Allopurinol Effect on MDA,NO,KIM-1 Urine Levels, RI and Renal Elastography in Kidney Stone Patients Post ESWL

NCT05414669 | Completed Phase 4 DMC

• 1 other identifier: 2020.03.1.0645
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Calculi

Outcome Measures

Primary Outcomes (4)

• Oxidative Stress

  Level of Malondialdehyde (MDA), Nitric Oxide (NO), and Kidney Injury molecule-1 (KIM-1) in urine were determined by quantitative double antibody sandwich direct ELISA

  Two hours post-ESWL

• Oxidative Stress

  Level of Malondialdehyde (MDA), Nitric Oxide (NO), and Kidney Injury molecule-1 (KIM-1) in urine were determined by quantitative double antibody sandwich direct ELISA

  24 hours post ESWL

• Renal vascular and biophysical damage

  Resistive Index (RI) change of the interlobar artery and elastography of the ipsilateral renal focal zone at ESWL

  Two weeks after ESWL

• Renal vascular and biophysical damage

  Resistive Index (RI) change of the interlobar artery and elastography of the ipsilateral renal focal zone at ESWL

  One month after ESWL

Study Arms (2)

Interventional group

EXPERIMENTAL

Allopurinol 300 mg was administered orally for a total of 3 days, starting from the day before ESWL

Drug: Allopurinol Tablet 300 mg

Control Group

PLACEBO COMPARATOR

Placebo was administered orally for a total of 3 days, starting from the day before ESWL

Drug: Control Group

Interventions

Allopurinol Tablet 300 mg DRUG

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

Also known as: Allopurinol

Interventional group

Control Group DRUG

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

Also known as: Placebo

Control Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with renal stone who meet ESWL criteria
• Age 18 to 59 years old
• Consent to join this study

You may not qualify if:

• Patient with Diabetes Melitus
• Patient with hypertension
• Patient with Chronic Kidney Disease stage IV and stage V
• Patient with urinary tract infection
• Patient with obesity
• Patient with uric acid more than 9mg/dL

Sponsors & Collaborators

• Sanglah General Hospital: lead

Study Sites (1)

Sanglah General Hospital

Denpasar, Bali, 80114, Indonesia

Location

Related Publications (76)

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MeSH Terms

Conditions

Kidney Calculi

Interventions

Allopurinol; Control Groups

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Kadek B Santosa, Urologist

  Sanglah General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Key envelope was kept by third party and will be opened once the data analysis is done.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: June 10, 2022
• Study Start: August 6, 2020
• Primary Completion: March 1, 2021
• Study Completion: April 20, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)