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Recruiting Phase 3 NCT04939935

Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)

Trial Parameters

Condition Autosomal Dominant Polycystic Kidney Disease
Sponsor The University of Queensland
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,174
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2022-11-29
Completion 2026-12
Interventions
Metformin XRControl

Brief Summary

This study will investigate if a medication (metformin) widely used in the treatment of diabetes could be re-purposed for the treatment of patients with a diagnosis of early stage ADPKD to slow the rate of kidney function decline, reducing morbidity and mortality and improving the quality of life for ADPKD patients.

Eligibility Criteria

Inclusion Criteria: To be eligible to participate in this trial, patients must satisfy all of the following inclusion criteria: 1. Willing to participate and provide informed consent 2. Aged 18-70 years 3. Diagnosis of ADPKD based on radiological +/- genetic criteria as per Kidney Health Australia - Caring for Australians and New Zealanders with Kidney Impairment (KHA-CARI) Guidelines 4. eGFR equal to or greater than 38 mL/min/1.73m2 and \<90 mL/min/1.73m2 And have either: 5(a) One or more risk factors of progression from the following: * Bilateral kidney length equal to or greater than16.5 cm, or * Total Kidney Volume (TKV) equal to or greater than 750 mL or height-adjusted TKV (htTKV) equal to or greater than 600 mL/m2, or * Mayo class IC/D/E or Pro-PKD score equal to or greater than 6 OR 5(b) Evidence of Active progression * Decline in eGFR equal to or greater than 5 mL/min/1.73m2 in one year, or * Decline in eGFR equal to or greater than 3 mL/min/1.73m2 per year over five years or

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