CTRI/2025/03/081870 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On:
07/01/2026
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 Study to assess the Efficacy and safety of Dapagliflozin plus Eplerenone Tablets in Kidney Patients
Scientific Title of Study
A Multicentric, Prospective, Active Controlled, Parallel Group, Randomized, Double Blind, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Dapagliflozin plus Eplerenone Tablets Versus Concomitant Administration of Dapagliflozin Tablets and Eplerenone Tablets in Patients with Chronic Kidney Disease.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2023/72, Version No.:01 and Dated Nov 21, 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Medchal TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Medchal TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Mr Mihir Upadhyay
Designation
Sr. Manager - Regulatory Affairs
Affiliation
Exemed Pharmaceuticals
Address
Plot No. 133/1 and 133/2, GIDC, Selvas Road, Vapi.
Valsad GUJARAT 396195 India
Phone
7405490368
Fax
Email
mihir.upadhyay@exemedpharma.com
Source of Monetary or Material Support
Exemed Pharmaceuticals, Plot No. 133 by 1 & 133 by 2, GIDC, Selvas Road, Vapi-396195, Gujarat, India.
Primary Sponsor
Name
Exemed Pharmaceuticals
Address
Plot No. 133 by 1 & 133 by 2, GIDC, Selvas Road, Vapi-396195,
Gujarat, India.
Institutional Ethics Committee, Motilal Nehru Medical College
Approved
Prakash Medical College Institutional Ethics Committee, Prakash Institute of Medical Sciences & Research (PIMS&R)
Approved
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College Institutional Ethics Committee 2 (RCSMGMCIEC2), Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital
Approved
Supe Hospital Ethics Committee, Supe Heart Diabetes Hospital and Research Centre
Concomitant Administration of Dapagliflozin Tablets 10 mg and Eplerenone Tablets 25 mg
Patients will be advised to take one tablet of Dapagliflozin Tablets 10 mg and one tablet of Eplerenone Tablets 25 mg once a day orally, swallowed with water around same time every day for 4 months (120 days).
Patients will be advised to take one tablet of test product and one tablet of placebo once a day orally, swallowed with water around same time every day for 4 months (120 days).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female patients aged 18 to 65 years (both inclusive).
2. Patients with estimated glomerular filtration rate (eGFR) more than 30 mL per min per 1.73 m2 and less than 90 mL per min per 1.73 m2 (using the CKD-EPI formula) for more than 3 months and at screening visit.
3. Patients with evidence of increased albuminuria for 3 months or more before screening visit and urine albumin-to-creatinine ratio (UACR) more than or equal to 100 and less than equal to 3500 mg per g at screening visit
4. Patients with serum potassium levels less than or equal to 5 mmol per L at screening visit.
5. Patients who are on stable doses of ACEIs or ARBs for more than 4 weeks.
6. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception screening or baseline visit.
7. Patient with ability to understand and provide written, signed and dated informed consent form, which must have been obtained prior to screening.
8. Patients willing to comply with all the protocol requirements.
ExclusionCriteria
Details
1. Patients with a history of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus.
2. Patients with a history of metabolic acidosis or diabetic ketoacidosis.
3. Patients with autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis.
4. Patients with a history of polycystic kidney disease and/or renal artery stenosis.
5. Patients who are receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
6. Patients with a history of organ transplantation.
7. Patients who are receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor.
8. Patients with MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to screening.
9. Patients with significant cardiovascular disease such as myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) less than 6 months before screening.
10. Patients with Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to randomization or planned to undergo any of these operations after randomization.
11. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
12. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
13. Patients with type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than or equal to 8%.
14. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and/or Total bilirubin more than 2X the UNL) at screening.
15. Patients with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and/or diastolic BP greater than or equal to 100 mmHg at screening.
16. Patients with a history of autonomic dysfunction (e.g., history of fainting or clinically significant orthostatic hypotension).
17. Patients with a history of amputations.
18. Patients with eGFR change greater than 30% in the last six months before screening.
19. Patients with current therapy with renin inhibitor or MRA.
20. Patients with intolerance or contraindications to drugs inhibiting the Renin-Angiotensin-Aldosterone System (RAAS). Cyclosporine A, Tacrolimus, Trimethoprim due to increased risk of hyperkalemia in combination with Eplerenone. Ketoconazole, Itraconazole, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin and Nefazadone, Lithium, Amiodarone, Diltiazem, Verapamil due to increase in toxicity when combined with Eplerenone. Rifampicin, Carbamazepine, Phenytoin, Phenobarbital due to the risk of decreased eplerenone efficacy.
21. Patients suffering from severe urinary tract infections (e.g., urosepsis, pyelonephritis), necrotizing fasciitis of the Perineum (Fournier’s Gangrene), intravascular volume contraction and/or female genital mycotic infections prior to 6 months from screening.
