Autosomal Dominant Polycystic Kidney Disease study: Metformin XR
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?
An investigational extended‑release oral medication being studied for early stage Autosomal Dominant Polycystic Kidney Disease (ADPKD). It is designed to lower blood sugar by reducing glucose production in the liver and increasing insulin sensitivity.
Also referred to as Metformin.
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
- The study aims to see if metformin, a drug normally used for diabetes, can reduce how quickly kidney function worsens in early ADPKD patients.
- Who it's for
- Adults diagnosed with early stage autosomal dominant polycystic kidney disease.
- What's involved
- Participants will take metformin and have regular check‑ups and kidney function tests to monitor progress.
- Time commitment
- The trial lasts about 3 years, with visits every few months to track kidney health and medication safety.
- 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...
- Bilateral kidney length equal to or greater than16.5 cm, or
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
- 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
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
- 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
- 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 is enrolling
- 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
- Salford, Lancashire, United Kingdom
- Leicester, Leicestershire, United Kingdom
- Liverpool, Merseyside, United Kingdom
- Antrim, Northern Ireland, United Kingdom
- Belfast, Northern Ireland, United Kingdom
- Londonderry, Northern Ireland, United Kingdom
- Oxford, Oxfordshire, United Kingdom
- Doncaster, South Yorkshire, United Kingdom
- Sheffield, South Yorkshire, United Kingdom
- Bradford, West Yorkshire, United Kingdom
- Cardiff, United Kingdom
- Carshalton, United Kingdom
- London, United Kingdom
- Nottingham, United Kingdom
+ 4 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, but 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?
This study is enrolling now at 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 and 18 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.