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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  
Status 
Not Applicable 
 
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. 

 
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