Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies (NCT05402397) | Clinical Trial Compass
CompletedPhase 4
Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies
Argentina40 participantsStarted 2022-07-01
Plain-language summary
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.
Who can participate
Age range
3 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum uric acid levels after losartan treatment
Timeframe: 30 days
Trial details
NCT IDNCT05402397
SponsorHospital General de Niños Pedro de Elizalde