CTRI Number	CTRI/2015/11/006345 [Registered on: 05/11/2015] Trial Registered Prospectively
Last Modified On:	04/11/2015
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Drug
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study	Efficacy of a shorter duration of prednisolone treatment for children in relapse with steroid sensitive nephrotic syndrome: A randomised controlled study
Scientific Title of Study	Efficacy of short prednisolone treatment for relapse in children with steroid sensitive nephrotic syndrome: A randomised controlled study
Secondary IDs if Any	Secondary ID  Registry  nil  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Prof Pankaj Hari  Address  Room no: 3061, 3rd floor, teaching block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 New Delhi DELHI 110029 India  Phone  01126594858   Fax     Email  pankajhari@hotmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Deepika  Address  Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 New Delhi DELHI 110029 India  Phone  9968859769   Fax     Email  aiims.deepika@gmail.com
Details Contact Person Public Query	Name  Prof Pankaj Hari  Address  Room no: 3061, 3rd floor, teaching block, All India Institute of Medical Sciences, Ansari Nagar, New Delhi All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029 New Delhi DELHI 110029 India  Phone  01126594858   Fax     Email  pankajhari@hotmail.com
Source of Monetary or Material Support	ICMR
Primary Sponsor	Name  ICMR  Address  Ansari Nagar, Post Box 4911, New Delhi 110029  Type of Sponsor  Government funding agency
Details of Secondary Sponsor	Name  Address  Nil  Nil
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Prof Pankaj Hari  All India Institute of Medical Sciences  Room No. 3061, 3rd floor, teaching block, All India Institute of Medical Sciences, Ansari Nagar New Delhi   01126594858 pankajhari@hotmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  All India Institue Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Steroid Sensitive Nephrotic Syndrome
Intervention / Comparator Agent	Type  Name  Details  Intervention  Prednisolone   Prednisolone 2 mg/kg daily till remission followed by 1.5 mg/kg alternate day for 2 weeks for relapse  Comparator Agent  Prednisolone   Prednisolone 2 mg/kg daily till remission followed by 1.5 mg/kg alternate day for 4 weeks in relapse
Inclusion Criteria	Age From  1.00 Year(s) Age To  16.00 Year(s) Gender  Both  Details  1. Patients diagnosed with steroid sensitive nephrotic syndrome 2. Currently in relapse 3. Those who give written informed consent
ExclusionCriteria	Details  1. Patients diagnosed with steroid resistant Nephrotic Syndrome 2. Patients with frequent relapses (defined as 2 or more relapses in 6 months or >3 in 12 months) or steroid dependence (defined as 2 consecutive relapses on alternate day therapy or within 2 weeks of discontinuation of therapy) 3. Known secondary cause (e.g. Hepatitis B, SLE, HSP) 4. Patients on alternate regimens with levamisole/cyclophospahmide/mycophenolate mofetil/azathioprine/rituximab 5. Patients who have not recieved atleast 4 weeks of daily steroids at 2 mg/kg followed by 4 weeks of 1.5 mg/kg alternate day steroids during initial episode
Method of Generating Random Sequence	Permuted block randomization, variable
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Open Label
Primary Outcome	Outcome  TimePoints  Proportion of children becoming frequently relapsing nephrotic syndrome  0 and 12 months
Secondary Outcome	Outcome  TimePoints  1. Time to first relpase 2. Relapse rates 3. Cumulative dose of steroids 4. Adverse effects of steroids  0, 1 mo, 3 mo, 6 mo, 9 mo, 12 mo
Target Sample Size	Total Sample Size="114" Sample Size from India="114"
Phase of Trial	Phase 3
Date of First Enrollment (India)	15/12/2015
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details	Nil
Brief Summary	This is an open label randomised controlled trial to determine the efficacy of a shorter duration of prednisolone treatment as 2 mg/kg daily till remission followed by 1.5 mg/kg alternate day therapy for 2 weeks in children with steroid sensitive nephrotic syndrome currently in relapse as compared to the standard therapy of relapse i.e 2 mg/kg daily therapy till remission followed by 1.5 mg/kg alternate day therapy for 4 weeks.The primary outcome is to determine the proportion of children becoming frequently relapsing nephrotic syndrome at the end of 12 month follow up period.