| CTRI Number |
CTRI/2010/091/001095 [Registered on: 16/07/2010] |
| Last Modified On: |
03/06/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to compare the effectiveness and safety of treating the initial episode of nephrotic syndrome in children for a duration of three months versus six months |
Scientific Title of Study
Modification(s)
|
Randomized, double blind, placebo controlled trial to compare the efficacy of 3-months versus 6-months therapy with prednisolone for the first episode of idiopathic nephrotic syndrome in children |
| Trial Acronym |
None |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Arvind Bagga |
| Designation |
Professor |
| Affiliation |
|
| Address |
3053, Teaching Block
Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593472 |
| Fax |
011-26588480 |
| Email |
arvindbagga@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Arvind Bagga |
| Designation |
Professor |
| Affiliation |
|
| Address |
3053, Teaching Block
Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593472 |
| Fax |
011-26588480 |
| Email |
arvindbagga@hotmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Arvind Bagga |
| Designation |
Professor |
| Affiliation |
|
| Address |
3053, Teaching Block
Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593472 |
| Fax |
011-26588480 |
| Email |
arvindbagga@hotmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Indian Council of Medical Research, Delhi; ICMR Ref NO.5/4/7-11/10-NCD-II |
|
Primary Sponsor
Modification(s)
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research, Ansari Nagar, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arvind Bagga |
All India Institute of Medical Sciences |
3053, Teaching Block,Department of Pediatrics, All India Institute of Medical Sciences, Ansari Nagar-110029
New Delhi
DELHI |
011-26593472
011-26588480
arvindbagga@hotmail.com |
| Manish Kumar |
Chacha Nehru Bal Chikitsalaya |
403, Department of Pediatrics, Chacha Nehru Bal Chikitsalaya ,Geeta Colony-110031
New Delhi
DELHI |
09873589696
manishkp75@yahoo.com |
| Abhijeet Saha |
Dr. Ram Manohar Lohia Hospital |
Deaprtment of Pediatrics, Dr. Ram Manohar Lohia Hospital,Baba Kharak Singh Marg, Talkatora Road, near Connaught Place-110001
New Delhi
DELHI |
9711007064
drabhijeetsaha@yahoo.com |
| Kamran Afzal |
Jawahar Lal Nehru Medical College, ALigarh Muslim University |
Department of Paediatrics, Jawahar Lal Nehru Medical College, ALigarh Muslim University,Aligarh-202001
Aligarh
UTTAR PRADESH |
0571-2721182
drkafzal@hotmail.com |
| Amarjeet Mehta |
Sawai Man Singh (SMS) Medical College |
B 106, Arihant Apartments, Udai Marg,Tilak Nagar -302004
Jaipur
RAJASTHAN |
0141-2623900
dramarjeetmehta@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institue of Medical Sciences |
Approved |
| Ethivcs Commiittee Maulana Azad Medical College |
Approved |
| Post Graduate Institute of Medical Sciences Ram Manohar Lohia Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Initial episode of steroid sensitive nephrotic syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo |
following prednisolone given at 2 mg/kg/day for 6 weeks and 1.5 mg/kg on alternate days for 6 weeks, placebo shall be given at 1 mg/kg on alternate days for 4 weeks, then 0.75 mg/kg on alternate days for 4 weeks, and then 0.5 mg/kg on alternate days for 4 weeks |
| Intervention |
prednisolone |
2 mg/kg/day for 6 weeks, then 1.5 mg/kg on alternate days for 6 weeks, then 1 mg/kg on alternate days for 4 weeks, then 0.75 mg/kg on alternate days for 4 weeks, and then 0.5 mg/kg on alternate days for 4 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with idiopathic, steroid sensitive nephrotic syndrome
2. First episode of nephrotic syndrome
3. Age 1 to 12 years |
|
| ExclusionCriteria |
| Details |
1. Nephrotic syndrome known to be secondary to a systemic disorder, e.g., IgA nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, amyloidosis, hepatitis B antigenemia and Alport syndrome.
2. Patients with impaired renal functions (serum creatinine > 1.2 mg/dl, confirmed within 2 weeks)
3. Patients who have received oral prednisolone, in the past for nephrotic syndrome
4. Patients who have taken prednisolone in the past 4 weeks, in a dose more than 1 mg/kg for >10 days for any other reason
5. Unclear treatment history.
6. Patients staying more than 100 km from the Institute or those not willing to come for clinic visits every two months
7. Gross hematuria
8. Patients with initial steroid resistance
9. Patients who show relapse within the first 3 months of therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The occurrence of relapse during one year follow up, in patients receiving 6 months versus 3 months of prednisolone therapy for the initial episode of nephrotic syndrome |
one year after cessation of therapy with prednisolone |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1) The time to first relapse (days) after discontinuation of initial treatment
2) The proportion of patients with frequent relapses at 1 year, after discontinuation of initial therapy
3) The cumulative prednisolone requirement (mg/kg/day) at 1 year
4) The use of alternative medications, e.g., levamisole, cyclophosphamide, calcineurin inhibitors at 1 year
5) Side effects of corticosteroids (as defined in the protocol) at the end of initial therapy, 1 year
|
One year after cessation of intervention |
|
Target Sample Size
Modification(s)
|
Total Sample Size="168"
Sample Size from India="168"
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)
Modification(s)
|
02/07/2010 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/07/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, parallel group, multicentric trial comparing the safety and efficacy of therapy of initial episode of nephrotic syndrome with prednisolone for three months versus six months, following standard therapy with prednisolone for three months, patients will receive either prednisolone or placebo in tapering doses on alternate days for three months. The study shall be conducted at one center in India. The primary outcome measure is the comparison of relapse rates in the two groups of patients over the next one year, while secondary outcomes include the time to first relapse (in days) after discontinuation of initial treatment, the proportion of patients with frequent relapses at 1 year & 2 years of follow up, the cumulative prednisolone requirement (mg/kg/day) at 1 year, the use of alternative medications at 1 year, and the side effects of corticosteroids at the end of initial therapy and at 1 year. |