India)
|
13/11/2025 |
| 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
|
A randomized control trial has been planned. In Arm 1 we have the intervention group where Injection Rituximab will be given in the first week and in second week Normal Saline infusion will be given as placebo. In arm 2 we will give Inj Rituximab 1st dose in week 1 and 2nd dose in week 2. CD 19 counts will be measured 7 days after giving Rituximab then at 6 months or at time of relapse whichever is earlier. Follow up done till 12 months. Primary and secondary outcomes will be measured at the end of the study. |