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CTRI Number  CTRI/2024/04/065084 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical trial to evaluate the efficacy, safety and tolerability of FDC of Dapagliflozin 10mg and Telmisartan 80mg in patients with chronic kidney disease 
Scientific Title of Study   A multicentric, randomized, prospective, double blind, parallel group, comparative, active controlled, phase III clinical study to evaluate the efficacy, safety and tolerability of Fixed Dose Combination of Dapagliflozin 10 mg and Telmisartan 80 mg versus concurrent use Dapagliflozin 10mg tablets and Telmisartan 80mg tablets in patients with Chronic Kidney Disease. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ICS/ERI/2023-005 Version 1.0, Date 19 SEP 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Kartik Sahni  
Designation  Director 
Affiliation  Insignia Clinical Services Pvt. Ltd. 
Address  Insignia Clinical Services Pvt Ltd. #512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura

North West
DELHI
110034
India 
Phone  9868679414  
Fax    
Email  kartik.sahni@insigniacs.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Kartik Sahni  
Designation  Director 
Affiliation  Insignia Clinical Services Pvt. Ltd. 
Address  Insignia Clinical Services Pvt Ltd. #512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower Netaji Subhash Place , Pitampura


DELHI
110034
India 
Phone  9868679414  
Fax    
Email  kartik.sahni@insigniacs.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr Ganesh Boddu 
Designation  Head-Clinical and Regulatory Affairs  
Affiliation  Eris Lifesciences Limited 
Address  Eris Lifesciences Limited Opp Swati Bunglow, Shivarth Ambit, Ramdas Road, Thaltej

Ahmadabad
GUJARAT
380059
India 
Phone  7969661401  
Fax    
Email  ganesh.boddu@erislifesciences.com  
 
Source of Monetary or Material Support  
ERIS LIFESCIENCES LIMITED, Opp. Swati Bunglow, Shivarth Ambit, Ramdas Road, Thaltej, Ahmedabad, Gujarat, 380059.  
 
Primary Sponsor  
Name  ERIS LIFESCIENCES LIMITED  
Address  Plot No. 30-31, Brahmaputra Industrial Park, Village-Silla Amingaon, North Guwahati Assam- 781031  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
ERIS LIFESCIENCES LIMITED   Opp. Swati Bunglow, Shivarth Ambit, Ramdas Road, Thaltej, Ahmedabad, Gujarat, 380059. 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 20  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Umesh Dubey  Atmaram Child Care and Critical Care  Department of Nephrology, Room No 03, Ground Floor 53 128 Y Block Naubasta 208011
Kanpur Nagar
UTTAR PRADESH 		 9674487888

dubeydrumesh6@gmail.com 
Dr S Raghavendra   Banu Hospital Unit of PCRI Pvt Ltd   Department of Nephrology 1 53 First Srinagar Chinnapadugupadu Kovur Nellore 524137
Nellore
ANDHRA PRADESH 		 8622256799

raghavendra@pcripl.com 
Dr Vidyasagar Korla  Government Medical College and Government General Hospital  OPD No 13, First Floor, Department of Nephrology Srikakulam 532001 India
Srikakulam
ANDHRA PRADESH 		 9948741133

drvidyasagarkggh@gmail.com 
Dr Anjani Achanta   Great Eastern Medical School and Hospital  Department of Nephrology, Room No 101, Ragolu Srikakulam- 532484
Srikakulam
ANDHRA PRADESH 		 8897307110

dranjaniachanta@gmail.com 
Dr Samir Govil  GSVM Medical College  Post Graduate Department of Medicine Swaroop Nagar 208002
Kanpur Nagar
UTTAR PRADESH 		 9839068111

samirgovil18@gmail.com 
Dr Vipul Vasantrao Chakurkar   KEM Hospital Research Centre  Room No 104 First Floor KEM Hospital Sardar Moodliar Road Rasta Peth Pune 411011
Pune
MAHARASHTRA 		 9403207328

bestvipul@gmail.com 
Dr Dadala Ratna Prabha   King George Hospital  Department of Nephrology Room No 001, Ground Floor Andhra Medical College
Visakhapatnam
ANDHRA PRADESH 		 9949483823

drdadalaratnaprabha@gmail.com 
Dr Dadala Ratna Prabha   King George Hospital  Department of Nephrology Room No 01 First Floor Andhra Medical College, Maharanipeta- 530002
Visakhapatnam
ANDHRA PRADESH 		 9949483823

