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临床试验/CTRI/2025/08/092820
CTRI/2025/08/092820尚未招募不适用

Effect Of Empagliflozin In Chronic Kidney Disease Patients: An Observational Study

Narendra T S1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2025年8月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
65
试验地点
1
主要终点
To Assess the Effect of Empagliflozin on eGFR, Blood Urea, Serum Creatinine and UACR in Chronic Kidney Disease Patients

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

To Assess the Effect of Empagliflozin on eGFR, Blood Urea, Serum Creatinine and UACR in Chronic Kidney Disease Patients

时间窗: 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

时间窗: Blood urea, Serum creatinine, eGFR, uACR at 0(baseline), week 12 and week 24

次要结局

未报告次要终点

研究者

发起方
Narendra T S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Narendra T S

Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research

研究点 (1)

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Effect of Empagliflozin in Chronic Kidney Disease | 临床试验