CTRI/2025/09/095042
Not yet recruiting
Not Applicable
Efficacy and safety of tolvaptan in oral furosemide refractory edema in Nephrotic Syndrome : a prospective interventional trial
APC PGIMER1 site in 1 country33 target enrollmentStarted: September 30, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- APC PGIMER
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Urine output over 48 hours (ml/kg/hr) after adding Tolvaptan
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 5.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •children with nephrotic syndrome with moderate to severe oedema.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Urine output over 48 hours (ml/kg/hr) after adding Tolvaptan
Time Frame: 48 hours after intervention
Secondary Outcomes
- 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)
Investigators
Shailza Mahajan
PGIMER
Study Sites (1)
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