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NCT Number: NCT06491940

Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan

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.

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Key information

Conditions

Proteinuria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical department, Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 06318, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Losartan

Drug

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

Losartan + Hydrochlorothiazide

Drug

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Wasim Zahid

CONTACT

[email protected]

03336361025

Sponsors and collaborators

Lead sponsor

RESnTEC, Institute of Research

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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