Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan

RESnTEC, Institute of Research

Status: Not yet enrolling

Conditions: Proteinuria

Treatments: Drug: Losartan; Drug: Losartan + Hydrochlorothiazide

Study type: Interventional

Funder types: Other

Identifiers

NCT06491940

LosartanBVH

Details and patient eligibility

About

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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

Losartan group

Experimental group

Description:

Patients will receive Losartan (LS) 50 mg per day.

Treatment:

Drug: Losartan

Losartan + Hydrochlorothiazide

Experimental group

Description:

Patients will be given losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy.

Treatment:

Drug: Losartan + Hydrochlorothiazide