| CTRI Number |
CTRI/2024/08/072627 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A platform trial exploring the effectiveness of finerenone in patients with Chronic Kidney Disease |
|
Scientific Title of Study
|
The chronic kidney disease adaptive platform trial investigating various agents for therapeutic effects |
| Trial Acronym |
CAPTIVATE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT06058585 |
ClinicalTrials.gov |
| P01351 v2.0 dated 16 Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vivekanand Jha |
| Designation |
Chief Executive Officer |
| Affiliation |
George Institute Services India Pvt Ltd |
| Address |
409, Fourth Floor, Elegance Tower, Plot No. 8, Jasola District Centre, New Delhi 110025
New Delhi
DELHI
110025
India |
| Phone |
8527544733 |
| Fax |
|
| Email |
vjha@george-services.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vivekanand Jha |
| Designation |
Chief Executive Officer |
| Affiliation |
George Institute Services India Pvt Ltd |
| Address |
409, Fourth Floor, Elegance Tower, Plot No. 8, Jasola District Centre, New Delhi 110025
New Delhi
DELHI
110025
India |
| Phone |
8527544733 |
| Fax |
|
| Email |
vjha@george-services.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Bathla |
| Designation |
Project Manager |
| Affiliation |
George Institute Services India Pvt Ltd |
| Address |
311-312, Third Floor, F-BLOCK, Jasola Vihar, New Delhi, Delhi
New Delhi
DELHI
110025
India |
| Phone |
9886926282 |
| Fax |
|
| Email |
nikita.bathla@george-services.com |
|
|
Source of Monetary or Material Support
|
| George Institute for Global Health Australia |
|
|
Primary Sponsor
|
| Name |
George Institute for Global Health Australia |
| Address |
Level 18, International Tower 3, 300 Barangaroo Ave, Sydney NSW 2000, Australia |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| National Health and Medical Research Council Australia |
16 Marcus Clarke St Canberra ACT 2601 |
|
|
Countries of Recruitment
|
Australia
India
Italy
New Zealand |
Sites of Study
Modification(s)
|
| No of Sites = 16 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anand Chellappan |
All India Institute of Medical Sciences |
Room No 426, Nephrology OPD, 4th Floor, AIIMS OPD block, MIHAN, Nagpur, Sumthana, Dahegaon, Maharashtra 441108
Nagpur
MAHARASHTRA |
8903613270
anandchellappan@aiimsnagpur.edu.in |
| Dr Rajesh Kumar |
All India Institute of Medical Sciences, Deogarh |
All India Institute of Medical Sciences, Deoghar, Rampur, Jharkhand 814152
Deoghar
JHARKHAND |
8809663800
drrajeshdr@yahoo.co.in |
| Dr Aneesh Basheer |
Dr Moopens Medical College |
Room no. 2, 6th floor, Department of Nephrology, Wayanad, Kerala 673577
Wayanad
KERALA |
9677154338
basheeraneesh@gmail.com |
| Dr Manjunath Kulkarni |
Father Muller Medical College Hospital |
Father Mullers Rd, Kankanady, Mangaluru, Karnataka 575002
Dakshina Kannada
KARNATAKA |
7795069393
drmjkulkarni@gmail.com |
| Dr Upal Sengupta |
Fortis Hospital |
Room 205, Department of Nephrology, Fortis Hospital, 730, Eastern Metropolitan Bypass, Anandapur, East Kolkata Twp, Kolkata, West Bengal 700107
Kolkata
WEST BENGAL |
9830922466
upalinpgi@gmail.com |
| Dr Gulshan Kumar Mukhiya |
Geetanjali Medical College and Hospital |
Hiranmagri Extension, Manwakhera NH-8 Bypass, Near Eklingpura, Chouraha, Udaipur, Rajasthan 313001
Udaipur
RAJASTHAN |
8233639147
mukhiyag@rediffmail.com |
| Dr Murty Mandapaka |
Gitam Institute of Medical Sciences and Research |
GITAM Medical College Rd, Gandhi Nagar, Rushikonda, Visakhapatnam, Andhra Pradesh 530045
Visakhapatnam
ANDHRA PRADESH |
9619623838
mmandapa@gitam.edu |
| Dr Manoj Kumar Singhal |
Max Superspeciality Hospital |
W-3, Ashok Marg, near Radisson Blu Hotel, Sector-1, Vaishali, Ghaziabad, Uttar Pradesh 201012
Ghaziabad
UTTAR PRADESH |
9811120087
manojsinghal7@gmail.com |
| Dr Shivakumar Dakshinamoorthy |
Medway Hospitals |
2, 26, 1st Main Rd, United India Colony, Kodambakkam, Chennai, Tamil Nadu 600024
Chennai
TAMIL NADU |
9380090973
dshiva1978@gmail.com |
| Dr Arpita Ray Chaudhury |
North Bengal Medical College and Hospital |
Faculty & HOD room, Department of Nephrology, North Bengal Medical College and Hospital, D-5 Quarter Sushruta Nagar, Dist, Siliguri, West Bengal 734012
Darjiling
WEST BENGAL |
9433254601
lahiri.arpi@gmail.com |
| Dr Harsh Vardhan |
Patna Medical College and Hospital |
Ashok Rajpath Rd, Patna University Campus, Patna, Bihar 800001
Patna
BIHAR |
7781913911
hvardhan10@gmail.com |
| Dr Sanjiv Saxena |
Pushpawati Singhania Hospital and Research Institute |
Chairman room, Nephrology department,
A Block, First floor, Press Enclave Marg, J Pocket, Phase II, Sheikh Sarai, New Delhi, Delhi 110017
New Delhi
DELHI |
9810139839
drsanjivsaxena@rediffmail.com |
| Dr Narayan Prasad |
Sanjay Gandhi Postgraduate Institute of Medical Science |
New PMSSY Rd, Raibareli Rd, Lucknow, Uttar Pradesh 226014
Lucknow
UTTAR PRADESH |
9415403140
narayan.nephro@gmail.com |
| Dr Gaurav Shekhar Sharma |
Shri Guru Ram Rai Institute of Medical and Health Sciences and Shri Mahant Indiresh Hospital |
Dehrakhas, Patel Nagar, Dehradun, Uttarakhand 248001
Dehradun
UTTARANCHAL |
9460384265
shekhargaurav2012@gmail.com |
| Dr Geet Bajpai |
Venkateshwar Hospital |
Sector 12 Rd, Sector 18, Sector 18A Dwarka, New Delhi-110075
New Delhi
DELHI |
9999674114
geetbajpai@gmail.com |
| Dr Rajasekara Chakravarthi Madarasu |
Yashoda Hospitals Hitec City |
Room no 114,
First floor, OPD 1,
Yashoda Hospital, Survey No. 41/14, JNTU, to, Hitech City Main Rd, Khanamet Village, Sharilimgampally, Hyderabad, Kothaguda, Telangana 500084
Hyderabad
TELANGANA |
9391059322
rajasekarac@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| DMWIMS Institutional Ethics Committee |
Approved |
| Father Muller Institutional Ethics Committee |
Approved |
| Fortis Hospital Ethics Committee |
Submittted/Under Review |
| Geetanjali Medical College and Hospital |
Approved |
| Gitam Institute of Medical Sciences and Research |
Approved |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee for Clinical Trial AIIMS Nagpur |
Submittted/Under Review |
| Institutional Ethics Committee North Bengal Medical College Darjeeling |
Approved |
| Institutional Ethics Committee, IGIMS ,Sheikhpura |
Submittted/Under Review |
| Institutional Ethics Committee, Max Super Speciality Hospital |
Approved |
| Institutional Ethics Committee, SGPGIMS |
Submittted/Under Review |
| Medway Hospitals Institutional Ethics Committee |
Approved |
| PSRIEC |
Submittted/Under Review |
| Sri Guru Ram Rai Institute of Medical & Health Sciences |
Approved |
| Venkateshwar Hospital |
Approved |
| Yashoda Academy of Medical Education and Research |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Finerenone |
10 mg or 20 mg orally once daily for 2 years |
| Comparator Agent |
Finerenone matched placebo |
Orally once daily for 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Core Inclusion Criteria
1. Age ≥ 18 years
2. Known CKD from any cause (eGFR ≥25 mL/min/1.73m2)
3. Eligible for randomisation in at least one recruiting domain-specific appendix
MRA Domain Specific Inclusion Criteria
1. On stable CKD treatment, including SGLT2i unless contraindicated, for 4 weeks pre-screening per physician.
2. uACR greater than 200mg/g or uPCR greater than 300mg/g
|
|
| ExclusionCriteria |
| Details |
Core Exclusion Criteria
1. Currently receiving maintenance dialysis
2. Planned to commence kidney replacement therapy or kidney transplant surgery in next 6 months
3. Life expectancy less than 6 months
MRA Domain Exclusion Criteria
1. Recipient of kidney transplant
2. S. potassium more than 5.0mmol/L at screening
3. Current treatment with MRA
4. Known allergies to MRAs
5. Treatment with strong CYP3A4 inhibitors
6. SBP less than 110mmHg or DBP less than 55mmHg without antihypertensive therapy
7. Severe hepatic impairment
8. Adrenal insufficiency
9. Currently pregnant or breastfeeding, or intending to become pregnant |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| eGFR slope |
Week 108 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in albuminuria measured as uACR |
Week 24 |
| Composite outcome of proportion of participants experiencing a 40% eGFR decline and proportion of participants experiencing kidney failure |
Week 108 |
| Time to composite outcome of more than 40% eGFR decline |
First occurence |
| All-cause mortality |
Week 108 |
| Proportion of participants experiencing cardiovascular events |
Week 108 |
| Time to first occurence of CV event |
First occurence |
| Change in quality of life |
Week 108 |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Multi-centre, multi-arm, Phase III, placebo-controlled, parallel group, adaptive platform randomised controlled trial in patients with CKD. Participants in CAPTIVATE will be actively followed up for 108 weeks post-randomisation, and passively followed up until death. The primary outcome of eGFR slope will be calculated using values obtained from randomisation to week 108. A pipeline of various therapeutic agents to be studied in the future will be added as domain-specific appendices (DSAs) under the overarching core protocol. Interventions will be evaluated in participants receiving standard of care therapy. DSAs will be implemented in accordance with the core protocol, however, they may have additional characteristics or design features that will be described in the relevant DSA. Participants will be able to participate concurrently and also sequentially in more than one DSA, provided that they meet DSA eligibility criteria. CAPTIVATE is intended to be perpetual and will continue to operate until there are no open DSAs, and no participants in follow up. |