CTRI Number |
CTRI/2015/01/005363 [Registered on: 07/01/2015] Trial Registered Prospectively |
Last Modified On: |
02/03/2015 |
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 one month vs. two month of alternate day oral steroid in children with nephrotic syndrome, a chronic protein losing kidney disease. |
Scientific Title of Study
|
Efficacy and Safety of one month vs. two month of alternate day oral steroid in managing relapse of Idiopathic Steroid Sensitive 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 |
Biswanath Basu |
Designation |
Assistant Professor and In charge, Division of Pediatric Nephrology |
Affiliation |
NRS Medical College and Hospital |
Address |
Division of Pediatric Nephrology, Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road.
Kolkata
WEST BENGAL
700014
India
Kolkata WEST BENGAL 700014 India |
Phone |
3323453245 |
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 |
Division of Pediatric Nephrology, Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road.
Kolkata
WEST BENGAL
700014
India
WEST BENGAL 700014 India |
Phone |
3323453245 |
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 |
Division of Pediatric Nephrology, Dept. of Pediatrics, NRS Medical College and Hospital, AJC Bose Road.
Kolkata
WEST BENGAL
700014
India
WEST BENGAL 700014 India |
Phone |
3323453245 |
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 |
Biswanath Basu |
|
|
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 |
923123001
basuv3000@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee of NRS Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Nephrotic Syndrome , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Standard alternate day oral prednisolone. |
Standard alternate day oral prednisolone @ 1.5mg/kg for one month, after achieving remission with daily prednisolone. |
Intervention |
Tapering alternate day oral prednisolone |
Alternate day oral prednisolone @ 1.5 mg/kg for 10 days followed by @ 1.0 mg/kg for 20 days followed by @ 0.5 mg/kg for 30 days, after achieving remission with daily prednisolone. |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
16.00 Year(s) |
Gender |
Both |
Details |
Infrequent relapse nephrotic syndrome; No previously intake of any steroid sparing agent; Informed written consent. |
|
ExclusionCriteria |
Details |
Patients with severe leucopenia (leucocytes <3•0× 1000 cells/mm3), severe anemia (haemoglobin <8•9 g/dl), severe thrombocytopenia (platelet <100•0 × 1000 cells/mm3), deranged liver function tests (AST or ALT to >50 IU/L), or any active infection |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
sustained remission at 12 months |
3,6,9 and 12 month |
|
Secondary Outcome
|
Outcome |
TimePoints |
number of relapses, cumulative steroid dose |
3,6,9 and 12 month |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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 3/ Phase 4 |
Date of First Enrollment (India)
|
15/01/2015 |
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
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The vast majority of children with idiopathic nephrotic syndrome
respond well to corticosteroid treatment. However, as many as 80% experience a relapse. Repeated and prolonged
courses of steroids in these children often result in long-term complications.
The goal of 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 doses and
schedules are used. Standard therapy of 1 month alternate day steroid for managing
relapse results in further relapse among
50% of children. Various recent reports are suggesting that prolongation of
this alternate day steroid keeping the cumulative steroid load same, may
produce better efficacy in preventing further relapses.1-5 Studies
comparing the usefulness of these two schedules are lacking. In our proposed randomized controlled trial, we want
to compare the efficacy and safety of one month vs. two month of alternate day
oral steroid in managing relapse of Idiopathic Steroid Sensitive Nephrotic
Syndrome. |