Chronic Kidney DiseasesPhase 3CAPTIVATENCT06058585
The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect
A Phase 3 study testing Finerenone and Semaglutide in people with Chronic Kidney Diseases, run by The George Institute at 51 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Finerenone and Semaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 51 sitesin 5 countries
- Study dates
- 4 Sep 2024to 31 Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Known chronic kidney disease from any cause (eGFR ≥25 mL/min/1.73m2)
- Currently receiving standard of care treatment according to treating physician
- Eligible for randomisation in at least one recruiting domain-specific appendix
- Participant and treating physician are willing and able to perform trial procedures
- 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.
Show all 17Show fewer
- 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.
- Treating physician believes finerenone is clinically appropriate for the participant.
- Participant and treating physician are willing and able to perform MRA DSA procedures.
- Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any MRA DSA related procedures
- 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.
- 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.
- HbA1c less than or equal to 10% (less than or equal to 86mmol/L)
- BMI ≥23 kg/m2 and < 50 kg/m2
- Treating physician believes semaglutide is clinically appropriate for the participant
- Participant and treating physician are willing and able to perform GLP-1 RA DSA procedures
- Provision of written informed consent or eConsent following a fully informed discussion and prior to performing any GLP-1 RA DSA related procedures
Who cannot join
- Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
- 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
- Recipient of kidney transplant
- Hyperkalaemia (serum potassium ≥5.0 mmol/L) at time of screening
Show all 25Show fewer
- 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.
- Known allergy, intolerance or contraindication to MRAs
- Current treatment with strong CYP3A4 inhibitors
- Systolic BP <110 mmHg or diastolic BP<55 mmHg without antihypertensive therapy at time of screening
- Severe hepatic impairment (defined as Child-Pugh Class C)
- Adrenal insufficiency
- Currently pregnant or breast feeding, or intending to become pregnant
- GLP-1 RA Domain
- Recipient of kidney transplant
- 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
- Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
- Personal or first-degree relative(s) with a history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC)
- Previous episode of pancreatitis
- Uncontrolled thyroid disease TSH>6.0 mIU/L or <0.4mlU/L
- Type 1 diabetes
- 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).
- Known allergy, intolerance, or contraindication to GLP-1 RAs
- Currently pregnant or breast feeding, or intending to become pregnant or is of child-bearing potential, and not using a highly effective contraceptive method
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Trial locations and contacts
51 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
51 sites in 5 countries
India19 sites, 19 recruiting
- Recruiting
GCS Medical College, Hospital & Research Centre
Ahmedabad, Gujarat, 380025
Suvika Patel
- Recruiting
Medway Hospital
Chennai, Tamil Nadu, 600024
Shivakumar Dakshinamoorthy
- Recruiting
Mysore Medical College
Dehradun, Dehradun, 248001
Puneet Arora
- Recruiting
Shri Guru Ram Rai Medical College and Shri Mahant Indiresh Hospital
Dehradun, Uttarakhand, 248001
Gaurav Shekhar Sharma
- Not yet recruiting
Max Superspeciality Hospital, Dehradun
Dehradun, 248001
Puneet Arora
- Recruiting
Max Superspecialty Hospital, Ghaziabad
Ghaziabad, 201012
Manoj Kumar Singhal
- Recruiting
Yashoda Hospital Hitec City
Hyderabad, Telangana, 500084
Mahesh Kota
- Recruiting
Apollo Hospitals
Hyderabad, Telangana
Haresh Patel
- Recruiting
CARE-CHL Hospital
Indore, Madhya Pradesh
Isha Tiiwari
- Recruiting
Fortis Hospital
Kolkata, West Bengal, 700107
Upal Sengupta
- Recruiting
Charak Hospital and Research Centre
Lucknow, Uttar Pradesh, 226003
Sakshi Jain
- Recruiting
Father Muller Medical College Hospital
Mangaluru, Karnataka, 575002
Manjunath Kulkarni
- Recruiting
Dr Moopen's Medical College
Meppādi, Kerala, 673511
Aneesh Basheer
- Recruiting
Patna Medical College and Hospital
Patna, Bihar, 800001
Harsh Vardhan
- Recruiting
Aarupadai Veedu Medical College & Hospital (AVMCH), Puducherry
