| CTRI Number |
CTRI/2018/07/015143 [Registered on: 31/07/2018] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trial to compare the effectiveness of two different drugs for the treatment of children with nephrotic syndrome. |
|
Scientific Title of Study
|
Randomized controlled trial to compare the efficacy of daily Levamisole versus Mycophenolate mofetil therapy in children with frequently relapsing or 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 |
Kamran Afzal |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical College, A.M.U, Aligarh
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
571-2721182 |
| Fax |
|
| Email |
drkafzal@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamran Afzal |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical College, A.M.U, Aligarh
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
571-2721182 |
| Fax |
|
| Email |
drkafzal@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyotsana Singh |
| Designation |
Trainee Pediatrics Resident |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical College, A.M.U, Aligarh
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
571-2421583 |
| Fax |
|
| Email |
singhjyotsana22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, A.M.U, Aligarh |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Department of Pediatrics,
Jawaharlal Nehru Medical College
A.M.U, Aligarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kamran Afzal |
Jawaharlal Nehru Medical College, AMU, Aligarh |
Pediatric Nephrology Clinic, Ward # 17, Jawaharlal Nehru Medical College, A.M.U
Aligarh
UTTAR PRADESH |
571-2721182
drkafzal@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levamisole |
2.5 mg/kg/day for 1 year |
| Comparator Agent |
Mycophenolate mofetil |
1000 mg/sq.m for 1 year |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Two or more relapses in 6 months while on alternate day levamisole with tapering alternate day prednisolone therapy, or
2. If the prednisolone threshold to maintain remission exceeds 0.7 mg/kg on alternate days or,
3. Patients have significant steroid toxicity (cushingoid with hypertension, ocular toxicity such as cataract, glaucoma or an episode of serious life threatening infection). |
|
| ExclusionCriteria |
| Details |
1.Age at onset of nephrotic syndrome less than 1 year or more than 10 year.
2. History of use of alternative treatment other than alternate day levamisole.
3. Biopsy showing pathology other than MCNS.
4. Secondary nephrotic syndrome.
5. Late steroid resistance.
6. Residing >100 km from centre or unwilling to follow up. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relapse frequency |
At enrolment, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Side effects
Time to first relapse
Proportion of patients relapse-free
Cumulative steroid dose used
Failure of the trial medication in either group |
During 1 year follow up period |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2018 |
| Date of Study Completion (India) |
06/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Children with steroid sensitive nephrotic syndrome often have a frequently relapsing or steroid dependent disease. Such patients are put on alternate day tapering prednisolone or alternative medications. However, there is no standard protocol regarding choice of alternative drugs in children with frequently relapsing or steroid dependent nephrotic syndrome. Recent trials have demonstrated the superiority of daily levamisole over alternate day therapy. Daily levamisole has been shown to be effective in at least half the cases who had failed on alternate day levamisole. Based on these observations we hypothesized that daily levamisole therapy could potentially have efficacy to match MMF therapy. There is no trial directly comparing MMF and levamisole in the management of steroid dependent or frequently relapsing nephrotic syndrome in children. Both drugs help in tapering the dose of corticosteroids, thereby reducing the side effects of steroids. Both the drugs have to be given for prolonged periods and both have been shown to be relatively safe in children on long-term use. However, levamisole is a considerably cheaper alternative as compared to MMF, thereby making it an attractive treatment option in resource constrained countries. Although there is very little evidence on which drug is more efficacious in preventing relapses in children with nephrotic syndrome, MMF is generally considered as a superior agent than levamisole given as alternate day treatment. In this randomized controlled trial we aim to test the therapeutic efficacy of levamisole administered in a daily dose of 2.5 mg/kg/d versus mycophenlate mofetil for a duration of 9 to12 months, in children with frequently relapsing or steroid dependent nephrotic syndrome. We hypothesize that daily levamisole in a dose of 2.5 mg/kg/day, may not be significantly inferior to daily mycophenolate mofetil treatment given in a dose of 1000 mg/m2. The primary objective of the study is to compare changes in relapse frequency at baseline and study end (i.e. after 1 year of treatment). Secondary objectives are to compare safety (side effects), time to first relapse, proportion of patients relapse-free, cumulative steroid dose used and failure of the trial medication. |