Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies

NCT05402397 | Completed Phase 4

• 1 other identifier: HGNPE 7122
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uric Acid Nephropathy

Outcome Measures

Primary Outcomes (1)

• Serum uric acid levels after losartan treatment

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

  30 days

Secondary Outcomes (1)

• Urinary uric acid levels after losartan treatment

  30 days

Study Arms (2)

Enalapril

ACTIVE COMPARATOR

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.

Drug: Losartan Potassium

Losartan

EXPERIMENTAL

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.

Drug: Losartan Potassium

Interventions

Losartan Potassium DRUG

Patients will receive losartan potassium for 30 days.

Enalapril; Losartan

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General de Niños Pedro de Elizalde: lead

Study Sites (1)

HGNPE

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

Location

Related Publications (9)

• 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.

  PMID: 32872730 BACKGROUND

• 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.

  PMID: 18335252 BACKGROUND

• 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.

  PMID: 29931555 BACKGROUND

• 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.

  PMID: 31390929 BACKGROUND

• 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.

  PMID: 33881639 BACKGROUND

• 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.

  PMID: 18670416 BACKGROUND

• 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.

  PMID: 31192008 BACKGROUND

• 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.

  PMID: 16281062 BACKGROUND

• 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.

  PMID: 11593107 BACKGROUND

MeSH Terms

Interventions

Losartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Alejandro Balestracci, MD, Ph. D.

  Hospital General de Niños Pedro de Elizalde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Nephrology Unit Hospital General de Niños Pedro de Elizalde

Model Details: Patients already treated with enalapril will be randomized to receive losartan 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 starts (enalapril or losartan, whichever was not received initially).

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 2, 2022
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: During the next 5 years after article publication.
• Access Criteria: Qualified external researchers

Locations

AR (1)