The Chronic kidney disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect (CAPTIVATE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

The George Institute For Global Health

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2024-11-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511325-67-00

ClinicalTrials.gov

NCT06058585

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To determine investigational agents or combinations of agents that reduce the rate of eGFR decline (slow progression of CKD), compared to placebo, in patients with chronic kidney disease receiving standard of care therapy.

Secondary objectives 9

1. 1. Change in albuminuria between randomisation and 24 weeks
2. 2. Proportion of participants experiencing a 40% eGFR decline, and proportion of participants developing kidney failure (defined as eGFR <15 mL/min/1.73m2 or chronic kidney replacement therapy start) at 108 weeks
3. 3. Time to ≥40% eGFR decline from randomisation or kidney failure
4. 4. All-cause mortality at 108 weeks
5. 5. Proportion of participants experiencing one of more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) between randomisation and 108 weeks
6. 6. Time to first occurrence of a cardiovascular event
7. 7. Safety and tolerability of the intervention
8. 8. Change in quality of life measured using the Quality of Life Impact Survey for Kidney Disease (QDIS-CKD) at 6-monthly intervals from randomisation to week 108
9. The Mineralocorticoid Receptor Antagonist Domain-Specific Appendix has a domain specific secondary objective to determine the effect of the interventions on the time to the composite of ≥57% eGFR decline or kidney failure.

Conditions and MedDRA coding

Chronic kidney disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Age ≥ 18 years
2. 2. Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m^2)
3. 3. Currently receiving standard of care treatment according to treating physician
4. 4. Eligible for randomisation in at least one recruiting domain-specific appendix
5. 5. Participant and treating physician are willing and able to perform trial procedures
6. 6. Urine albumin-creatinine ratio (uACR) >200 mg/g or urine protein-creatinine ratio (uPCR) >300 mg/g from the most recent result in the previous 3 months.
7. 7. On a stable standard of care treatment for CKD, including a SGLT2i unless there is a documented reason not to be using a SGLT2i, for 4 weeks before screening according to treating physician.
8. 8. Treating physician believes finerenone is clinically appropriate for the participant.
9. 9. Participant and treating physician are willing and able to perform Mineralocorticoid Receptor Antagonist Domain-Specific Appendix procedures.

Exclusion criteria 12

1. 1. Currently receiving maintenance dialysis
2. 2. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
3. 3. Life expectancy less than 6 months
4. 4. Recipient of kidney transplant
5. 5. Hyperkalaemia (serum potassium ≥5.0 mmol/L) at time of screening
6. 6. Current treatment with mineralocorticoid receptor antagonist (MRA), where the treating physician or patient is not willing to discontinue this medication
7. 7. Known allergy, intolerance or contraindication to MRAs
8. 8. Current treatment with strong CYP3A4 inhibitors
9. 9. Systolic BP <110 mmHg or diastolic BP <55 mmHg without antihypertensive therapy at time of screening
10. 10. Severe hepatic impairment (defined as Child-Pugh Class C)
11. 11. Adrenal insufficiency
12. 12. Currently pregnant or breast feeding, or intending to become pregnant

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. eGFR slope calculated using eGFR values from randomisation to week 108

Secondary endpoints 9

1. 1. Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between randomisation and 24 weeks, measured as a continuous variable
2. 2. Composite outcome of proportion of participants experiencing a 40% eGFR decline between randomisation and 108 weeks, and proportion of participants developing kidney failure (defined as eGFR <15 mL/min/1.73m^2 or chronic kidney replacement therapy start) at 108 weeks
3. 3. Time to a composite outcome of ≥40% eGFR decline from randomisation or kidney failure
4. 4. All-cause mortality at 108 weeks
5. 5. Proportion of participants experiencing one or more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke) between randomisation and 108 weeks
6. 6. Time to first occurrence of a cardiovascular event
7. 7. Safety and tolerability of treatment
8. 8. Change in quality of life measured using the Quality of Life Impact Survey for Kidney Disease (QDIS-CKD) at 6-monthly intervals from randomisation to week 108
9. 9. The Mineralocorticoid Receptor Antagonist Domain-Specific Appendix has a domain-specific secondary outcome of time to the composite of ≥57% eGFR decline or kidney failure.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

The George Institute For Global Health

Sponsor organisation

The George Institute For Global Health

Address

International Tower 3, Level 18 300 Barangaroo Avenue Level 18 300 Barangaroo Avenue

City

Barangaroo

Postcode

2000

Country

Australia

Scientific contact point

Organisation

The George Institute For Global Health

Contact name

Sradha Kotwal

Public contact point

Organisation

The George Institute For Global Health

Contact name

Sradha Kotwal

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications