ClinicaliQ Trial Snapshot
- Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD) — Recruiting • Phase III • Diabetes / Metabolic • NCT04939935.
- 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….
- Sponsor: The University of Queensland.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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 Snapshot
- : 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 160 mmHg and/or diastolic BP >100 mmHg after a period of rest) 3. Clinically significant heart failure, including but not limited to New York Heart Association Class (NYHA) III or IV 4. Non-polycystic liver disease, including but not limited to: 1. Liver enzymes (ALT, AST or Total Bilirubin) >2 times the upper limit of normal, except when a diagnosis of Gilbert Syndrome exists and/or, 2. Child-Pugh classification score equal to or greater than 5 5. Any contraindication to metformin including abnormal liver function tests or untreated Vitamin B12 deficiency 6. Currently taking metformin 7. Pregnancy or breastfeeding, or planning to get pregnant in the next three years. 8. Comorbidities with potential to contaminate trial outcomes, specifically active cancer, history of other solid organ transplantations, active chronic obstructive pulmonary disease (COPD), active inflammatory…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.