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Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?

Information source: Mansoura University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Calculi

Intervention: Antioxidant group (Drug); Calcium Channel Blockers (Drug); Angiotensin receptor blocker group (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Mansoura University

Official(s) and/or principal investigator(s):
Ahmed R. EL-Nahas, MD, Principal Investigator, Affiliation: Mansoura University


This study will be conducted to evaluate the protective effects and mechanisms of antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.

Clinical Details

Official title: A Randomized Controlled Trial for Evaluating Protective Effects of Antioxidants (Selenium and Vitamins A, C and E), Calcium Channel Blocker (Verapamil) and Angiotensin Receptor Blocker (Losartan) Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Renal damage

Secondary outcome: The mechanisms of renal protection

Detailed description: The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine. The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria: 1. Well functioning kidney (serum creatinine <1. 2 mg/dl). 2. Solitary renal stone. 3. Size: 25 mm or less in the largest diameter. Exclusion Criteria: 1. Contraindications to ESWL 2. Previous surgical treatment of renal stones. 3. Congenital renal anomalies. 4. Pediatric patients (age <18 years). 5. Patients with Diabetes or hypertension

Locations and Contacts

Urology and Nephrology Center, Mansoura 35516, Egypt
Additional Information

Starting date: August 2012
Last updated: October 8, 2014

Page last updated: August 23, 2015

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