Effect Of Empagliflozin In Chronic Kidney Disease Patients: An Observational Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Narendra T S
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- To Assess the Effect of Empagliflozin on eGFR, Blood Urea, Serum Creatinine and UACR in Chronic Kidney Disease Patients
Overview
Brief Summary
Chronic kidney disease (CKD) is often progressive, with decreased glomerular filtration rate (GFR) and presence of albuminuria. These are the key risk factors for further deterioration of kidney functions resulting in kidney failure. Slowing CKD progression and prolonging the need for dialysis or a kidney transplant will help in improving the quality of life, decrease the cardiovascular morbidity and mortality, and also cost of kidney replacement therapy. This study aims to evaluate the effect of Empagliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, on patients with chronic kidney disease (CKD). The primary objectives are to assess changes in eGFR, Blood Urea, Serum Creatinine, and urine albumin-creatinine ratio, as well as to monitor adverse effects using the WHO causality assessment scale. This study is a prospective observational study conducted at the Medicine and Nephrology Department of R.L. Jalappa Hospital, Kolar, over a period of one and a half years. The study will include 65 CKD patients receiving Empagliflozin, with assessments at baseline, three months, and six months. Various randomized controlled trials (RCTs) have shown favorable outcomes with Empagliflozin in reducing the risk of kidney disease progression and cardiovascular death. This study aims to fill the gap in real-world clinical practice data and provide insights into the efficacy, safety, and tolerability of Empagliflozin among CKD patients.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged more than or equal to 18 years diagnosed with CKD receiving Empagliflozin.
- •Adults with an eGFR of greater than or equal to 20 and less than 45 mL/min/1.73m2 (irrespective of level of albuminuria) or an eGFR of greater than or equal to 45 and less than 90 mL/min/1.73m2 with a urinary albumin-to-creatinine ratio (uACR) greater than or equal to 200 mg/g.
Exclusion Criteria
- •CKD patients on Dialysis.
- •Type 1 diabetes mellitus.
- •History of recurrent genitourinary infections.
- •Symptomatic hypotension.
- •Hypersensitivity to empagliflozin or other SGLT-2 inhibitor.
- •Kidney transplant.
- •Pregnancy or breastfeeding.
Outcomes
Primary Outcomes
To Assess the Effect of Empagliflozin on eGFR, Blood Urea, Serum Creatinine and UACR in Chronic Kidney Disease Patients
Time Frame: Blood urea, Serum creatinine, eGFR, uACR at 0(baseline), week 12 and week 24
To assess adverse effects of Empagliflozin using Naranjo scale and WHO Causality assessment scale
Time Frame: Blood urea, Serum creatinine, eGFR, uACR at 0(baseline), week 12 and week 24
Secondary Outcomes
No secondary outcomes reported
Investigators
Narendra T S
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research