Puducherry, 607403
Venkatesh A
- Recruiting
DKS Super Speciality Hospital, Raipur
Raipur, Chhattisgarh, 492002
Varun Agrawal
- Recruiting
North Bengal Medical College & Hospital
Siliguri, West Bengal, 734012
Arpita Ray Chaudhury
- Recruiting
Aman Hospital & Research Center Vadodara
Vadodara, Gujarat, 390007
Aman Khanna
- Recruiting
Gitam Institute of Medical Sciences and Research
Visakhapatnam, Andhra Pradesh, 530045
Murty Mandapaka
Australia13 sites, 13 recruiting
- Recruiting
Royal Adelaide
Adelaide, South Australia, 5000
Michael Collins
- Recruiting
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, 4575
Nicholas Gray
- Recruiting
Townsville University Hospital
Douglas, Queensland, 4814
Vikas Srivastava
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Nitesh Rao
- Recruiting
The Canberra Hospital
Garran, Australian Capital Territory, 2605
Girish Talaulikar
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Sharon Ford
- Recruiting
West Moreton Hospital & Health Service
Ipswich, Queensland, 4305
Sree Venuthurupalli
- Recruiting
Nepean Blue Mountains Local Health District
Kingswood, New South Wales, 2747
Bhadran Bose
- Recruiting
St George Hospital
Kogarah, New South Wales, 2217
Sunil Badve
- Recruiting
South Metropolitan Health Service, Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Suda Swaminathan
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Bobby Chacko
- Recruiting
Gold Coast Hospital and Health Service
Southport, Queensland, 4215
Jagadeesh Kurtkoti
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Vincent Lee
Sri Lanka9 sites, 9 recruiting
- Recruiting
National Nephrology Specialized Hospital
Colombo, Polonnaruwa, 51000
Dr Naseef Thaseem
- Recruiting
National Hospital of Sri Lanka
Colombo, 00700
Dr Mathu Selvarajah
- Recruiting
University Hospital, Kotelawala Defence University
Dehiwala, Western Province, 10290
Dr Dilukshi Pilapitiya
- Recruiting
Jaffna Teaching Hospital
Jaffna, Northern Province, 4000
Dr. Brammah Thangarajah
- Recruiting
Kandy National Hospital
Kandy, 20000
Dr Nishantha Nanayakkara
- Recruiting
Kurunegala Teaching Hospital
Kurunegala
Dr Premil Rajakrishnan
- Recruiting
Sri Jayewardenepura General Hospital
Nugegoda, 10250
Dr Harshani Perera
- Recruiting
Peradeniya Teaching Hospital
Peradeniya, 20400
Dr Rajitha Abeysekera
- Recruiting
Colombo North Teaching Hospital
Ragama, 11010
Dr Nalaka Herath
New Zealand7 sites, 7 recruiting
- Recruiting
Health New Zealand, Te Whatu Ora Waitemata, North Shore Hospital
Auckland, 0620
Ashik Hayat
- Recruiting
Auckland City Hospital
Auckland, 1023
Dr Helen Pilmore
- Recruiting
Aotearoa Clinical Trials Trust, Middlemore Hospital
Auckland, 2025
Kalpa Jayanatha
- Recruiting
201 Great King Street, Central Dunedin, Dunedin 9016, New Zealand
Dunedin, 9016
John Schollum
- Recruiting
Health New Zealand, Te Whatu Ora Te Matau a Maui, Hawke's Bay Hospital
Hastings, Hawkes Bay, 4120
Hussain Allawati
- Recruiting
Midcentral - Palmerston North Hospital
Palmerston North, 4442
Dr Curtis Walker
- Recruiting
Private Bag 9742 Maunu Road, Horahora, Whangārei 0148, New Zealand
Whangarei, 0148
Adam Mullan
Spain3 sites, 2 recruiting
- Active, not recruiting
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
- Recruiting
Vall d'Hebron University Hospital
Horta-Guinardó, Barcelona, 08035
Dr Maria Jose Soler Romeo
- Recruiting
Hospital Clinico Universitario València (INCLIVA)
Valencia, Espana, 46010
Prof Jose Luis Gorriz Teruel
About this study
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.
Read the detailed description
Chronic kidney disease (CKD) affects over 800 million people globally and is projected to be the 5th most common cause of death by 2040. CKD progresses to kidney failure, increases the risk of early death, heart disease, and leads to a poorer quality of life.
Current treatments do not entirely remove the risk of kidney failure in people with CKD. To improve the outcomes of people with CKD, it is crucial to find the best treatment or combination of treatments that can slow CKD progression. CAPTIVATE aims to address this need.
CAPTIVATE has been designed to test multiple treatments within a common research platform. This design is more efficient and will lead to a shorter time for patients to receive effective treatments. The trial is 'eternal', which means that participants will continue to be recruited for many years until the trial is finally wound up. It is also 'adaptive', providing the flexibility to add new treatments, or remove those that are not working.
