Adding a New Sugar-Lowering Tablet to the Usual Kidney-Protective Medicine to Slow Kidney Damage in Adults from Tribal Areas of Gujarat

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. - N/A

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092448

Enrollment

130

Registered

2025-08-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)

Interventions

Intervention1: 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 Control Intervention1: RAA

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
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 reductionTimepoint: 1 year	—

Secondary

Measure	Time frame
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 admissionsTimepoint: 1 year	—

Countries

India

Contacts

Public ContactDr Suraj Tripathi

Zydus Medical College and Hospital

surajpharmacol@gmail.com9926396896

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026