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How SGLT2-I and and Angiotensin receptor blockers together affect Diabetic kidney disease

The Descriptive Study on Assessment of the effects of combination of SGLT 2 Inhibitors (SGLT2-I) and Renin Angiotensin Aldosterone System (RAAS) Blockers (RAAS-I) on the renal functions of patients of diabetic kidney disease (DKD) on the population of patients from the Southern part of West Bengal (SGRAAS-DKD) - SGRAAS-DKD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/05/042657
Enrollment
600
Registered
2022-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: Not applicable: Not applicable Control Intervention1: Not applicable: Not applicable

Sponsors

Thakurpukur Medical Society
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed case of Diabetic Kidney Disease Type 2 Diabetes Mellitus with a. Urinary Spot ACR > 30 mg/g and / or b. eGFR, calculated by CKD-EPI c. Receiving RAAS-I for at least 4 weeks d. Recently initiated on SGLT2-I

Exclusion criteria

Exclusion criteria: 1. eGFR, calculated by CKD-EPI 2. Non-consenting patients 3. Doubt about the nature of kidney disease. Suspicion of nondiabetic renal disease such as renal artery stenosis, glomerular disease or other systemic disorders with renal involvement 4. Ongoing active infection, sepsis or symptomatic UTI, active malignancy 5. History of symptomatic UTI in the past 6 months

Design outcomes

Primary

MeasureTime frame
Composite of : 50% decline in eGFR from baseline OR eGFR falling below 15 ml/min/1.73m2 OR initiation of hemodialysis Timepoint: 58 weeks

Secondary

MeasureTime frame
50% reduction in albuminuria OR albuminuria decreasing from A3 to A2/A1 or A2 to A1Timepoint: 58 weeks;eGFR at the end of the study periodTimepoint: 58 weeks;Major Cardiovascular End Points: Occurrence of Myocardial infarction, stroke, hospitalisation due to heart failure or deathTimepoint: any time up to 58 weeks

Countries

India

Contacts

Public ContactDr Susovan Halder

Thakurpukur Medical Society

susovanhalder@gmail.com9831722267

Outcome results

None listed

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