| CTRI Number |
CTRI/2025/08/092820 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Empagliflozin in Chronic Kidney Disease |
|
Scientific Title of Study
|
Effect Of Empagliflozin In Chronic Kidney Disease Patients: An Observational Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Narendra T S |
| Designation |
Post graduate, Pharmacology |
| Affiliation |
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9986833817 |
| Fax |
|
| Email |
narendra83ts@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarala N |
| Designation |
Professor and Head |
| Affiliation |
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Professor and Head, Department of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9845750165 |
| Fax |
|
| Email |
sarala241068@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarala N |
| Designation |
Professor and Head |
| Affiliation |
Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Professor and Head, Department of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar
Kolar
KARNATAKA
563101
India |
| Phone |
9845750165 |
| Fax |
|
| Email |
sarala241068@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India. Pin Code-563101 |
|
|
Primary Sponsor
|
| Name |
Narendra T S |
| Address |
Postgraduate, Department of Pharmacology, Sri Devaraj Urs Medical College, Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India. Pin Code-563101 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Narendra T S |
R L Jalappa Hospital and Research Center, Sri Devaraj Urs Medical College |
Department of Medicine Ground floor, OPD, Room number 11, Department of Nephrology, Ground floor OPD, Room number 1
Kolar
KARNATAKA |
9986833817
narendra83ts@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, Sri Devaraj Urs Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Assess the Effect of Empagliflozin on eGFR, Blood Urea, Serum Creatinine and UACR in Chronic Kidney Disease Patients
To assess adverse effects of Empagliflozin using Naranjo scale and WHO Causality assessment scale |
Blood urea, Serum creatinine, eGFR, uACR at 0(baseline), week 12 and week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |