Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan

Not Applicable

Not yet recruiting

• Conditions: Proteinuria
• Interventions: Drug: Losartan; Drug: Losartan + Hydrochlorothiazide

• Registration Number: NCT06491940
• Lead Sponsor: RESnTEC, Institute of Research

Brief Summary

Losartan, an angiotensin II receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. However, the addition of a diuretic like hydrochlorothiazide may offer synergistic benefits in reducing proteinuria by addressing both the underlying renal pathology and potential volume overload in these patients. The current study aims at determining and comparing the role of losartan alone vs hydrochlorothiazide plus losartan in reducing proteinuria in diabetic nephropathy patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09
• Study Start: 2024-08-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

• Patients of both genders with ≥18 years of age.
• Presence of proteinuria/albuminuria at time of screening.
• Creatinine clearance of 30 mL/min or higher.

Exclusion Criteria

• A systolic blood pressure of 180 mm Hg or higher, a diastolic blood pressure of 110 mm Hg or higher.
• Presence of a second primary renal disease in addition to diabetic nephropathy.
• Patients with type 1 diabetes.
• A history of a cardiovascular or cerebrovascular event within 3 months before inclusion.
• Serum potassium of 6.0 mmol/L or higher.
• Transplantation or immunosuppressive treatment.
• Contraindication for the use of losartan or hydrochlorothiazide.
• Pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Losartan group	Losartan	Patients will receive Losartan (LS) 50 mg per day.
Losartan + Hydrochlorothiazide	Losartan + Hydrochlorothiazide	Patients will be given losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy.

Primary Outcome Measures

Name	Time	Method
Reduction of proteinuria	4 months	Efficacy will be labeled yes if reduction of proteinuria/albuminuria from the value before commencing treatment will be observed.

Trial Locations

Locations (1)

Medical department, Bahawal Victoria Hospital; 🇵🇰 Bahawalpur, Punjab, Pakistan