ratnaprabhadadala@gmail.com 
Dr Soma Ananth   Kurnool Medical College, Government General Hospital  Department of Nephrology, Room No 1 Ground Floor, Super Specialty Block Budhawra Peta- 518002
Kurnool
ANDHRA PRADESH 		 9490884928

somaananth470@gmail.com 
Dr Santosh Kumar Maurya  Motilal Nehru Medical College  Department of Nephrology, room 112 Ground Floor, George Town Civil Line Prayagraj 211002
Allahabad
UTTAR PRADESH 		 7668182411

drsantoshnephromln@gmail.com 
Dr Pinaki Mukhopadhyay  NRS Medical College and Hospital  Department of Adult Nephrology, Room No 205 4th Floor, 138 AJC Bose Road Rajabazar Sealdah Kolkata 700014
Kolkata
WEST BENGAL 		 9231978078

drpinaki71@yahoo.com 
Dr Smita Divyaveer   PGIMER   Department of Nephrology, Ground Floor, Block C Nehru Hospital Building Sector 12
Chandigarh
CHANDIGARH 		 722756735

divyaveer.ss@gmail.com 
DrPawan Wakhare  Saikrupa Hospital  Department of Nephrology OPD No 1 Second Floor Renuka Corner Tapkir Chowk Thergaon 411033
Pune
MAHARASHTRA 		 7719016069

drpavanwakhare.research@gmail.com 
Dr Apurva Parekh  Sangini Hospital   Department of Nephrology, 1st and 7th Floor Santorini Square B/H Abhishree Complex. Starbazar Near Jodhpur Cross Road Satellite 380015
Ahmadabad
GUJARAT 		 7926465040

Drapurvaparekh333@gmail.com 
Dr Hemant Chaugule   SevenHills Healthcare Pvt Ltd   Department of Nephrology, Marol Maroshi Road, Andheri East 400059
Mumbai
MAHARASHTRA 		 9867782405

hcnephro@gmail.com 
Dr Jayesh Prabhakar Waghulde   Signus Hospital  Department of Nephrology, Room No 04 Fifth Floor, Atlanta Shoppers, Pathardi Phata Nashik 422010
Nashik
MAHARASHTRA 		 9922251176

Jayeshpwaghulde@gmail.com 
Dr Karan Kumar Saraf  SMC Heart Institute and IVF Research Centre  Department of Nephrology, Room No 08 Ground Floor Infront of BSNL Office Vidhan Sabha Road Khamardih 492007
Raipur
CHHATTISGARH 		 9644822552

Karan23387@gmail.com 
Dr Sanjeev Sharma  SMS Medical college and Attached Hospital  Department of Nephrology, JLN Marg Jaipur 302004 India
Jaipur
RAJASTHAN 		 9413337029

drsanjeevsharma@gmail.com 
Dr Amit Bhangale  Vighnaharta Multi Specialty Hospital  Department of Nephrology, Room No 05, Second Floor Pachora Central Mall, Near APMC Pachora Dist. 424201
Jalgaon
MAHARASHTRA 		 7722008658

dramitbhangale90@gmail.com 
Dr S Venkata Krishna Reddy  Vijaya Super Speciality Hospital  Department of Urology, Room No 07 Ground Floor 16-II 41 A, Raghava Cine Complex Road Pogathota 524001 India
Nellore
ANDHRA PRADESH 		 9849048222

svkkrishnareddy.vijaya@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Atmaram Child Care and Critical Care  Approved 
ETHICS COMMITTEE GSVM MEDICAL COLLEGE  Approved 
Ethics Committee S.M.S. Medical College and Attached Hospitals  Approved 
Ethics Committee S.M.S. Medical College and Attached Hospitals  Approved 
Ethics Committee Vighnaharta Multispeciality Hospital  Approved 
Ethics Committee, N.R.S. Medical College  Approved 
IEC King George Hospital  Approved 
Institutional Ethics Committee Govt. Medical College Govt.General Hospita  Approved 
Institutional Ethics Committee Govt. Medical College Govt.General Hospital   Approved 
Institutional Ethics Committee King George Hospital  Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE Kurnool Medical College/Government General Hospital   Approved 
Institutional Ethics Committee Post Graduate Institute of Medical Education and Research  Approved 
Institutional Ethics Committee, MLN Medical College Motilal Nehru Medical College  Approved 
KEM Hospital Research Centre Ethics Committee  Approved 
Medical Ethics Committee Sevenhills Sevenhills Healthcare Pvt Ltd  Approved 
PCRI Ethics Committee  Approved 
Saikrupa Hospital Institutional Ethics Committee  Approved 
Sangini Hospital Ethics Committee  Approved 
Signus Hospital Ethics Committee  Approved 
VIJAYA ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dapagliflozin 10mg Tablets and Telmisartan 80mg tablets  One tablet each of Dapagliflozin 10 mg tablet and Telmisartan 80mg tablet daily for 180 days.  
Intervention  Fixed-Dose Combination of Dapagliflozin 10 mg and Telmisartan 80mg tablets and Placebo Tablets  One tablet each of FDC of Dapagliflozin 10 mg and Telmisartan 80mg tablets and Placebo tablets daily for 180 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Willing to give consent to participate
2. Female or male aged 18-65 (both inclusive) years at the time of consent.
3. Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative urine pregnancy test.
4. UACR more than 200 and less than 5000 mg/g at visit 1.
5. eGFR greater than 25 and less than 75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1.
6. Stable, and patient with maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated.

