| CTRI Number |
CTRI/2021/06/034421 [Registered on: 28/06/2021] Trial Registered Prospectively |
| Last Modified On: |
28/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Study of Oral Cyclophosphamide and Mycophenolate mofetil in Childhood Nephrotic Syndrome |
|
Scientific Title of Study
|
A Comparative Study of Oral Cyclophosphamide vs Mycophenolate Mofetil in Children with Frequent Relapsing Steroid Dependent Nephrotic Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gurdeep Singh Dhooria |
| Designation |
Associate Professor, Department of Pediatrics |
| Affiliation |
Dayanand Medical College and Hospital, LudhianaAND HOSPITAL, LUDHIANA, PUNJAB, INDIA |
| Address |
Room No. 209, 2nd Floor,
Dayanand Medical College and Hospital, Ludhiana, Punjab, India
Ludhiana
PUNJAB
141012
India |
| Phone |
09915515234 |
| Fax |
|
| Email |
gurdeep2005123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurdeep Singh Dhooria |
| Designation |
Associate Professor, Department of Pediatrics |
| Affiliation |
Dayanand Medical College and Hospital, LudhianaAND HOSPITAL, LUDHIANA, PUNJAB, INDIA |
| Address |
Room No. 209, 2nd Floor,
Dayanand Medical College and Hospital, Ludhiana, Punjab, India
Ludhiana
PUNJAB
141012
India |
| Phone |
09915515234 |
| Fax |
|
| Email |
gurdeep2005123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurdeep Singh Dhooria |
| Designation |
Associate Professor, Department of Pediatrics |
| Affiliation |
Dayanand Medical College and Hospital, LudhianaAND HOSPITAL, LUDHIANA, PUNJAB, INDIA |
| Address |
Room No. 209, 2nd Floor,
Dayanand Medical College and Hospital, Ludhiana, Punjab, India
Ludhiana
PUNJAB
141012
India |
| Phone |
09915515234 |
| Fax |
|
| Email |
gurdeep2005123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Ludhiana, Punjab, India |
|
|
Primary Sponsor
|
| Name |
GURDEEP SINGH DHOORIA |
| Address |
H.N. 753- I BLOCK, BHAI RANDHIR SINGH NAGAR, LUDHIANA, PUNJAB |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dayanand Medical College and Hospital Ludhiana Punjab |
Tagore Nagar, Ludhiana |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gurdeep Singh Dhooria |
Dayanand Medical College and Hospital, Ludhiana, Punjab |
WARD NUMBER 209, II FLOOR,
Department of Pediatrics
Ludhiana
PUNJAB |
09915515234
gurdeep2005123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, DAYANAND MEDICAL COLLEGE AND HOSPITAL, LUDHIANA |
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 |
Oral Cyclophosphamide |
Oral Cyclophosphamide Dose: 2-2.5mg/kg once a day. Duration: 8-12 weeks therapy. Total cumulative dose less than 168mg/kg.
Already published data Title
" Oral cyclophosphamide therapy in 100 children with steroid-sensitive nephrotic syndrome: experience from a developing country"
Journal
Pediatric Nephrology, (), 1-9
DOI
10.1007/s00467-021-05052-5
Your article is available as Online First:
http://link.springer.com/article/10.1007/s00467-021-05052-5 will be taken as control. |
| Intervention |
Oral Mycophenolate Mofetil |
Oral Mycophenolate mofetil (Dose: 750-1000 mg/ m2) in two divided dosages. Duration: at-least 12 months. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with Frequent Relapsing Steroid Dependent Nephrotic Syndrome |
|
| ExclusionCriteria |
| Details |
1. Congenital Nephrotic Syndrome
2. Steroid Resistant Nephrotic Syndrome
3. Patients with an estimated glomerular filtration rate (<60 ml/min
per 1.73 m2
4. Known secondary causes including systemic lupus, Henoch
Schonlein purpura, IgA nephropathy or chronic infection (tuberculosis, HIV, hepatitis B or C.
5. Prior therapy with MMF, cyclosporine, tacrolimus, or cyclophosphamide in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of children off steroids for atleast 6 months after starting treatment with MMF OR children off steroids for atleast 6 months after 8-12 weeks course of oral cyclophosphamide will be defined as Responders |
At baseline, 3 months, 6 months, 9 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first relapse.
|
In months - till end of 12 months period |
| Number of relapses in 12 months of therapy |
In numbers at the end of 12 months period |
| Proportion of Frequent relapsers (more than or equal to 3) in 12 months of MMF therapy |
Percentage till end of 12 months |
| Proportion of Infrequent Relapsers after 12 months of therapy |
Percentage at 12 months period |
| Frequency of side effects in each group |
In Numbers and Proportion till end of 12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/06/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gurdeep2005123@gmail.com].
- For how long will this data be available start date provided 07-12-2022 and end date provided 07-12-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Children with
frequent relapsing steroid dependence Nephrotic Syndrome are at risk of
complications during relapses and adverse effects of corticosteroid and other
immunosuppressive therapies. Studies have suggested that relapses in frequently
relapsing (FR) steroid dependant (SD) nephrotic syndrome are reduced by use of
steroid-sparing agents such as Oral cyclophosphamide or mycophenolate mofetil
(MMF). Given their side effect and toxicity
concerns of oral cyclophosphamide, most expert groups now recommend levamisole or
MMF in such patients with frequent relapses, before therapy with
cyclophosphamide or calcineurin inhibitors are considered. The comparative
efficacy of these agents has not been studied in Indian children. This
single-center, open-label, non-randomized active controlled non inferiority trial,
will be conducted on children who have received at-least 12 months of treatment
of MMF or a single course of oral cyclophosphamide of 8-12 weeks duration with
at-least 12 months follow-up period (post CYP) between June 2021 and July 2022.
Their efficacy and safety in reducing the frequency of relapses in patients
with FR/SD nephrotic syndrome will be compared. |