| CTRI Number |
CTRI/2020/07/026555 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
11/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Surveillance |
| Study Design |
Other |
|
Public Title of Study
|
Supervision of pediatric patients of childhood onset nephrotic syndrome on rituximab |
|
Scientific Title of Study
|
Active Safety surveillance study in pediatric patients of Childhood onset Nephrotic Syndrome on Rituximab therapy
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NILADRI SEKHAR DINGAL |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
IPGMER |
| Address |
DEPT OF PHARMACOLOGY
IPGMER
244 AJC BOSE ROAD
KOLKATA 700020
ATHILAGARI, CONTAI, EAST MIDNAPORE, WEST BENGAL, PIN 721401
Medinipur
WEST BENGAL
700020
India |
| Phone |
8145155758 |
| Fax |
|
| Email |
niladridingal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUPARNA CHATTERJEE |
| Designation |
PROFESSOR |
| Affiliation |
IPGMER |
| Address |
DEPT OF PHARMACOLOGY IPGMER 244 AJC BOSE ROAD KOLKATA 700020
DEPT OF PHARMACOLOGY IPGMER 244 AJC BOSE ROAD KOLKATA 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
|
| Fax |
|
| Email |
drsupchat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NILADRI SEKHAR DINGAL |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
IPGMER |
| Address |
DEPT OF PHARMACOLOGY
IPGMER
244 AJC BOSE ROAD
KOLKATA 700020
ATHILAGARI, CONTAI, EAST MIDNAPORE, WEST BENGAL, PIN 721401
Medinipur
WEST BENGAL
700020
India |
| Phone |
8145155758 |
| Fax |
|
| Email |
niladridingal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
INSTITUTIONAL RESEARCH FUND |
| Address |
Institute of Postgraduate Medical Education and Research
244 AJC bose road
kolkata 700020 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| NILADRI SEKHAR DINGAL |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH |
244 AJC BOSE ROAD
BHOWANIPORE
KOLKATA 700020
Kolkata
WEST BENGAL |
8145155758
niladridingal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N041||Nephrotic syndrome with focal andsegmental glomerular lesions, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of childhood onset nephrotic syndrome ≤18 years of age, of any gender, who have either received at least one dose of RTX in the last 3 months or shall receive rituximab in our hospital.
2. Subjects willing to give written informed consent and comply with study related instructions
|
|
| ExclusionCriteria |
| Details |
1. Subjects unwilling to give written informed consent and comply with study related instructions.
2. Subjects on rituximab therapy for any non-renal indications.
3. Subjects who have received the last dose of RTX more than 3 months back.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Since this is an active surveillance study in addition to clinical assessment variables and investigations advised by the attending clinician, the complete blood count and CD20 count will be evaluated by flow cytometry prior to administration of first dose and 8 weeks after completion of first course of therapy or earlier as advised by the attending clinician. |
All enrolled subjects shall be actively followed up every 2 months for the first 6 months and thereafter every 3 months upto 12 months from the date of initiation of RTX therapy for all suspected RTX induced ADR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO CHECK IF ANY ADVERSE REACTION PRESENT OR NOT |
AT THE END OF 2 MONTHS, 4 MONTHS, 6 MONTHS, 9 MONTHS, 12 MONTHS, 15 MONTHS, 18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/08/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
RESULT OF THIS STUDY SHALL BE CONSIDERED FOR PUBLICATION FOR ACADEMIC PURPOSE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this is an active safety surveilence study on childhood onset nephrotic syndrome who are recieving rituximab as treatment. our main focus is to locate any adverse reaction following rituximab. Diagnosed cases of childhood onset nephrotic syndrome (CONS)
who are refractory to conventional first
and second line immunosuppressant therapy attending the nephrology/ pediatrics
OPD/ IPD of this hospital shall be screened.Eligible subjects shall be categorized as two cohorts-
(1) RTX treatment naïve cohort- those who have been advised RTX and shall
receive the first dose in our hospital.
(2) RTX treated cohort: those who have been administered at least one
dose of RTX in the last 3 months from our hospital. All enrolled subjects shall be actively followed
up every 2 months for the first 6 months and thereafter every 3 months upto 12 months
from the date of initiation of RTX therapy for all suspected RTX induced ADR. Estimation
of CD20 count by flow cytometry will be done at the department of Pharmacology
and all other investigations as advised by the attending clinician required for
establishing causal association of the suspected adverse reaction to rituximab
shall be done form our hospital and recorded. The study is
intended to be completed within a period of eighteen months from initiation. |