A clinical trial to study effect of a drug metformin in slowing progression of autosomal dominant polycystic kidney disease

Phase 3

• Conditions: Health Condition 1: Q612- Polycystic kidney, adult type

• Registration Number: CTRI/2022/05/042904
• Lead Sponsor: Post Graduate Institute of Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Diagnosis of ADPKD based on updated ravine criteria

2.eGFR >= 45 ml/min/1.73 m2

3.Controlled blood pressure < 130/80 on a stable regimen of antihypertensive drugs

Exclusion Criteria

1. ADPKD patients who fulfill the criteria of likely rapid disease progression at baseline ( kidney length >=16.5 cm, as assessed by ultrasound (or MRI) in patients younger than 50 years , PRO-PKD score > 6, Mayo class 1C, D, E)

2. Diabetes mellitus (as defined by American Diabetes Association consensus criteria)

3. Intolerance to metformin

4. Uncontrolled hypertension

5. Pregnancy / Lactation

6. Systemic diseases which contribute to renal disease other than hypertension

7. Acute or chronic disease causing tissue hypoxia (e.g.: myocardial failure, severe arrhythmia, myocardial infarction, respiratory failure, liver failure, alcohol acute intoxication, alcoholism, dehydration).

8. Systemic infection

9. Essential drugs with drug interactions with metformin including nifedipine and furosemide

Study & Design

• Study Type: Interventional
• Study Design: Not specified