RecruitingPhase 3

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

Australia1,174 participantsStarted 2022-11-29

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Willing to participate and provide informed consent
✓. Aged 18-70 years
✓. 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
✓. eGFR equal to or greater than 38 mL/min/1.73m2 and \<90 mL/min/1.73m2

Exclusion criteria

✕. Diabetes mellitus (as per American Diabetes Association definition), or other systemic conditions that may cause CKD independent of PKD (excluding hypertension)
✕. Uncontrolled hypertension (Systolic BP \>160 mmHg and/or diastolic BP \>100 mmHg after a period of rest)
✕. Clinically significant heart failure, including but not limited to New York Heart Association Class (NYHA) III or IV
✕. Non-polycystic liver disease, including but not limited to:
✕. Liver enzymes (ALT, AST or Total Bilirubin) \>2 times the upper limit of normal, except when a diagnosis of Gilbert Syndrome exists and/or,
✕. Child-Pugh classification score equal to or greater than 5
✕. Any contraindication to metformin including abnormal liver function tests or untreated Vitamin B12 deficiency
✕. Currently taking metformin

What they're measuring

The change in estimated glomerular filtration rate (eGFR)

Timeframe: Over 24 months

Trial details

NCT IDNCT04939935

SponsorThe University of Queensland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12

Contact for this trial

Misa Matsuyama, PhD

+61 437 759 894 impedepkd@uq.edu.au

View on ClinicalTrials.gov More Autosomal Dominant Polycystic Kidney Disease trials