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Effect of Spironolactone in Acute kidney disease

Effect of spironolactone on renal outcome in acute kidney disease: an open label randomised controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/023081
Enrollment
34
Registered
2020-01-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N178- Other acute kidney failure

Interventions

Intervention1: Spironolactone: Spironolactone will be started at a dose of 25 mg once daily and increased to 50 mg once daily at 4 weeks,provided the serum potassium is no more than 4.5 mmol/l.The do

Sponsors

Government of West Bengal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of Acute Kidney Disease, defined as patients with serum creatinine >1.5 times the baseline or egfr

Exclusion criteria

Exclusion criteria: Patients unable to provide informed or surrogate consent Patients with serum potassium >4.5 Females who are pregnant ,lactating or unwilling to use contraception. Patients who are hypotensive with BP Patients with any absolute or relative contraindication for doing renal biopsy. Patients with acute GN diagnosed clinically or by biopsy. Patients with Clinically significant urinary tract obstruction , confirmed by imaging. Patients with history of allergy to spironolactone. Patients with history of any malignancy.

Design outcomes

Primary

MeasureTime frame
Percentage change in estimated glomerular filtration rate in the study group compared to control group. Timepoint: Percentage change in estimated glomerular filtration rate in the study group compared to control group at 0 and 6 months

Secondary

MeasureTime frame
Change in mean blood pressure and antihypertensive requirement between baseline and 6 months. Timepoint: 0 and 6 months;Percentage Change in proteinuria as compared to baseline. Timepoint: 0 and 6 months;Percentage Change in renal fibrosis as measured by trichrome staining of renal biopsy tissues scored by two pathologists independently.Timepoint: 0 and 6 months;Rate of serious adverse events (resulting in death or nonelective hospitalization)Timepoint: 6 months

Countries

India

Contacts

Public ContactSyed Mubashir Nissar

Institute of Post Graduate Medical Education and Research

deepsircar@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026