NCT03865407

Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease

Terminated Phase 2 Results posted Last updated 27 May 2021

What this trial tests

Phase 2 trial testing Allopurinol in Hyperuricemia in 17 participants. Terminated before completion.

Timeline

10 March 2019

Primary endpoint
7 October 2020

7 October 2020

Quick facts

Lead sponsor	Virginia Commonwealth University
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	10 March 2019
Primary completion	7 October 2020
Estimated completion	7 October 2020
Sites	1 location across United States

Drugs / interventions tested

• Allopurinol (ALLOPURINOL) — full drug profile →

Conditions studied

• Hyperuricemia — all drugs for Hyperuricemia →
• Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →

Sponsor

Virginia Commonwealth University

Who can join

Adults 2 to 20, any sex, with Hyperuricemia or Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

eGFR Change Primary · The difference in Cystatin C eGFR between baseline and 6 months will be measured

Change in Cys-C eGFR over time

Group	Value	95% CI
Allopurinol	3.14	± 3.716
Standard of Care Control	-0.29	± 5.251

eGFR Change Primary · The difference in Creatinine eGFR between baseline and 6 months will be measured

Change in Creatinine eGFR over time

Group	Value	95% CI
Allopurinol	3.86	± 7.798
Standard of Care Control	0	± 3.857

Serum Uric Acid Change Secondary · The difference in Serum Uric Acid between baseline and 6 months will be measured

Change in Serum Uric Acid

Group	Value	95% CI
Allopurinol	-3.33	± 0.996
Standard of Care Control	-0.46	± 0.964

Systolic Blood Pressure Secondary · The difference in clinic systolic blood pressure between baseline and 6 months will be measured

Change in systolic blood pressure

Group	Value	95% CI
Allopurinol	-6.5	± 13.126
Standard of Care Control	2.29	± 6.264

Diastolic Blood Pressure Secondary · The difference in clinic diastolic blood pressure between baseline and 6 months will be measured

Change in diastolic blood pressure

Group	Value	95% CI
Allopurinol	-7.33	± 6.29
Standard of Care Control	3.983	± 7.543

Serum High Sensitivity C-reactive Protein (Hs-CRP) Secondary · Serum hs-CRP will be measured at baseline and 6 months

Compare the mean difference of serum hs-CRP from baseline to 6 months between groups

Group	Value	95% CI
Allopurinol	1.66	± 3.724
Standard of Care Control	-7.64	± 18.639

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Allopurinol

Serious: 1/7 (14%)

Deaths: 0/7

Standard of Care Control

Serious: 0/7 (0%)

Deaths: 0/7

Serious adverse events (1 terms)

Reaction	System	Allopurinol	Standard of Care Control
Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome	Immune system disorders	—	—

Most-reported serious reactions: Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome.

Data from ClinicalTrials.gov NCT03865407 adverse events section.

Sponsor's own description

Aim 1. To determine the effect of Allopurinol treatment on renal function (glomerular filtration rate, GFR) in pediatric chronic kidney disease (CKD) patients with high uric acid levels (hyperuricemia).

Aim 2. Establish whether Allopurinol treatment reduces Nlrp3 inflammasome and renal injury biomarkers.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic Strategies for the Treatment of Chronic Hyperuricemia: An Evidence-Based Update.
   Cicero AFG, Fogacci F, Kuwabara M, Borghi C. · · 2021 · cited 50× · PMID 33435164 · DOI 10.3390/medicina57010058
2. The dirty little secret of urate-lowering therapy: useless to stop chronic kidney disease progression and may increase mortality.
   Gonzalez-Martin G, Cano J, Carriazo S, Kanbay M, et al · · 2020 · cited 17× · PMID 33391737 · DOI 10.1093/ckj/sfaa236
3. Repurposing mitochondria-targeted therapeutics for kidney diseases.
   Thompson AD, Victor Santiago Raj P, Scholpa NE, Schnellmann RG. · · 2025 · cited 8× · PMID 39855593 · DOI 10.1016/j.kint.2024.12.020