Comparison of Metformin therapy with Placebo therapy on progression of disease in the patients with Autosomal Dominant Polycystic Kidney Disease.
- Conditions
- Health Condition 1: Q612- Polycystic kidney, adult type
- Registration Number
- CTRI/2024/06/069541
- Lead Sponsor
- IPGMER and SSKM hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method percentage change in Height adjusted total kidney volume by MRITimepoint: 1 year
- Secondary Outcome Measures
Name Time Method Percentage change in estimated Glomerular Filtration rateTimepoint: 12 months