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Completed

NCT Number: NCT05402397

Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies

The aim of this study is to assess the serum uric-acid lowering effect of losartan in children with proteinuric nephropathies. Patients already treated with enalapril will be randomized to receive losartan and/or enalapril in a cross-over designed study. Those who recruit the inclusion criteria will receive enalapril and/or losartan during a one month period, followed by a 15 days of wash out (under enalapril treatment). On day 46, the second period of 30 days of treatment start (enalapril or losartan, whichever was not received initially). Before randomization, a baseline 24 hours urine and a fasting blood sample will be obtained to assess uric acid excretion and serum uric acid values along with renal function and electrolyte levels. Then, similar determinations will be performed at days 30, 46 and 76.

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

HGNPE

CABA, Buenos Aires F.D., 1417, Argentina

About this study

The working hypothesis is that the administration to losartan reduces significantly the serum uric acid levels in normotensive children with proteinuric nephropathies. The study will consist in a single center cross-over randomized, open label, clinical trial.

Inclusion criteria

will be:children with poteinuric nephropathies already treated with enalapril under our care, age between 3 and 12 years and normal blood pressure.

Subjects will be selected by simple probability sampling and after the signature of the assent/informed consent, they will be randomized (blocks of 4 patients, treatment sequence 2:2) to receive a two phases regime of drugs: 1) arm enalapril-losartan, or 2) arm losartan-enalapril. Between phases there will be a 14 days wash out period (during this time patients will continue receiving enalapril, as this drug does not have effect on uric acid metabolism). The dose of enalapril will be that they usually receive, while the dose of losartan will be 5 times the those of enalapril that they usually receive.

Visit Schedule: day 1 (randomization) and 30 for the first drug; 15 days wash out period, day 46 and 76 for the second drug. In each visit a physical examination and blood pressure monitor will be performed, along with the following laboratory parameters: urea, creatinine, electrolytes, uric acid, glycemia, triglycerides, cholesterol and lipopolysaccharides. Simultaneously, in a spot urine morning sample will be determined the levels of uric acid, creatinine, proteinuria y albuminuria.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with poteinuric nephropathies already treated with enalapril under our care.
  • Age between 3 and 12 years.
  • Normal blood pressure.

Exclusion criteria

  • Patients with high blood pressure.
  • Post menarche female patients.
  • Patients with hypouricemia (< 2 mg/dL).
  • Patients treated with diuretics.
  • Patients with absolute or relative contraindications to receive RAAS antagonists (glomerular filtration < 30 ml/min/1,73 m2, serum potassium > 5,5 mEq/L).
  • Patients with active rheumatic diseases.
  • Patients treated with dual blockade of the RAAS (enalapril +losartan).
  • Patients treated with calcineurin inhibitors.

Treatment and study plan

Losartan Potassium

Drug

Patients will receive losartan potassium for 30 days.

Primary outcomes

  1. Serum uric acid levels after losartan treatment

    Time frame: 30 days

    Patiens will receive a losartan regime after serum uric acid levels will be assessed

Secondary outcomes

  1. Urinary uric acid levels after losartan treatment

    Time frame: 30 days

    Patiens will receive a losartan regime after urinary uric acid levels will be assessed

Sponsors and collaborators

Lead sponsor

Hospital General de Niños Pedro de Elizalde

Other

Registry information

Official study title

Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies: a Cross-over Randomized Clinical Trail

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 2, 2022
Registry last updated
Sep 15, 2025

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.