Uric Acid NephropathyPhase 4NCT05402397
Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies
A Phase 4 study testing Losartan Potassium in people with Uric Acid Nephropathy, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Uric Acid Nephropathy
- What is being tested?
- Losartan Potassium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Jul 2022to 1 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with poteinuric nephropathies already treated with enalapril under our care.
- Age between 3 and 12 years.
- Normal blood pressure.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies: a Cross-over Randomized Clinical Trail
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.
Read the detailed description
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.
- Conditions
- Uric Acid Nephropathy
- Being tested
- Losartan Potassium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Losartan PotassiumDrug
Patients will receive losartan potassium for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Losartan Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum uric acid levels after losartan treatment
Patiens will receive a losartan regime after serum uric acid levels will be assessed
Measured: 30 days
Secondary outcomes (1)
Urinary uric acid levels after losartan treatment
Patiens will receive a losartan regime after urinary uric acid levels will be assessed
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Uric Acid NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Niños Pedro de Elizalde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Balestracci, Hospital General de Niños Pedro de Elizalde
- Investigators
- Alejandro Balestracci, MD, Ph. D., Principal investigator, Hospital General de Niños Pedro de Elizalde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402397
- Sponsor's protocol ID
- HGNPE 7122
- Status last verified
- Sep 2025
- First submitted
- 30 May 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The authors will share the generated data with qualified external researchers during the next 5 years after article publication. All data provided will be anonymized to respect the privacy of patients who have participated in the trail in line with applicable laws and regulations.
Publications
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.
PubMed 32872730Wuhl 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.
PubMed 18335252Weaver 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.
PubMed 29931555Sutton 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.
PubMed 31390929Bryant 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.
PubMed 33881639Hamada 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.
PubMed 18670416Kubota 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.
PubMed 31192008Dang 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.
PubMed 16281062Wurzner 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.
PubMed 11593107
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies: a Cross-over Randomized Clinical Trail
- ClinicalTrials.gov ID
- NCT05402397
- Acronym / sponsor ID
- HGNPE 7122
- Conditions
- Uric Acid Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital General de Niños Pedro de ElizaldeUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Enalapril | Active comparator | Drug: Losartan PotassiumChildren 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 | Experimental | Drug: Losartan PotassiumChildren 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with poteinuric nephropathies already treated with enalapril under our care.
- Age between 3 and 12 years.
- Normal blood pressure.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Losartan PotassiumPatients will receive losartan potassium for 30 days. | Drug | Enalapril, Losartan |
Primary outcome
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
1 secondary outcome
Urinary uric acid levels after losartan treatment
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 32872730Park 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.
- Results publication: PubMed 18335252Wuhl 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.
- Results publication: PubMed 29931555Weaver 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.
- Results publication: PubMed 31390929Sutton 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.
- Results publication: PubMed 33881639Bryant 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.
- Results publication: PubMed 18670416Hamada 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.
- Results publication: PubMed 31192008Kubota 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.
- Results publication: PubMed 16281062Dang 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.
- Results publication: PubMed 11593107Wurzner 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.
- Individual participant dataSharing planned: Yes. The authors will share the generated data with qualified external researchers during the next 5 years after article publication. All data provided will be anonymized to respect the privacy of patients who have participated in the trail in line with applicable laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Balestracci, MD, Ph. D. principal investigator
Hospital General de Niños Pedro de Elizalde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan Potassium in people with Uric Acid Nephropathy, run by Hospital General de Niños Pedro de Elizalde at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum uric acid levels after losartan treatment (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402397, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.