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Comparison of Metformin therapy with Placebo therapy on progression of disease in the patients with Autosomal Dominant Polycystic Kidney Disease.

Effect of Metformin therapy on progression of Autosomal Dominant Polycystic Kidney Disease: an open label 2: 1 randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069541
Enrollment
108
Registered
2024-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: Q612- Polycystic kidney, adult type

Interventions

Intervention1: Metformin : tablet Metformin at 1gm twice a day par orally for 12 months Control Intervention1: Placebo: Similar looking Vitamin B tablets with Vitamin B12 750 microgram twice a day pa

Sponsors

IPGMER and SSKM hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with ADPKD defined as per case definition between 18-65 years 2. eGFR > 45 ml/min/1.73 m2 as per CKD EPI 2021 equation. 3. Typical or Class 1 ADPKD on MRI.

Exclusion criteria

Exclusion criteria: 1. Patients with Diabetes mellitus. 2. Patients with liver disease (elevation of liver enzymes >2 times the baseline). 3. Females who were pregnant or breast feeding or unwilling to use contraception. 4. Congestive heart failure, 5. Unable to undergo MR imaging. 6. Subjects those were taking medications that interact with metformin like digoxin, quinidine, cimetidine. 7. Known hypersensitivity to metformin and its derivatives. 8. Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study. 9. HIV, HBV, HCV infection. 10. Urinary tract obstruction. 11. Atypical Type 2 ADPKD on MRI

Design outcomes

Primary

MeasureTime frame
percentage change in Height adjusted total kidney volume by MRITimepoint: 1 year

Secondary

MeasureTime frame
Percentage change in estimated Glomerular Filtration rateTimepoint: 12 months

Countries

India

Contacts

Public ContactAniruddha Datta

Department of Nephrology, Institute of Post Graduate Medical Education & Research

lahiri.arpi@gmail.com9433254601

Outcome results

None listed

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