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Recruiting Phase 3

The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect

NCT06058585 · tracked via the Priya Life Science India tracker
Phase
Phase 3
Started
2024-09-04
Last updated
2026-10-05

Condition(s) studied

Chronic Kidney Diseases

Investigational drug(s) / intervention(s)

Finerenone →Placebo FinerenoneSemaglutide →Placebo semaglutide

Finerenone: Finerenone 10mg or 20mg tablets, oral, once daily

Placebo Finerenone: Finerenone matched placebo tablets, oral, once daily

Semaglutide: Semaglutide 1.0mg or 2.4mg pen injector, subcutaneous injection, once weekly

Placebo semaglutide: Semaglutide matched pen injector, subcutaneous injection, once weekly

Study summary

CAPTIVATE is an international, multi-centre, Phase III, adaptive, platform, randomised controlled trial in people with chronic kidney disease (CKD).

CAPTIVATE aims to find the best treatment, or combination of treatments, that slow the progression of CKD so that fewer people develop kidney failure.

CAPTIVATE provides a research platform that allows many treatment-related questions to be answered within a common trial set-up.

CAPTIVATE includes multiple domains examining different therapies for CKD. Participants may enrol in one or more domains and domains will be added and closed over time. The platform operates under a core protocol with each domain described in a domain specific appendix.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years 2. Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2) 3. Currently receiving standard of care treatment according to treating physician 4. Eligible for randomisation in at least one recruiting domain-specific appendix 5. Participant and treating physician are willing and able to perform trial procedures Exclusion Criteria: 1. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months 2. Life expectancy less than 6 months To be included in any of the following DOMAINS the participant must met eligible for the PLATFORM (as listed above) MRA domain Inclusion Criteria: 1. Urine albumin-creatinine ratio (uACR) \>200 mg/g (22.6 mg/mmol) or urine protein-creatinine ratio (uPCR) \>300 mg/g (33.9 mg/mmol) at time of screening. 2. 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. 3. Treating physician believes finerenone is clinically appropriate for the participant. 4. Participant and treating physician are willing and able to perform MRA DSA procedures. 5. Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any MRA DSA related procedures Exclusion Criteria: 1. Recipient of kidney transplant 2. Hyperkalaemia (serum potassium ≥5.0 mmol/L) at time of screening 3. Current treatment with MRA, where the treating physician or patient is not willing to discontinue this medication. If willing to discontinue the MRA, the potential participant must be re-screened after they have been on stable standard of care treatment for 4 weeks without the MRA. 4. Known allergy, intolerance or contraindication to MRAs 5. Current treatment with strong CYP3A4 inhibitors 6. Systolic BP \<110 mmHg or diastolic BP\<55 mmHg without antihypertensive therapy at time of screening 7. Severe hepatic impairment (defined as Child-Pugh Class C) 8. Adrenal insufficiency 9. Currently pregnant or breast feeding, or intending to become pregnant GLP-1 RA Domain Inclusion Criteria 1. Urine albumin-creatinine ratio (uACR) \>200 mg/g (22.6 mg/mmol) or urine proteincreatinine ratio (uPCR) \>300 mg/g (33.9 mg/mmol) at time of screening. 2. On a stable standard of care treatment for CKD, including a SGLT2i and maximum tolerated ACEi/ARB unless there is a documented reason not to be using a SGLT2i, for 4 weeks before screening. 3. HbA1c less than or equal to 10% (less than or equal to 86mmol/L) 4. BMI ≥23 kg/m2 and \< 50 kg/m2 5. Treating physician believes semaglutide is clinically appropriate for the participant 6. Participant and treating physician are willing and able to perform GLP-1 RA DSA procedures 7. Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any GLP-1 RA DSA related procedures Exclusion Criteria 1. Recipient of kidney transplant 2. Major adverse cardiovascular events (MACE), consisting of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death, within 90 days prior to the day of screening 3. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure 4. Personal or first-degree relative(s) with a history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) 5. Previous episode of pancreatitis 6. Uncontrolled thyroid disease TSH\>6.0 mIU/L or \<0.4mlU/L 7. Type 1 diabetes 8. Current treatment with a GLP-1 RA, where it is in the participant's best interests to continue the GLP-1 RA or where the treating physician or patient is not willing to discontinue this medication for a minimum of 4 weeks prior to randomisation and for the full duration of the trial (ie. 108 weeks if assigned to placebo). 9. Known allergy, intolerance, or contraindication to GLP-1 RAs 10. Currently pregnant or breast feeding, or intending to become pregnant or is of child-bearing potential, and not using a highly effective contraceptive method 11. Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Primary outcome measure(s)