Participants can participate in more than one treatment at the same time or at different times. Participants receive each study treatment for 2 years. For each treatment, participants are followed up at study visits that occur at approximately one month, 3 months, 6 months, 12 months, 18 months and 2 years after starting treatment. A final study visit occurs one month after the end of the 2-year treatment phase. Information collected at study visits include blood and urine test results, safety assessments and treatment adherence. Information about the overall health status of each participant is collected every 5 years.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Finerenone, Placebo Finerenone, Semaglutide, Placebo semaglutide
- Keywords
- Chronic kidney disease, Mineralocorticoid Receptor Antagonist, Finerenone, Semaglutide, Glucagon-like peptide-1 receptor agonist
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Also called BAY94-8862
Finerenone 10mg or 20mg tablets, oral, once daily
Placebo FinerenoneDrug
Finerenone matched placebo tablets, oral, once daily
SemaglutideDrug
Semaglutide 1.0mg or 2.4mg pen injector, subcutaneous injection, once weekly
Placebo semaglutideDrug
Semaglutide matched pen injector, subcutaneous injection, once weekly
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Finerenone 10mg or 20mg tablets Receives: Drug: Finerenone |
| Placebo Finerenone | Placebo comparator | Finerenone matched placebo tablets Receives: Drug: Placebo Finerenone |
| Semaglutide | Experimental | Semaglutide 1.0 mg or 2.4 mg pen injector Receives: Drug: Semaglutide |
| Placebo Semaglutide | Placebo comparator | Semaglutide matched placebo pen injector Receives: Drug: Placebo semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Primary Outcome Measure
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.
Measured: From randomisation to week 108
MRA Domain Primary Outcome Measure
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.
Measured: From week 4 to week 108
GLP1-RA Domain Primary Outcome Measure
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.
Measured: From week 0 to week 108
Secondary outcomes (22)
Core Protocol Secondary outcomes
- Change in albuminuria as measured by uACR (or uPCR if uACR unavailable) between week 0 and 24 weeks, measured as a continuous variable.
Measured: week 0 and 24 weeks
Core Protocol Secondary outcomes
- eGFR slope from week 0 to end of washout
Measured: week 0 to end of washout
Core Protocol Secondary outcomes
- Change in eGFR from week 0 to end of washout
Measured: week 0 to end of washout
Core Protocol Secondary outcomes
- Composite outcome of proportion of participants experiencing a ≥40% eGFR decline between week 0 and 108 weeks, and proportion of participants developing kidney failure (defined as eGFR <15 mL/min/1.73m2 or chronic kidney replacement therapy start†) at 108 weeks.
Measured: between week 0 and 108 weeks
Core Protocol Secondary outcomes
- Time to a composite outcome of ≥40% eGFR decline from week 0 or kidney failure
Measured: from start of study drug (week 0) to washout (week 108) or kidney failure
Core Protocol Secondary outcomes
- All-cause mortality at 108 weeks
Measured: at 108 weeks
Core Protocol Secondary outcomes
- Proportion of participants experiencing one or more cardiovascular events (cardiovascular death, hospitalised heart failure, myocardial infarction, stroke)* between week 0 and week 108
Measured: between week 0 and week 108
Core Protocol Secondary outcomes
- Time to first occurrence of a cardiovascular event
Measured: from start of study drug (week 0) to end of washout (week 108)
Core Protocol Secondary outcomes
- Safety and tolerability of treatment
Measured: from start of study drug (week 0) to end of treatment (up to week 104)
Core Protocol Secondary outcomes
- Change in quality of life measured using the Quality of Life Impact Survey for Kidney Disease (QDISCKD) at 6-monthly intervals from randomisation to week 108.
Measured: 6-monthly intervals from randomisation to week 108
MRA Domain Secondary Outcome
MRA DSA has a domain-specific secondary outcome that evaluates the time to the composite of ≥57% eGFR decline from week 0 or kidney failure
Measured: from start of study drug (week 0) to end of washout (week 108)
GLP-1 RA Domain Secondary Outcome
- Change in eGFR slope from Week 0 to Week 108.
Measured: from start of study drug (week 0) to end of washout (week 108)
GLP-1 RA Domain Secondary Outcome
- Time to composite of onset of kidney failure (initiation of long-term dialysis, kidney transplantation, or a reduction in the eGFR to <15 mL per minute per 1.73 m2 sustained for ≥28 days), a sustained (for ≥28 days) 50% or greater reduction in eGFR from Week 0, or death from kidney-related or cardiovascular causes.
