Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: FDC of Dapagliflozin 10 mg + Eplerenone 25 mg Tablets & Placebo Tablets: Patients will be advised to take one tablet of test product and one tablet of placebo once a day orally, swallow
Sponsors
Exemed Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in urine albumin-to-creatinine ratio (UACR) of at least 20% from baseline to end of the study visit.Timepoint: 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
| Measure | Time frame |
|---|---|
| Mean change in systolic blood pressure from baseline to end of the study visit.Timepoint: 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.Timepoint: 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.Timepoint: 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.Timepoint: Throughout the study;Changes in clinical laboratory parameters from baseline to end of the study visit.Timepoint: Visit 1 - Screening or Baseline visit (Day -7) and Visit 7 - End of the study visit / Day 120 3.;Mean change in estimated glomerular filtration rate (eGFR) from baseline to end of the study visit.Timepoint: 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.Timepoint: 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 - Follo | — |
Countries
India
Contacts
Public ContactMr Mihir Upadhyay
Clinwave Research Pvt. Ltd.
Outcome results
None listed