| CTRI Number |
CTRI/2024/12/078098 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Delaying initiation of steroid therapy in steroid sensitive nephrotic syndrome children with relapse to reduce steroid therapy usage |
|
Scientific Title of Study
|
Defining relapse with asymptomatic seven-day nephrotic range proteinuria in steroid sensitive nephrotic syndrome to reduce steroid therapy usage: a prospective interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Paraselli Saiteja |
| Designation |
Senior resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
DM Pediatric nephrology,
Department of Pediatrics,
Mother and child building,
AIIMS, New Delhi
South West DELHI 110029 India |
| Phone |
7358521328 |
| Fax |
|
| Email |
saiteja255835@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Pankaj Hari |
| Designation |
Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room No 806,
Division of Pediatric Nephrology,
Department of Pediatrics,
Mother and child building,
AIIMS, New Delhi.
South West DELHI 110029 India |
| Phone |
9560701175 |
| Fax |
|
| Email |
drpankaj.hari@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Paraselli Saiteja |
| Designation |
Senior resident |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
DM Pediatric Nephrology
Department of Pediatrics
Mother and child building
AIIMS, New Delhi
South West DELHI 110029 India |
| Phone |
7358521328 |
| Fax |
|
| Email |
saiteja255835@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar, South west Delhi, 110029, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Paraselli Saiteja |
AIIMS Pediatric nephrology unit |
Pediatric emergency, Pediatric OPD- 2nd floor RAK building, Pediatric ward- 4c, MCB building, Department of pediatrics, Ansari nagar, South west Delhi, 110029, India South West DELHI |
7358521328
saiteja255835@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N049||Nephrotic syndrome with unspecified morphologic changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delaying steroid therapy in relapse of nephrotic syndrome |
While the relapse in nephrotic syndrome is defined by 3 consecutive days of nephrotic range proteinuria, there is a dearth of evidence to support the same. Some observational studies have reported spontaneous remission in 14-30% of relapses between 4 to 14 days of onset of nephrotic range proteinuria. Treating these children as relapse will over-diagnose frequent relapsing nephrotic syndrome causing unnecessary steroid toxicity and usage of alternate immunosuppressive therapy. This study is being conducted to see the proportion of children in whom steroid usage can be prevented by delaying the therapy till seven days of asymptomatic nephrotic range proteinuria
Child will be started on relapse therapy of 2mg/kg/day of oral prednisolone till remission followed by 1.5mg/kg/day alternate day oral prednisolone for 4 weeks in case of relapse therapy |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Steroid sensitive nephrotic syndrome children aged 3 to 18 years with disease duration of more than 1 year and 3 consecutive days of nephrotic range proteinuria |
|
| ExclusionCriteria |
| Details |
Non adherence to urine protein diary maintenance,
Development of edema within 3 days of onset of nephrotic range proteinuria,
Severe infections mandating stress dose steroids,
Steroid resistant nephrotic syndrome course in the past,
Refusal of consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In children with steroid sensitive nephrotic syndrome (SSNS) aged 3-18 years with 3 days of nephrotic range proteinuria, to estimate the proportion of children in whom steroid therapy is avoided by delaying the diagnosis of relapse till day 7 of asymptomatic nephrotic range proteinuria. |
day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the time to remission |
6 weeks |
| To compare the proportion of children in whom steroid therapy is avoided between infrequent relapsing nephrotic syndrome and frequent relapsing nephrotic syndrome/ steroid dependent nephrotic syndrome |
6 weeks |
| To compare the proportion of children in whom steroid therapy is avoided between proteinuria associated with infections and without infections |
6 weeks |
| To estimate the proportion of children in need for relapse therapy within 6 weeks of onset of proteinuria |
6 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Incidence of nephrotic syndrome in
children varies between 1.2 to 16.9 per lakh, with higher incidence in Asian
children. It is characterized by heavy proteinuria, hypoalbuminemia and
edema. Majority of the children (85-90%) respond to steroid therapy with
complete resolution of proteinuria which is termed as steroid sensitive
nephrotic syndrome (SSNS). Though the outcome of SSNS in satisfactory, 50%
children have a frequent relapsing or steroid dependent course and 3-10% show
late steroid resistance.
Relapse in nephrotic syndrome is
defined as three consecutive days of nephrotic range proteinuria. This
definition is empirical and not backed by any evidence from previous studies.
Frequent relapsing nephrotic syndrome (FRNS) and steroid dependent nephrotic
syndrome (SDNS) are at higher risk of steroid toxicity. In order to reduce the
steroid toxicity, these children would require alternate immunosuppressive
drugs like levamisole, mycophenolate mofetil (MMF), oral cyclophosphamide.
These drugs are associated with serious adverse drug reactions like vasculitis,
gastrointestinal disturbances, transaminitis, leukopenia etc.
Previous observational studies have
reported spontaneous resolution of
proteinuria in 33-50% between 5-10 days of onset of nephrotic range proteinuria. These
studies suggest further waiting against the conventional definition of 3
consecutive days of nephrotic range proteinuria for relapse. Thus, a possible
over diagnosis of FRNS/ SDNS and an unnecessary exposure to higher steroid dose
and other immunosuppressive agents can
be avoided.
Since the natural history of
isolated proteinuria without symptoms in nephrotic syndrome is largely unknown,
there is a need for prospective controlled studies for a more accurate
definition of relapse in nephrotic syndrome. Hence, this study is being
conducted to see if delaying the
diagnosis of relapse till seven-days of asymptomatic nephrotic range proteinuria
will reduce the need for steroid usage in SSNS children with 3 days of
nephrotic range proteinuria. |