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A study to compare combination therapy of diabetic and anti hypertensive drugs with only anti hypertensive drug in patients with Chronic kidney disease

A randomized controlled trial to compare the efficacy of combination therapy of SGLT2 inhibitor and ARB to ARB monotherapy on clinical outcomes in patients with CKD - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/060195
Enrollment
78
Registered
2023-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Dapagliflozin and Telmisartan: Dapagliflozin 10 mg OD, po for 3 months Telmisartan 40 mg OD, po for 3 months Control Intervention1: Telmisartan: 40 mg OD, po for 3 months

Sponsors

Dr Nithesh Babu R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gfr greater than 25 ml/min/m2 2. Urine albumin creatinine ratio greater than 30 mg/g with or without hypertension 3. Type 2 Diabetes mellitus 4. Hypertension

Exclusion criteria

Exclusion criteria: 1. Patients not willing to give informed consent 2. Patients with end stage renal disease 3. Patients with acute renal failure 4. Patients with albumin creatinine ratio less than 30 mg/g 5. Pregnant and lactating mothers

Design outcomes

Primary

MeasureTime frame
Estimation of EGFR and Urine albumin creatinine ratioTimepoint: Every month for 3 months

Secondary

MeasureTime frame
Blood pressure, lipid profile, serum creatinine, HbA1c, fasting glucose and rates of clinical adverse events such as myocardial infarction, stroke or end-stage renal diseaseTimepoint: 3 MONTHS

Countries

India

Contacts

Public ContactMahendra Kumar K

Saveetha Medical College Hospital

mahindran1985@gmail.com9445645171

Outcome results

None listed

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