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New treatment option for Autosomal Dominant Polycystic Kidney Disease
Official title Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)
ClinicalTrials.gov ID: NCT04939935
What this study is testing
What is Metformin XR?
Metformin XR is an investigational medicine, being studied as a potential treatment for autosomal dominant polycystic kidney disease.
Also referred to as APO-Metformin XR (500mg).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- To be eligible to participate in this trial, patients must satisfy all of the following
- 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...
- 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...
You likely can't join if
- Diabetes mellitus (as per American Diabetes Association definition), or other systemic conditions that may cause CKD independent of PKD (excluding...
- 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
See the full eligibility criteria
- To be eligible to participate in this trial, patients must satisfy all of the following
- 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 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...
- 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
- Pregnancy or breastfeeding, or planning to get pregnant in the next three years.
- 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...
- History of dialysis.
The study team makes the final eligibility decision.
Where it's taking place
- Gosford, New South Wales, Australia
- Sydney, New South Wales, Australia
- Bundaberg, Queensland, Australia
- Douglas, Queensland, Australia
- Herston, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Tauranga, Bay of Plenty, New Zealand
- Whangārei, Northland, New Zealand
- Dunedin, Otago, New Zealand
- New Plymouth, Taranaki Region, New Zealand
- Palmerston North, New Zealand
- Exeter, Devon, United Kingdom
- Nottingham, East Midlands, United Kingdom
- Inverness, Inverness Shire, United Kingdom
- Preston, Lancashire, United Kingdom
- Salford, Lancashire, United Kingdom
- Leicester, Leicestershire, United Kingdom
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gosford, New South Wales, Australia; Sydney, New South Wales, Australia; Bundaberg, Queensland, Australia; Douglas, Queensland, Australia; Herston, Queensland, Australia; Woolloongabba, Queensland, Australia and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.