  • Core Primary Outcome Measure — From randomisation to week 108
    The primary outcome is chronic eGFR slope. Chronic eGFR slope measures the rate of eGFR decline while on treatment. The duration of time over which chronic eGFR slope is computed can vary by domain and is determined by clinical considerations such as whether the investigational product can cause an acute decline in eGFR upon initiation. DSAs will specify the duration of time over which chronic eGFR slope is computed for the individual domain.
  • MRA Domain Primary Outcome Measure — From week 4 to week 108
    Chronic eGFR slope estimated from all available eGFR values from week 4 to the end of treatment. The final eGFR value that contributes to the primary outcome is the last eGFR measured while the participant is on treatment.
  • GLP1-RA Domain Primary Outcome Measure — From week 0 to week 108
    Chronic eGFR slope estimated from all available eGFR values from Week 0 to the end of treatment. The final eGFR value that contributes to the primary outcome is the last eGFR measured while the participant is on treatment.

Trial sites (51)

FacilityCityRegionStatus
The Canberra Hospital Garran Australian Capital Territory Recruiting
Nepean Blue Mountains Local Health District Kingswood New South Wales Recruiting
St George Hospital Kogarah New South Wales Recruiting
John Hunter Hospital New Lambton Heights New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Sunshine Coast Hospital and Health Service Birtinya Queensland Recruiting
Townsville University Hospital Douglas Queensland Recruiting
West Moreton Hospital & Health Service Ipswich Queensland Recruiting
Gold Coast Hospital and Health Service Southport Queensland Recruiting
Royal Adelaide Adelaide South Australia Recruiting
Lyell McEwin Hospital Elizabeth Vale South Australia Recruiting
Austin Health Heidelberg Victoria Recruiting
South Metropolitan Health Service, Fiona Stanley Hospital Murdoch Western Australia Recruiting
Gitam Institute of Medical Sciences and Research Visakhapatnam Andhra Pradesh Recruiting
Patna Medical College and Hospital Patna Bihar Recruiting
DKS Super Speciality Hospital, Raipur Raipur Chhattisgarh Recruiting
Mysore Medical College Dehradun Dehradun Recruiting
GCS Medical College, Hospital & Research Centre Ahmedabad Gujarat Recruiting
Aman Hospital & Research Center Vadodara Vadodara Gujarat Recruiting
Father Muller Medical College Hospital Mangaluru Karnataka Recruiting
Dr Moopen's Medical College Meppādi Kerala Recruiting
CARE-CHL Hospital Indore Madhya Pradesh Recruiting
Medway Hospital Chennai Tamil Nadu Recruiting
Yashoda Hospital Hitec City Hyderabad Telangana Recruiting
Apollo Hospitals Hyderabad Telangana Recruiting
Charak Hospital and Research Centre Lucknow Uttar Pradesh Recruiting
Shri Guru Ram Rai Medical College and Shri Mahant Indiresh Hospital Dehradun Uttarakhand Recruiting
Fortis Hospital Kolkata West Bengal Recruiting
North Bengal Medical College & Hospital Siliguri West Bengal Recruiting
Max Superspeciality Hospital, Dehradun Dehradun India Not Yet Recruiting
Max Superspecialty Hospital, Ghaziabad Ghaziabad India Recruiting
Aarupadai Veedu Medical College & Hospital (AVMCH), Puducherry Puducherry India Recruiting
Health New Zealand, Te Whatu Ora Te Matau a Maui, Hawke's Bay Hospital Hastings Hawkes Bay Recruiting
Health New Zealand, Te Whatu Ora Waitemata, North Shore Hospital Auckland New Zealand Recruiting
Auckland City Hospital Auckland New Zealand Recruiting
Aotearoa Clinical Trials Trust, Middlemore Hospital Auckland New Zealand Recruiting
201 Great King Street, Central Dunedin, Dunedin 9016, New Zealand Dunedin New Zealand Recruiting
Midcentral - Palmerston North Hospital Palmerston North New Zealand Recruiting
Private Bag 9742 Maunu Road, Horahora, Whangārei 0148, New Zealand Whangarei New Zealand Recruiting
Hospital Germans Trias i Pujol Badalona Barcelona Active Not Recruiting

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06058585 on ClinicalTrials.gov ↗ ← All trials in India