 
 
ExclusionCriteria 
Details  1. Polycystic kidney disease, lupus nephritis or ANCA associated vasculitis.
2. Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
3. History of organ transplantation.
4. Type 1 diabetes mellitus (T1D).
5. New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment.
6. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
7. Coronary revascularization (percutaneous coronary intervention PCI or coronary artery bypass grafting CABG) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization.
8. Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigators clinical judgement.
9. Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma).
10. Hepatic impairment (aspartate transaminase AST or alanine transaminase ALT more than 3x the upper limit of normal ULN, or total bilirubin more than 2x ULN at time of enrolment).
11. Known blood-borne diseases.
12. Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast feeding.
13. Participation in another clinical study with an IP during the last month prior to enrolment.
14. Inability of the patient, in the opinion of the investigator, to understand and or comply with IP, procedures and or followup OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in UACR   Day 180 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in UACR   Baseline at Day 45, 90 and 135 
Proportion of patients demonstrating occurrence of two consecutives central laboratory values showing more than 30% decline in eGFR  Baseline, Day 90 and 180 
Proportion of patients demonstrating occurrence of two consecutives central laboratory values showing more than 40% decline in eGFR  Baseline, Day 90 and 180 
Proportion of patients demonstrating occurrence of two consecutives central laboratory values showing more than 50% decline in eGFR   Baseline, Day 90 and 180 
Proportion of patients with reduction of the incidence of patients reaching CKD 4   Day 90 and 180 
Proportion of patients with doubling of serum creatinine (compared to the most recent central laboratory measurement)   Day 45, 90 and 135 
Changes in HbA1c  Baseline, Day 90 and 180 
Change in systolic BP from   Baseline, Day 45, 90, 135 and 180 
Change from baseline in the overall summary score of the KDQOL-36   Baseline, Day 45, 90, 135 and 180 
Proportion of patients with either of Renal death, CV death or Hospitalization for heart failure   Day 180 
All-cause mortality   Day 180 
 
Target Sample Size   Total Sample Size="196"
Sample Size from India="196" 
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)   10/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

CKD is an important contributor to illness and is associated with a diminished quality of life and a reduced life expectancy. Despite the widespread availability of simple laboratory tests to identify patients with impaired kidney function, fewer clinical trials have been conducted for kidney diseases than for other common medical conditions.2 Until recently, the only classes of medication that have been shown to slow a decline in kidney function were angiotensin-converting–enzyme (ACE) inhibitors and angiotensin-receptor blockers (ARBs); however, most of the evidence was generated in patients with type 2 diabetes.

Dapagliflozin and Telmisartan not only reduces blood sugar levels and hypertension respectively but also helps in reducing the symptoms of chronic kidney disease. Dapagliflozin shows natriuretic effects and telmisartan together with causing vasodilation have anti-proteinuric effect. USFDA and global regulatory agencies have approved Dapagliflizin 10mg for the treatment of Chronic Kidney Disease. ARB’s are first line recommendation for management of CKD related changed in microalbuminuria and eGFR over long-term alongwith other recommended pharmoctherapy drugs including SGLT2. The FSC of Dapagliflozin 10mg + Telmisartan 80mg will help to reduce the pil burden of CKD patients and improve dose adherence and patient compliance to study medication by reducing the number of tablets required daily. 

The proposed study aims to evaluate the efficacy, safety and tolerability of fixed dose combination of Dapagliflozin and Telmisartan in chronic kidney disease in Indian patients.

 
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