Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: 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 ta
Sponsors
ERIS LIFESCIENCES LIMITED
ERIS LIFESCIENCES LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in UACRTimepoint: Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in UACRTimepoint: Baseline at Day 45, 90 and 135;Proportion of patients demonstrating occurrence of two consecutives central laboratory values showing more than 30% decline in eGFRTimepoint: Baseline, Day 90 and 180;Proportion of patients demonstrating occurrence of two consecutives central laboratory values showing more than 40% decline in eGFRTimepoint: Baseline, Day 90 and 180;Proportion of patients demonstrating occurrence of two consecutives central laboratory values showing more than 50% decline in eGFRTimepoint: Baseline, Day 90 and 180;Proportion of patients with reduction of the incidence of patients reaching CKD 4Timepoint: Day 90 and 180;Proportion of patients with doubling of serum creatinine (compared to the most recent central laboratory measurement)Timepoint: Day 45, 90 and 135;Changes in HbA1cTimepoint: Baseline, Day 90 and 180;Change in systolic BP fromTimepoint: Baseline, Day 45, 90, 135 and 180;Change from baseline in the overall summary score of the KDQOL-36Timepoint: Baseline, Day 45, 90, 135 and 180;Proportion of patients with either of Renal death, CV death or Hospitalization for heart failureTimepoint: Day 180;All-cause mortalityTimepoint: Day 180 | — |
Countries
India
Contacts
Public ContactMr Ganesh Boddu
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed