AB Rd, near L.I.G Square, Rss Nagar, Indore, Madhya Pradesh 452008 Indore MADHYA PRADESH
9131304253
arpitneema53@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 Varun Agrawal
DKS Super Speciality Hospital
OPD no. 01, Department of nephrology, OPD block, DKS speciality hospital, Ghadi chowk, Raipur, Chhattisgarh-492002, India
Raipur CHHATTISGARH
7869354494
varunagrawal87@gmail.com
Dr Sreelakshami
Dr Moopens Medical College
Room no. 2, 6th floor, Department of Nephrology, Wayanad, Kerala 673577 Wayanad KERALA
9400854412
drsreelakshmi16@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 Manik Kataruka
Fortis Hospital
Room 205, Department of Nephrology, Fortis Hospital, 730, Eastern Metropolitan Bypass, Anandapur, East Kolkata Twp, Kolkata, West Bengal 700107 Kolkata WEST BENGAL
9592916778
mkworld80@gmail.com
Dr Suvika Patel
GCS Medical College, Hospital & Research Centre
Room No 105, 1st Floor, Nephrology OPD, Opp DRM office, Nr. Chamunda bridge, Naroda Road, Ahmedabad , Gujarat 380025
Ahmadabad GUJARAT
9824044482
suvikapatel.nephro@gmail.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 Neeru P Aggarwal
Max Superspeciality Hospital Vaishali
W-2 and W-3, Ashok Marg, near Radisson Blu Hotel, Sector-1, Vaishali, Ghaziabad, Uttar Pradesh 201012 Ghaziabad UTTAR PRADESH
9810266275
neerupaggarwal@gmail.com
Dr Rajeevalochana
Medway Hospitals
2, 26, 1st Main Rd, United India Colony, Kodambakkam, Chennai, Tamil Nadu 600024 Chennai TAMIL NADU
9535271897
jeevssri@gmail.com
Dr Niranjan MR
Mysore Medical College And Research Institute
Department of Nephrology, 2nd Floor ,Room No. 1 ,MMC&RI- Princess Krishnajammanni Super Speciality Hospital, Oppo. t ESI Hsp. , KRS Rd. ,Mysore Karnataka-570015
Mysore KARNATAKA
9448672501
drniranjanmr@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
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
Age greater than or equal to 18 years.
Known CKD from any cause. eGFR greater than or equal to 25 mL per minute per 1.73 square meter.
Eligible for randomisation in at least one recruiting domain specific appendix.
MRA Domain Specific Inclusion Criteria
On stable CKD treatment including SGLT2 inhibitor unless contraindicated for 4 weeks before screening as per treating physician.
uACR greater than 200 milligrams per gram or 22.6 milligrams per millimole. Alternatively uPCR greater than 300 milligrams per gram or 33.9 milligrams per millimole.
GLP 1 Domain Specific Inclusion Criteria
uACR greater than 200 milligrams per gram or 22.6 milligrams per millimole. Alternatively uPCR greater than 300 milligrams per gram or 33.9 milligrams per millimole.
On stable CKD treatment including SGLT2 inhibitor and maximum tolerated ACE inhibitor or ARB unless contraindicated for 4 weeks before screening.
HbA1c greater than or equal to 10 percent. Equivalent to less than or equal to 86 millimoles per litre.
BMI greater than or equal to 23 kilograms per square meter and less than 50 kilograms per square meter.
ExclusionCriteria
Details
Core Exclusion Criteria
Currently receiving maintenance dialysis.
Planned to commence kidney replacement therapy or kidney transplant surgery within the next 6 months.
Life expectancy less than 6 months.
MRA Domain Exclusion Criteria
Recipient of kidney transplant.
Serum potassium more than 5.0 mmol per litre at screening.
Current treatment with MRA.
Known allergy to MRA.
Treatment with strong CYP3A4 inhibitors.
Systolic blood pressure less than 110 mmHg or diastolic blood pressure less than 55 mmHg without antihypertensive therapy.
Severe hepatic impairment.
Adrenal insufficiency.
Currently pregnant or breastfeeding, or intending to become pregnant.
GLP 1 Domain Exclusion Criteria
Major adverse cardiovascular event consisting of non fatal myocardial infarction, non fatal stroke, or cardiovascular death within 90 days before screening.
Presently classified as New York Heart Association Class IV heart failure.
Personal or first degree relative with a history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
Previous episode of pancreatitis.
Uncontrolled thyroid disease. Thyroid stimulating hormone greater than 6.0 milli international units per litre or less than 0.4 milli international units per litre.
Type 1 diabetes.
Current treatment with a GLP 1 receptor agonist.
Known allergy, intolerance, or contraindication to GLP 1 receptor agonists.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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
Time to composite of onset of kidney failure, initiation of long term dialysis, kidney transplantation, reduction in eGFR to less than 15 mL per minute per 1.73 square metres, sustained 50 percent reduction in eGFR from Week 0, or death from kidney related or cardiovascular causes
Week 0 to Week 108
Time to first occurrence of persistent 50 percent or greater reduction in eGFR.
Week 0 to Week 108
Time to first occurrence of a composite outcome of major adverse cardiovascular events consisting of non fatal myocardial infarction, non fatal stroke, or cardiovascular death
Week 0 to Week 108
Change in body weight
Week 0 to Week 108
Change in HbA1c
Week 0 to Week 108
Change in systolic blood pressure & diastolic blood pressure
Week 0 to Week 108
Change in NT proBNP
Week 0 to Week 108
Change in health status measured using the Kansas City Cardiomyopathy Questionnaire
Every 6 months from Week 0 to Week 108
Incidence of adverse events & medical events of special interest including neoplasms, pancreatitis, gallstone disease, thyroid disease, cardiac arrhythmias, severe hypoglycaemia, immunogenicity events, adverse events leading to treatment discontinuation, ocular adverse events, & suspicion of transmission of infectious agents
Total Sample Size="2000" Sample Size from India="500" 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.