| CTRI Number |
CTRI/2025/09/095042 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study safety of Tolvaptan for management of swelling in children with Nephrotic Syndrome who did not respond to Furosemide |
|
Scientific Title of Study
|
Efficacy and safety of tolvaptan in oral furosemide refractory edema in Nephrotic Syndrome : a prospective interventional 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 |
Shailza Mahajan |
| Designation |
Senior Resident |
| Affiliation |
PGIMER |
| Address |
Unit- Pediatric Nephrology
Room Number- 4110
Advanced Pediatric Centre,
PGIMER,
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9465863631 |
| Fax |
|
| Email |
drshailzamahajan35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karalanglin Tiewsoh |
| Designation |
Additional Professor |
| Affiliation |
PGIMER |
| Address |
Pediatric Nephrology
Room Number- 4110
APC
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9465863631 |
| Fax |
|
| Email |
ktiewsoh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shailza Mahajan |
| Designation |
Senior Resident |
| Affiliation |
PGIMER |
| Address |
Pediatric Nephrology
Room No- 4110
APC, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9465863631 |
| Fax |
|
| Email |
drshailzamahajan35@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER
Sector 12
Chandigarh
Pincode-160012
Country - India |
|
|
Primary Sponsor
|
| Name |
APC PGIMER |
| Address |
PGIMER,
Sector 12, Chandigarh
PIN code- 160012
Country- 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 Shailza Mahajan |
Advanced Pediatrics Centre, PGIMER |
Pediatric Nephrology
Room Number- 4110
Advanced Pediatric Centre,
PGIMER
Chandigarh
CHANDIGARH |
9465863631
drshailzamahajan35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PGIMER |
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 |
| Comparator Agent |
nil |
nil |
| Intervention |
Tolvaptan |
Tolavaptan will be given as once daily dose for 2 days ( total doses- 2)
Weight till 15kg- 7.5mg per oral , once daily
Weight 15 to 30kg- 15mg per oral, once daily
Weight more than 30 kg- 30mg per oral, once daily |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
children with nephrotic syndrome with moderate to severe oedema |
|
| ExclusionCriteria |
| Details |
Hypovolemia, CSVT, sodium less than 125 or more than 140, eGFR less than 60, SGOT and SGPT more than 2 times upper normal limit, other diuretics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Urine output over 48 hours (ml/kg/hr) after adding Tolvaptan |
48 hours after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage weight loss over the first 48 hours of combination therapy |
48 hours |
| Urine and serum osmolality before and every 24 hours of therapy |
48 hours |
| Serum copeptin levels before and after the tolvaptan therapy |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
30/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In children 5-14 years of age diagnosed with nephrotic syndrome, having moderate to severe oedema, fulfilling the inclusions and exclusion criteria will be enrolled in the study. All the participants will be given 2-4mg/kg/day of furosemide. The children who have weight loss <3% of baseline body weight after 24 hours of oral furosemide will be considered furosemide refractory. In these children tolvaptan will be added with furosemide for next 48 hours. Children will be evaluated for urine output and percentage weight loss over 48 hours after adding tolvaptan. |