Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies
NCT ID: NCT05402397
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2022-07-01
2024-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Enalapril
Children with proteinuric nephropathies will receive enalapril prior or after a losartan period, according to randomization sequence.
Enalapril will be given at a dose between 0.1 to 0.4 mg/kg/day (according to the dose that they usually receive), once a day.
Losartan Potassium
Patients will receive losartan potassium for 30 days.
Losartan
Children with proteinuric nephropathies will receive losartan prior or after a enalapril period, according to randomization sequence.
Losartan will be given at a dose 5 times the dose of enalapril that they usually receive, (with a maximum dose of 1.4 mg/kg/day), once a day.
Losartan Potassium
Patients will receive losartan potassium for 30 days.
Interventions
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Losartan Potassium
Patients will receive losartan potassium for 30 days.
Eligibility Criteria
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Inclusion Criteria
* Age between 3 and 12 years.
* Normal blood pressure.
Exclusion Criteria
* 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.
3 Years
12 Years
ALL
No
Sponsors
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Hospital General de Niños Pedro de Elizalde
OTHER
Responsible Party
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Alejandro Balestracci
Staff Nephrology Unit Hospital General de Niños Pedro de Elizalde
Principal Investigators
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Alejandro Balestracci, MD, Ph. D.
Role: PRINCIPAL_INVESTIGATOR
Hospital General de Niños Pedro de Elizalde
Locations
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HGNPE
CABA, Buenos Aires F.D., Argentina
Countries
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References
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Park JH, Jo YI, Lee JH. Renal effects of uric acid: hyperuricemia and hypouricemia. Korean J Intern Med. 2020 Nov;35(6):1291-1304. doi: 10.3904/kjim.2020.410. Epub 2020 Sep 9.
Wuhl E, Schaefer F. Therapeutic strategies to slow chronic kidney disease progression. Pediatr Nephrol. 2008 May;23(5):705-16. doi: 10.1007/s00467-008-0789-y. Epub 2008 Mar 12.
Weaver DJ Jr. Uric acid and progression of chronic kidney disease. Pediatr Nephrol. 2019 May;34(5):801-809. doi: 10.1007/s00467-018-3979-2. Epub 2018 Jun 21.
Sutton Burke EM, Kelly TC, Shoales LA, Nagel AK. Angiotensin Receptor Blockers Effect on Serum Uric Acid-A Class Effect? J Pharm Pract. 2020 Dec;33(6):874-881. doi: 10.1177/0897190019866315. Epub 2019 Aug 7.
Bryant CE, Rajai A, Webb NJA, Hogg RJ. Effects of losartan and enalapril on serum uric acid and GFR in children with proteinuria. Pediatr Nephrol. 2021 Oct;36(10):3211-3219. doi: 10.1007/s00467-021-05045-4. Epub 2021 Apr 21.
Hamada T, Ichida K, Hosoyamada M, Mizuta E, Yanagihara K, Sonoyama K, Sugihara S, Igawa O, Hosoya T, Ohtahara A, Shigamasa C, Yamamoto Y, Ninomiya H, Hisatome I. Uricosuric action of losartan via the inhibition of urate transporter 1 (URAT 1) in hypertensive patients. Am J Hypertens. 2008 Oct;21(10):1157-62. doi: 10.1038/ajh.2008.245. Epub 2008 Jul 31.
Kubota M. Hyperuricemia in Children and Adolescents: Present Knowledge and Future Directions. J Nutr Metab. 2019 May 2;2019:3480718. doi: 10.1155/2019/3480718. eCollection 2019.
Dang A, Zhang Y, Liu G, Chen G, Song W, Wang B. Effects of losartan and irbesartan on serum uric acid in hypertensive patients with hyperuricaemia in Chinese population. J Hum Hypertens. 2006 Jan;20(1):45-50. doi: 10.1038/sj.jhh.1001941.
Wurzner G, Gerster JC, Chiolero A, Maillard M, Fallab-Stubi CL, Brunner HR, Burnier M. Comparative effects of losartan and irbesartan on serum uric acid in hypertensive patients with hyperuricaemia and gout. J Hypertens. 2001 Oct;19(10):1855-60. doi: 10.1097/00004872-200110000-00021.
Other Identifiers
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HGNPE 7122
Identifier Type: -
Identifier Source: org_study_id
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