Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe University of Queensland
About this trial
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
Qualifiers
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
Disqualifiers
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
Liver enzymes (ALT, AST or Total Bilirubin) >2 times the upper limit of normal, except when a diagnosis of Gilbert Syndrome exists and/or,
Trial design
Treatments tested in this trial
- Metformin XR
- Control
Treatment groups
1,174 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov