AB Rd, near L.I.G Square, Rss Nagar, Indore, Madhya Pradesh 452008 Indore MADHYA PRADESH
9926375627
ishatiwaridoc@gmail.com
Dr Sakshi Jain
Charak Hospital and Research Centre
Room 408, Clinical Research Unit, Charak Hospital and Research Centre
Hardoi Road, Dubagga, Lucknow
U.P. 226003, India Lucknow UTTAR PRADESH
8795278389
Sakshi151@gmail.com
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
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
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
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"
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.