22. Patients with history of inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption.
23. Patients with any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
24. Patients with a history of anaemia or haemoglobinopathy and/or haemoglobin less than 10 g/dL for men; haemoglobin less than 9 g/dL for women at screening.
25. Patients with intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication.
26. Patients with known immunocompromised status.
27. Patients with a history of any malignancy.
28. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
29. Patients with donation or transfusion of blood, plasma, or platelets within the past 3 months prior to screening.
30. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
31. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
32. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
33. Patients with suspected inability or unwillingness to comply with the study procedures.
34. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
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
Percentage change in urine albumin-to-creatinine ratio (UACR) of at least 20% from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -7),
Visit 3 - Follow up visit / Day 15±3,
Visit 4 - Follow up visit / Day 30±3,
Visit 5 - Follow up visit / Day 60±3,
Visit 6 - Follow up visit / Day 90±3 and
Visit 7 - End of the study visit / Day 120±3.
Secondary Outcome
Outcome
TimePoints
Mean change in estimated glomerular filtration rate (eGFR) from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -7),
Visit 3 - Follow up visit / Day 15±3,
Visit 4 - Follow up visit / Day 30±3,
Visit 5 - Follow up visit / Day 60±3,
Visit 6 - Follow up visit / Day 90±3 and
Visit 7 - End of the study visit / Day 120±3.
Mean change in serum potassium levels from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -7),
Visit 3 - Follow up visit / Day 15±3,
Visit 4 - Follow up visit / Day 30±3,
Visit 5 - Follow up visit / Day 60±3,
Visit 6 - Follow up visit / Day 90±3 and
Visit 7 - End of the study visit / Day 120±3.
Mean change in systolic blood pressure from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -7),
Visit 2 - Randomization visit (Day 1),
Visit 3 - Follow up visit / Day 15±3,
Visit 4 - Follow up visit / Day 30±3,
Visit 5 - Follow up visit / Day 60±3,
Visit 6 - Follow up visit / Day 90±3 and
Visit 7 - End of the study visit / Day 120±3.
Mean change in urine albumin-to-creatinine ratio (UACR) from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -7),
Visit 3 - Follow up visit / Day 15±3,
Visit 4 - Follow up visit / Day 30±3,
Visit 5 - Follow up visit / Day 60±3,
Visit 6 - Follow up visit / Day 90±3 and
Visit 7 - End of the study visit / Day 120±3.
Percentage change in estimated glomerular filtration rate (eGFR) from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -7),
Visit 3 - Follow up visit / Day 15±3,
Visit 4 - Follow up visit / Day 30±3,
Visit 5 - Follow up visit / Day 60±3,
Visit 6 - Follow up visit / Day 90±3 and
Visit 7 - End of the study visit / Day 120±3.
Adverse events or serious adverse events reported during the study.
Throughout the study
Changes in clinical laboratory parameters from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -7) and
Visit 7 - End of the study visit / Day 120±3.
Target Sample Size
Total Sample Size="220" Sample Size from India="220" Final Enrollment numbers achieved (Total)= "220" Final Enrollment numbers achieved (India)="220"
Phase of Trial
Phase 3
Date of First Enrollment (India)
24/03/2025
Date of Study Completion (India)
06/11/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
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
This trial is a multicentric, prospective, active controlled, parallel group, randomized, double blind, comparative, phase III clinical study to evaluate the efficacy, safety and tolerability of fixed dose combination of Dapagliflozin plus Eplerenone Tablets versus concomitant administration of Dapagliflozin Tablets and Eplerenone Tablets in patients with chronic kidney disease.
Patients who are willing and able to participate in the study will sign and date the Informed Consent Form on the day of screening / baseline visit (Visit 1). During this screening period, patients who are willing to give consent will be evaluated for all the eligibility criteria. Eligible patients (male or female) aged 18 to 65 years (both inclusive) who are fulfilling all the inclusion and none of the exclusion criteria will be enrolled into the study.
After confirming the inclusion/exclusion criteria the patient will be randomized and provided with study medication at randomization visit. Patients will be provided with patient diary at randomization visit, which need to be brought along with in each subsequent visit till the last visit. Follow up visits will be done on day 15(±3), day 30(±3), day 60(±3), day 90(±3) and day 120(±3) (final visit) of treatment to assess efficacy, safety and tolerability.
Patients will be assigned to either of the two arms i.e., Arm A or Arm B consisting of FDC of Dapagliflozin 10 mg + Eplerenone 25 mg Tablets & Placebo Tablets (Arm A) or Concomitant Administration of Dapagliflozin Tablets 10 mg and Eplerenone Tablets 25 mg (Arm B).