Health TrialsbyHealthPanel

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

ConditionAutosomal Dominant Polycystic Kidney Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe University of Queensland

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin XR

    Drug

    Extended release metformin.

  • Control

    Other intervention

    Placebo is inactive tablets that is identical to the intervention Metformin tablets.

Treatment groups

1,174 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The change in estimated glomerular filtration rate (eGFR)

This will be measured using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at 104 weeks (24 months) from first dispensing date.

Time frame
Over 24 months

Secondary outcomes

1

Annualised slope of eGFR.

The mean rate of change in eGFR from baseline over 2 years, estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula from the serum creatinine concentration analysed in the central laboratory.

Time frame
Over 24 months
2

Composite outcome

A composite outcome comprising a reduction from baseline eGFR of equal to or greater than 30%, kidney failure (defined as an eGFR \<15 millilitres/min/1.73m2), and all-cause mortality.

Time frame
Over 24 months
3

Severity of change in eGFR

The proportion of participants with a reduction from baseline in their eGFR of equal to or greater than 30%.

Time frame
Over 24 months
4

Kidney failure

The proportion of participants who experience kidney failure, defined as an eGFR \<15mL/min/1.73m2.

Time frame
Over 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Queensland

Lead sponsor

Source ClinicalTrials.gov
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