Measured: from start of study drug (week 0) to end of washout (week 108)
GLP-1 RA Domain Secondary Outcome
- Time to first occurrence of onset of persistent ≥50% reduction in eGFR from Week 0 to Week 108
Measured: from Week 0 to Week 108
GLP-1 RA Domain Secondary Outcome
- Time to first occurrence of a composite outcome of major adverse cardiovascular events (MACE) consisting of non-fatal myocardial infarction, non-fatal stroke, or cardiovascular death
Measured: from start of study drug (week 0) to end of washout (week 108)
GLP-1 RA Domain Secondary Outcome
- Time to occurrence of all-cause death
Measured: from start of study drug (week 0) to end of washout (week 108)
GLP-1 RA Domain Secondary Outcome
- Change in body weight from Week 0 to Week 108
Measured: from Week 0 to Week 108
GLP-1 RA Domain Secondary Outcome
- Change in HbA1c from Week 0 to Week 108
Measured: Week 0 to Week 108
GLP-1 RA Domain Secondary Outcome
- Change in systolic blood/diastolic blood pressure from Week 0 to Week 108
Measured: from Week 0 to Week 108
GLP-1 RA Domain Secondary Outcome
- Change in NT-proBNP from Week 0 to Week 108
Measured: from Week 0 to Week 108
GLP-1 RA Domain Secondary Outcome
- Change in health status measured using the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ) at 6-monthly intervals from randomisation to Week 108
Measured: from randomisation to Week 108
GLP-1 RA Domain Secondary Outcome
- Incidence of AEs and the following medical events of special interest (MESI) from Week 0 to end of trial:
- Neoplasm (malignant and benign)
- Pancreatitis, or persistent abdominal pain leading to a suspicion of pancreatitis
- Acute gallstone disease (biliary colic or acute cholecystitis)
- Thyroid disease
- Cardiac arrhythmia (specifically, atrial fibrillation, atrial flutter, ventricular tachycardia, ventricular fibrillation, torsade de pointes, second degree heart block type 2, third degree heart block, and symptomatic bradycardia requiring pacemaker placement)
- Severe hypoglycaemic episodes
- Immunogenicity events (allergic reactions, immune-complex disease, and lack of efficacy)
- Adverse events leading to treatment discontinuation (if not any of the mentioned MESIs)
- Ocular adverse events
- Suspicion of transmission of infectious agents
Measured: Week 0 to end of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start4 Sep 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Adaptive platform trial evaluating multiple interventions in multiple domains of therapeutic care. Additional interventions and participants will be added as the trial grows.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sradha Kotwal, Study chair, The George InstituteHiddo Lambers Heerspink, Study chair, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058585
- Sponsor's protocol ID
- P01351
- Other IDs
- U1111-1324-3113
- Acronym
- CAPTIVATE
- Status last verified
- Aug 2026
- First submitted
- 21 Sep 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Trial data will be made available as a resource for future unspecified research, subject to any prior contractual obligations. Researchers wishing to gain access to the study resources will be required to submit an application for review by the Platform Oversight Committee, including a detailed project description, a list of data requested, and evidence of ethical approval. De-identified data extracts will be made available to approved proposals, and will not include data obtained from data linkage with local registries.
Publications
Yeung EK, Rangaswami J, Tuttle KR, Grams ME, Tangri N, Vaduganathan M, Neuen BL. A Framework for Risk-Based Implementation of Combination Therapy in CKD: Who, Why, When, and How? Clin J Am Soc Nephrol. 2026 Jun 23. doi: 10.2215/CJN.0000001158. Online ahead of print.
PubMed 42335037Shah NA, Du R, Neuen BL, Levin A, Jha V, Heerspink HJL, Kotwal SS; CAPTIVATE investigators. A Dose of Perspective: A Multinational Survey of Patient and Clinician Views on Combination Therapy in CKD. Kidney360. 2026 Aug 1;7(8):1772-1780. doi: 10.34067/KID.0000001227. Epub 2026 Jun 2.
PubMed 42228487Kotwal SS, Perkovic V, Jardine MJ, Kim D, Shah NA, Lin E, Coggan S, Billot L, Vart P, Wheeler DC, de Boer IH, Zhang H, Hou FF, Sugawara Y, Marion J, Lewis RJ, Berry LR, McGlothlin A, Jha V, De Nicola L, Gorriz JL, Heerspink HJL; GKPTN and CAPTIVATE Investigators. The Global Kidney Patient Trials Network and the CAPTIVATE Platform Clinical Trial Design: A Trial Protocol. JAMA Netw Open. 2024 Dec 2;7(12):e2449998. doi: 10.1001/jamanetworkopen.2024.49998.
PubMed 39661388Heerspink HJL, Kretzler M. Clinical Trials for Kidney Disease in the Era of Personalized Medicine. J Am Soc Nephrol. 2024 Aug 1;35(8):1123-1126. doi: 10.1681/ASN.0000000000000412. Epub 2024 May 9. No abstract available.
PubMed 39248631