| CTRI Number |
CTRI/2024/07/070629 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of tapering of steroid treatment over 4 weeks versus 8 weeks in children with frequently relapsing nephrotic syndrome |
|
Scientific Title of Study
|
Comparison of the efficacy of steroid tapering over 4-weeks with 8-weeks in children with frequently relapsing or steroid dependent nephrotic syndrome on a steroid-sparing agent presenting with a relapse - A non-inferiority randomised controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ria Ann Philip |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education And Research (JIPMER) |
| Address |
Department of Paediatrics, 2nd floor, Women and Child block, JIPMER, Dhanvantari Nagar, Puducherry- 605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9080998929 |
| Fax |
|
| Email |
riaannphilip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudarsan K |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education And Research JIPMER |
| Address |
Department of Paediatrics, 2nd floor, Women and Child Hospital, JIPMER, Dhanvantari Nagar, Puducherry- 605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9855071507 |
| Fax |
|
| Email |
sudarsanjipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudarsan K |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Post graduate Medical Education And Research JIPMER |
| Address |
Department of Paediatrics, 2nd floor, Women and Child Hospital, JIPMER, Dhanvantari Nagar, Puducherry- 605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9855071507 |
| Fax |
|
| Email |
sudarsanjipmer@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural research fund,
JIPMER Puducherry, Gorimedu, Pondicherry- 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Post Graduate Medical Education and research JIPMER |
| Address |
Dhanavantri Nagar, Puducherry- 605006
India |
| 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 |
| Dr Ria Ann Philip |
JIPMER jawaharlal institute of post graduate medical education and research |
Paediatric nephrology clinic, Department of Paediatrics, Women and Children block, JIPMER, Dhanvantari nagar, Puducherry
Pondicherry
PONDICHERRY |
9080998929
riaannphilip@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institutional Ethics comittee- interventional studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quick weekly tapering of steroids over 4 weeks |
After standard treatment of relapse with daily prednisolone 2 mg/kg (max 60 mg) till remission followed by 4 weeks of alternate day prednisolone 1.5 mg/kg (max 40 mg), patients who are randomised to the intervention group will undergo quick tapering of steroids over 4 weeks i.e. 1 mg/kg for one week, 0.75 mg/kg for one week, 0.5 mg/kg for one week, 0.25 mg/kg for one week and then prednisolone will be stopped |
| Comparator Agent |
Standard 2 weekly tapering of steroids over 8 weeks |
After standard treatment of relapse with daily prednisolone 2 mg/kg (max 60 mg) till remission followed by 4 weeks of alternate day prednisolone 1.5 mg/kg (max 40 mg), patients who are randomised to the control group will undergo standard tapering of steroids over 8 weeks i.e. 1 mg/kg for two weeks, 0.75 mg/kg for two weeks, 0.5 mg/kg for two weeks, 0.25 mg/kg for two weeks and then prednisolone will be stopped |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children 1-18 years of age with frequently relapsing or steroid dependent nephrotic syndrome on a steroid-sparing agent (levamisole/ mycophenolate mofetil/calcineurin inhibitor) for the preceding 2 months
Presenting with relapse
|
|
| ExclusionCriteria |
| Details |
Children currently on/have received oral cyclophosphamide in the preceding 6 months
Children currently on/have received rituximab in the preceding 6 months
Children who do not achieve remission even after 6 weeks of prednisolone treatment for the current relapse (late steroid resistance)
Infantile onset nephrotic syndrome, monogenic and secondary forms of nephrotic syndrome (lupus nephritis, membranous nephropathy, etc.)
Patients with significant comorbidities like diabetes (type 1 or drug induced), glaucoma, avascular necrosis of hip, psychosis, etc.
Patient already enrolled in the study will not be re-enrolled in a future relapse
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence rate of relapses during the 6-months follow-up period |
6 months post randomization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence rate of relapses at 12-months post randomization
Incidence rate of upper respiratory tract infection (URI)-triggered relapses at 6-months and 12-months post randomization
Time to first relapse
Time to treatment failure
Sustained remission
Cumulative steroid dose (in mg/kg)
Steroid-related adverse events
hsCRP levels (at enrolment and follow-up) |
monthly follow up for 12 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
25/07/2024 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study shall be undertaken at the Dept of Paediatrics, JIPMER from July 2024 for a period of 2 years after acquiring the Institutional Ethics Committee (IEC) clearance and CTRI registration prior to enrolment of the first patient. This study shall include patients aged 1 to 18 years with frequently relapsing or steroid dependent nephrotic syndrome who are on a steroid sparing agent for the preceding 2 months. When these patients present with a relapse, they will be approached for possible enrolment into the trial. Written informed consent will be taken from the parents of the study participants (and assent from children 8 years or older) and the study will be conducted in accordance with the Declaration of Helsinki. Once patients are enrolled, the weight of the child will be recorded with an electronic weighing machine with a precision of 10 g. The height will be recorded with the help of a manual stadiometer with a precision of 0.1 cm. The dose of prednisolone calculated according to the body weight will be rounded off to the nearest multiple of 2.5. Prednisolone will be administered in the form of tablets (minimal strength 5 mg), which can be broken into half, if required. They will receive standard treatment for relapse i.e. daily prednisolone at 2 mg/kg (maximum 60 mg) till remission followed by 1.5 mg/kg (maximum 40 mg) alternate day prednisolone for 4 weeks. Subsequently, they will be randomised to one of the two arms (intervention vs control group) and the steroid treatment in each of these arms will be as per the mentioned protocol. The cumulative steroid dose will be calculated in mg/kg. All patients will also receive the steroid-sparing agent they were already on, apart from calcium supplements. The dose of the steroid-sparing agents will be as per the prevailing standard of care in the unit, which is in line with the ISPN 2022 guidelines. Subsequently, all enrolled patients will be followed up monthly for the next 6 months for the primary outcome and 12 months for the secondary outcome. During each follow-up visit, medications will be checked (pill count) and further medications for the next 30 days will be given. The urine protein diary monitored by the patients at home will be checked and the details entered in a predesigned proforma. Patients will undergo spot urinary protein dipstick and urine spot protein-creatinine ratio in each monthly visit and blood tests for CBC, albumin, creatinine, cholesterol once in 3 months; hsCRP will be checked at enrollment and at 6 months. Eye check up for cataract and glaucoma will be checked at baseline and at 6 months.
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