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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04939935




Registration number
NCT04939935
Ethics application status
Date submitted
16/06/2021
Date registered
25/06/2021

Titles & IDs
Public title
Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)
Scientific title
Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD): A Randomised Placebo-Controlled Trial
Secondary ID [1] 0 0
AKTN16.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autosomal Dominant Polycystic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Metformin XR
Other interventions - Control

Experimental: Intervention - Participants randomised to the intervention group receive Metformin XR plus standard of care for 104 weeks.

Dosage will depend on individual participant's level of tolerance to Metformin XR as well as their estimated glomerular filtration rate (eGFR). The dosage will be between 500-2000mg/day.

Placebo comparator: Control - Participants randomised to the control group receive placebo plus standard of care for 104 weeks.


Treatment: Drugs: Metformin XR
Extended release metformin.

Other interventions: Control
Placebo is inactive tablets that is identical to the intervention Metformin tablets.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The change in estimated glomerular filtration rate (eGFR)
Timepoint [1] 0 0
Over 24 months
Secondary outcome [1] 0 0
Annualised slope of eGFR.
Timepoint [1] 0 0
Over 24 months
Secondary outcome [2] 0 0
Composite outcome
Timepoint [2] 0 0
Over 24 months
Secondary outcome [3] 0 0
Severity of change in eGFR
Timepoint [3] 0 0
Over 24 months
Secondary outcome [4] 0 0
Kidney failure
Timepoint [4] 0 0
Over 24 months
Secondary outcome [5] 0 0
Mortality
Timepoint [5] 0 0
Over 24 months
Secondary outcome [6] 0 0
Change in medication dosage during the trial
Timepoint [6] 0 0
Over 24 months
Secondary outcome [7] 0 0
Changes in the urine albumin:creatinine ratio
Timepoint [7] 0 0
Over 24 months
Secondary outcome [8] 0 0
Presence and category change of albuminuria
Timepoint [8] 0 0
Over 24 months
Secondary outcome [9] 0 0
Health-related quality of life
Timepoint [9] 0 0
Over 24 months
Secondary outcome [10] 0 0
ADPKD-related pain
Timepoint [10] 0 0
Over 24 months
Secondary outcome [11] 0 0
Gastrointestinal symptoms
Timepoint [11] 0 0
Over 24 months
Secondary outcome [12] 0 0
Presence of study-related events
Timepoint [12] 0 0
Over 24 months
Secondary outcome [13] 0 0
Healthcare utilisation
Timepoint [13] 0 0
Over 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
1174
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Renal Research - Gosford
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Westmead Hospital - Western Sydney Local Health District - Sydney
Recruitment hospital [5] 0 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [6] 0 0
Townsville University Hospital - Douglas
Recruitment hospital [7] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [11] 0 0
Austin Health - Melbourne
Recruitment hospital [12] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2050 - Sydney
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
4670 - Bundaberg
Recruitment postcode(s) [6] 0 0
4814 - Douglas
Recruitment postcode(s) [7] 0 0
4006 - Herston
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3052 - Melbourne
Recruitment postcode(s) [11] 0 0
3084 - Melbourne
Recruitment postcode(s) [12] 0 0
3168 - Melbourne
Recruitment postcode(s) [13] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Bay Of Plenty
Country [2] 0 0
New Zealand
State/province [2] 0 0
Northland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Otago

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Mallett, MBBS, PhD
Address 0 0
Townsville University Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Misa Matsuyama, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 437 759 894
Fax 0 0
Email 0 0
impedepkd@uq.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04939935