Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan

Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan on Proteinuria in Diabetic Nephropathy Patients

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 Overview

• Status: Not yet recruiting
• Conditions: Proteinuria
• Intervention / Treatment: Drug: Losartan; Drug: Losartan + Hydrochlorothiazide

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Wasim Zahid; Phone Number: 03336361025; Email: drwasimzahid@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Bahawalpur, Punjab, Pakistan, 06318
      • Medical department, Bahawal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Losartan group; Patients will receive Losartan (LS) 50 mg per day.	Drug: Losartan; Patients will receives Losartan (LS) 50 mg per day.
Experimental: Losartan + Hydrochlorothiazide; Patients will be given losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of proteinuria	Efficacy will be labeled yes if reduction of proteinuria/albuminuria from the value before commencing treatment will be observed.	4 months

Collaborators and Investigators

• Sponsor: RESnTEC, Institute of Research

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Proteinuria; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: LosartanBVH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared with other researchers on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No