Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Tablet dapagliflozin: Tb dapagliflozin
Dose - 10mg
Frequency - once daily
For duration of 6 months to 1 year
in patients of non-diabetic CKD
Control Intervention1: Tablet Dapagliflozi
Sponsors
Pt B D Sharma PGIMS Rohtak Haryana India
Eligibility
Inclusion criteria
Inclusion criteria: All who are above the age of 18 years and less than 65 years of age at the time of consent. • eGFR =30 and =90 mL/min/1.73m2 (CKD-EPI Formula) at visit 1 or if there is evidence of increased albuminuria 3 months or more before visit 1 and UACR =200 and =5000 mg/g at visit 1.
Exclusion criteria
Exclusion criteria: Age less than 18years or more than 65years • Pregnancy • Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis • Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment • History of organ transplantation • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor • Type 1 diabetes mellitus • New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment • Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12weeks prior to enrolment • Any malignancy • Chronic Urinary Tract Infection.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To evaluate its effect on various renal and cardiovascular parameters in patients of CKD • Percentage change from baseline in 24hr proteinuria • Changes in eGFR • Need for Renal replacement therapy • Number of Hospitalisation MortalityTimepoint: At 15 days ,1 month , 3months and 6 months | — |
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Dapagliflozin on slowing disease progression and preventing complication in patients of CKD.Timepoint: At baseline , then at 4weeks, then at 13 weeks, then at 26 weeks | — |
Countries
India
Contacts
Public ContactAviral Dua
Pt B D Sharma PGIMS, Rohtak, Haryana
Outcome results
None listed