Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan on Proteinuria in Diabetic Nephropathy Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- Reduction of proteinuria
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Losartan group
Patients will receive Losartan (LS) 50 mg per day.
Intervention: Losartan (Drug)
Losartan + Hydrochlorothiazide
Patients will be given losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy.
Intervention: Losartan + Hydrochlorothiazide (Drug)
Outcomes
Primary Outcomes
Reduction of proteinuria
Time Frame: 4 months
Efficacy will be labeled yes if reduction of proteinuria/albuminuria from the value before commencing treatment will be observed.
Secondary Outcomes
No secondary outcomes reported