Using Metformin to Slow Kidney Decline in Polycystic Kidney Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of metformin, a medication commonly used for diabetes, to slow the decline of kidney function in patients with early-stage Autosomal Dominant Polycystic Kidney Disease (ADPKD). The study aims to recruit 1,174 adult participants globally, including 250 from Australia, and will assess the effectiveness of metformin in reducing kidney function decline and improving quality of life. Participants will be randomly assigned to receive either metformin or a placebo, and the outcomes will provide insights into potential new therapies for ADPKD. The trial is designed to address the significant unmet need for effective and affordable treatments for this condition.

Why it matters

Who can join: the full rules

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 more. or
* Increase in htTKV/TKV of equal to or greater than 5% per year on at least 2 measurements in the past year, excluding any initial eGFR effect over the initial 3 months of tolvaptan commencement (if applicable) Note: Tolvaptan therapy must have been in place for at least 6 months with stable dose for at least 3 months.

Exclusion Criteria:

1. Diabetes mellitus (as per American Diabetes Association definition), or other systemic conditions that may cause CKD independent of PKD (excluding hypertension)
2. Uncontrolled hypertension (Systolic BP \>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 bowel disease, and the presence of stoma.
9. History of dialysis.

Where it's running

• Te Whatu Ora - Hauora a Toi Bay of Plenty
  Tauranga, Bay of Plenty, New Zealand Recruiting
• Te Whatu Ora - Te Tai Tokerau
  Whangārei, Northland, New Zealand Recruiting
• Te Whatu Ora - Southern
  Dunedin, Otago, New Zealand Recruiting
• Te Whatu Ora - Taranaki
  New Plymouth, Taranaki Region, New Zealand Recruiting
• Ta Pae Hauora o Ruhahine o Terarua Mid Central
  Palmerston North, New Zealand Recruiting
• Royal Devon & Exeter Hospital
  Exeter, Devon, United Kingdom Recruiting

Study contacts

• Principal investigator: Andrew Mallett, MBBS, PhD — Townsville University Hospital
• Study coordinator: Misa Matsuyama, PhD
• Email: impedepkd@uq.edu.au
• Phone: +61 437 759 894

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Managing Depressive Symptoms in ADPKD: testing Digital Neurotherapy and Capacity Coaching

  This study tests whether Digital Neurotherapy or Capacity Coaching can help people with ADPKD who have depression and self-reported pain, compared to education alone.

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• AZD1613 safety and how the body handles it in adults with ADPKD

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• Intravenous ABBV-CLS-628 for adults with autosomal dominant polycystic kidney disease

  This trial will test whether intravenous ABBV-CLS-628 given every 4 weeks is safe and helps adults with ADPKD.

  Recruiting at 72 sites Phase 2 Calico Life Sciences LLC · Birmingham, Alabama and 90 other locations · NCT06902558

• National Registry for Rare Kidney Diseases

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• Evaluating biomarkers in early autosomal dominant polycystic kidney disease

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• Understanding oxidative stress in patients with Autosomal Dominant Polycystic Kidney Disease

  This study is testing how oxidative stress affects young adults with Autosomal Dominant Polycystic Kidney Disease to find better ways to treat the condition.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT04344769

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.