CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 35 enrolled
Drug / intervention
Allopurinol Tablet 300 mg +1 moredrug
Likely dose
Allopurinol Tablet 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05414669
NCT05414669Phase 4Completed

The Effect of Allopurinol on Malondialdehyde, Nitric Oxide, Kidney Injury Molecule-1 Urine Levels, Resistive Index and Renal Elastography in Kidney Stone Patients After Extra Corporeal Shockwave Lithotripsy

Sanglah General Hospital·interventional·Posted Jun 10, 2022·Updated Jun 10, 2022

In Brief

A Phase 4 clinical trial evaluating Allopurinol Tablet 300 mg and Control Group for Kidney Calculi. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Extracorporeal shock wave lithotripsy (ESWL) is accepted as the first treatment choice for most urinary stones. Still, it has adverse effects on the kidneys. The mechanism underlying the shock wave induced renal injury is not entirely understood, and oxidative stress has been speculated to be involved in this process. The Investigator evaluated the role of allopurinol, which works as a xanthine oxidase inhibitor and free radical scavenger in renal protection against oxidative effects of ESWL. In a randomized, double-blind placebo-controlled trial, a total of 70 patients with renal stones undergoing ESWL were randomly assigned to 2 groups. Group 1 receive allopurinol, and group 2 receive a placebo. Allopurinol 300mg was given orally for a total of 3 days, beginning a day before ESWL. The urinary excretion of malondialdehyde (MDA), nitric oxide (NO), and kidney injury molecule-1 (KIM-1) were determined by quantitative double antibody sandwich direct ELISA at baseline before ESWL then repeatedly two h, and 24 h after ESWL. The resistive index (RI) change of the interlobar artery was asses along with the measurement of the shear wave velocity (SWV) in the focal zone of the treated kidney before, two weeks, and four weeks after ESWL. Multivariate analyses were performed using repeated measure ANOVA to control covariates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Calculi
CountriesIndonesia
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJun 10, 2022
Enrollment StartAug 6, 2020
Primary CompletionMar 1, 2021
Study CompletionApr 20, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.1 years ago

Interventions

Allopurinol Tablet 300 mgdrug

Allopurinol 300mg was given orally for a total of 3 days, beginning a day before ESWL.

Control Groupdrug

Placebo was given orally for a total of 3 days, beginning a day before ESWL.