| CTRI Number |
CTRI/2025/08/092448 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Adding a New Sugar-Lowering Tablet to the Usual Kidney-Protective Medicine to Slow Kidney Damage in Adults from Tribal Areas of Gujarat” |
|
Scientific Title of Study
|
Comparison of the renoprotective effect of SGLT-2 inhibitor with RAAS inhibitor versus RAAS inhibitor alone in Chronic Kidney Disease”: A Randomized Controlled Trial in the Tribal Population of Gujarat. |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Bhupatbhai Bhalala |
| Designation |
Post Graduate Resident |
| Affiliation |
Zydus Medical College and Hospital |
| Address |
Department of Pharmacology,
Zydus Medical College and Hospital,Nimnaliya-Muvaliya, Dahod.
Dohad
GUJARAT
389151
India |
| Phone |
9978244738 |
| Fax |
|
| Email |
abhibhalala007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suraj Tripathi |
| Designation |
Professor and Head of Department |
| Affiliation |
Zydus Medical College and Hospital |
| Address |
Department of Pharmacology,
Zydus Medical College and Hospital, Nimnaliya-Muvaliya, Dahod.
Dohad
GUJARAT
389151
India |
| Phone |
9926396896 |
| Fax |
|
| Email |
surajpharmacol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suraj Tripathi |
| Designation |
Professor and Head of Department |
| Affiliation |
Zydus Medical College and Hospital |
| Address |
Department of Pharmacology,
Zydus Medical College and Hospital, Nimnaliya-Muvaliya, Dahod.
Dohad
GUJARAT
389151
India |
| Phone |
9926396896 |
| Fax |
|
| Email |
surajpharmacol@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zydus Medical College and Hospital, Dahod-389151, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Dr Abhishek Bhalala |
| Address |
Department of Pharmacology, Zydus Medical College and Hospital, Dahod-389151, Gujarat. |
| 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 Abhishek Bhalala |
Zydus Medical College and Hospital |
Ground Floor, Deaprtment of Medicine/ Department of Nephrology OPD, NCD Clinic, Zydus Medical College and Hospital, Dahod-389151, Gujarat.
Dohad
GUJARAT |
9978244738
abhibhalala007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ZMCH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
RAAS inhibitor alone, |
The comparator agent will be any RAAS inhibitor ( ACE/ARB ), with the dose and frequency determined according to established guidelines and standard protocolsfor duration of 1 year |
| Intervention |
SGLT-2 inhibitor + RAAS inhibitor |
Dapagliflozin 10mg OD + ACE/ARB specific drug dose, frequncy will be based on particular drug and duration will be of 1year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Signed informed consent form prior to any study specific procedures
2) Female or male aged more than and equal to 18 years at the time of enrollment
3) CKD Stage 3a/b based on eGFR more than and equal to 30 and less than and equal to 60 mL/min/1.73m2 (CKD-EPI formula) or Proteinuria more than and equal to 1+ on standard urine dipstick correspond to UPCR more than 30 mg/g |
|
| ExclusionCriteria |
| Details |
1. Hypersensitivity (Known allergy) to SGLT2 inhibitor or RAAS Blocker.
2. Genitourinary infection (if not treated successfully).
3. CKD stage 4 or ESRD based on S.Cr measured eGFR ( CKD EPI ).
4. Kidney transplant patient.
5. Pregnant and lactating women.
6. Participation in another interventional clinical trial within 4 weeks prior
to baseline and during the current trial.
7. New York Heart Association (NYHA) class IV Congestive Heart Failure
at the time of enrolment.
8. Type 1 diabetes mellitus (T1D) |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The research hypothesizes that combined SGLT-2 inhibitor and RAAS inhibitor therapy may outperform RAAS inhibitor monotherapy in preserving kidney
function, as measured by:
1. Slower eGFR deterioration
2. More pronounced albuminuria reduction |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Superior hypertension management
2. Favourable metabolic effects
3. Furthermore, the combination may substantially reduce risks of: CKD
progression to end-stage disease, Cardiovascular complications, Heart
failure-related admissions |
1 year |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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 Yet Recruiting |
| 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
|
This randomized controlled trial aims to compare the renoprotective effects of SGLT-2 inhibitors (dapagliflozin) combined with RAAS inhibitors versus RAAS inhibitors alone in stage 3 chronic kidney disease (CKD) patients from the tribal population of Gujarat. The study will evaluate changes in eGFR, proteinuria, blood pressure, metabolic parameters, and cardiovascular outcomes over a 12-month period. With 130 participants, the trial addresses a critical gap in Indian data on combination therapy. Findings may guide CKD management strategies in underrepresented communities, offering potential improvements in disease progression, metabolic control, and overall clinical outcomes. |