What is metformin studying for Autosomal Dominant Polycystic Kidney Disease (ADPKD)?

Metformin is being studied to see if it can slow the decline in kidney function in people with ADPKD. Researchers want to find an affordable and effective treatment to reduce disease impact and improve quality of life. This trial is led by The University of Queensland as a global Phase III study.

Who may be eligible for this Autosomal Dominant Polycystic Kidney Disease clinical trial?

Adults aged 18 to 70 years with a diagnosis of ADPKD and kidney function (eGFR) between 38 and 90 mL/min/1.73m2 may be eligible. Participants should also have certain risk factors for disease progression and must not have diabetes or be currently taking metformin. Please review eligibility criteria for more details.

Is there any cost to participate in this Autosomal Dominant Polycystic Kidney Disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 3

Age: 18Years - 70Years

All Genders

ID04939935

Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease IMPEDE-PKD A Randomised Placebo-Controlled Trial

Led by The University of Queensland · Updated on 2026-03-31

1174

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether metformin, a medication commonly used for diabetes, can be repurposed to slow kidney function decline in adults diagnosed with early-stage Autosomal Dominant Polycystic Kidney Disease ADPKD. ADPKD causes cyst growth in kidneys leading to pain, high blood pressure, chronic kidney disease, and reduced quality of life. This global Phase III randomized controlled trial aims to find effective, affordable treatments to reduce illness impact and improve life quality for ADPKD patients. Participants are randomly assigned to receive either extended-release metformin Metformin XR or a placebo, alongside standard care, for 104 weeks. The metformin dose ranges from 500 to 2000 mg daily based on individual tolerance and kidney function. The study includes a control group receiving identical placebo tablets for comparison. This design allows assessment of metformins effect on slowing disease progression. During the study, participants undergo regular monitoring including kidney function tests, assessment of kidney disease progression, quality of life questionnaires, and tracking of side effects and healthcare use over 24 months. The primary outcome is the change in estimated glomerular filtration rate eGFR. Secondary outcomes include kidney failure, mortality, medication dosing changes, and symptoms related to ADPKD. Safety and effectiveness are carefully followed throughout the trial period, which may last until 2030.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years

All Genders

Eligibility Criteria

You may qualify if you...

Willing to participate and provide informed consent
Aged 18 to 70 years
Diagnosis of Autosomal Dominant Polycystic Kidney Disease based on radiological or genetic criteria
Estimated glomerular filtration rate (eGFR) between 38 and 90 mL/min/1.73m2
Presence of one or more risk factors such as kidney length at least 16.5 cm, total kidney volume at least 750 mL, height-adjusted total kidney volume at least 600 mL/m2, Mayo classification IC/D/E, or Pro-PKD score of 6 or higher
Evidence of active progression shown by decline in eGFR or increase in kidney volume over time with specified thresholds
Stable tolvaptan therapy if applicable, with at least 6 months use and stable dose for 3 months

You will not qualify if you...

Diagnosis of diabetes mellitus or other systemic conditions causing chronic kidney disease independent of polycystic kidney disease (except hypertension)
Uncontrolled hypertension (systolic blood pressure over 160 mmHg or diastolic over 100 mmHg after rest)
Clinically significant heart failure including New York Heart Association Class III or IV
Non-polycystic liver disease with liver enzymes more than twice normal or Child-Pugh score of 5 or higher
Contraindications to metformin such as abnormal liver tests or untreated vitamin B12 deficiency
Current use of metformin
Pregnancy, breastfeeding, or planning pregnancy within 3 years
Other serious conditions affecting trial outcomes such as active cancer, organ transplant history, active COPD, inflammatory bowel disease, or presence of stoma
History of dialysis

Research Team

Misa Matsuyama, PhD

Pushparaj Velayudham

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