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Renal Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shock Wave Lithotripsy Induced Renal Injury (SWL)

This study is currently recruiting participants.
Verified August 2012 by Mansoura University
Sponsor:
Information provided by (Responsible Party):
Ahmed R. EL-Nahas, Mansoura University
ClinicalTrials.gov Identifier:
NCT01675362
First received: August 27, 2012
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Lithotripsy
 Drug: Antioxidant group
Drug: Calcium Channel Blockers
Drug: Angiotensin receptor blocker group
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial for Evaluating Renal Protective Effects of Antioxidants (Selenium and Vitamins A, C and E), Calcium Channel Blocker (Verapamil) and Angiotensin Receptor Blocker (Losartan) Against Extracorporeal Shock Wave Lithotripsy Induced Renal Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • Renal damage [ Time Frame: two hours and one week after Extracorporeal shock wave lithotripsy (ESWL) ] [ Designated as safety issue: Yes ]
    The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine.


Secondary Outcome Measures:
  • The mechanisms of renal protection [ Time Frame: Before ESWL, 2 hours and 1 week after ESWL ] [ Designated as safety issue: Yes ]
    The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI


Estimated Enrollment: 160
Study Start Date: July 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control group
They will recieve placebo
 Drug: Placebo
They will recieve placebo
Other Name: Placebo
Active Comparator: Antioxidant group
They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week
 Drug: Antioxidant group
They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week
Other Name: Selinium ACE
Active Comparator: Calcium channel Blockers
They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week
 Drug: Calcium Channel Blockers
They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week
Other Name: Verapamil
Active Comparator: Angiotensin receptor blocker group
They will receive Lasartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
 Drug: Angiotensin receptor blocker group
They will receive Lasartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
Other Name: Losartan

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.

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Well functioning kidney (serum creatinine <1.2 mg/dl).
  2. Solitary renal stone.
  3. Size: 15 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 <15 years).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01675362

Contacts
Contact: Khaled Z. Sheir, MD 0020502262222 ext 1623 kzsheir@hotmail.com
Contact: Ahmed R. EL-Nahas, MD 00201221136899 ar_el_nahas@yahoo.com

Locations
Egypt
Urology and Nephrology Center Recruiting
Mansoura, Egypt, 35516
Sub-Investigator: Ahmed M. Elshal, MD            
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: Ahmed R. EL-Nahas, MD Mansoura University
  More Information

No publications provided

Responsible Party: Ahmed R. EL-Nahas, Assistant Professor of Urology, Mansoura University
ClinicalTrials.gov Identifier: NCT01675362     History of Changes
Other Study ID Numbers: 4228
Study First Received: August 27, 2012
Last Updated: August 29, 2012
Health Authority: Egypt: Science and Technological Development Fund

Keywords provided by Mansoura University:
Extracorporeal shock wave lithotripsy (ESWL)
Kidney calculi
Renal protection
 Antioxidants
Calcium channel blockers
Angiotensin receptor blockers

Additional relevant MeSH terms:
Calcium, Dietary
Calcium Channel Blockers
Antioxidants
Selenium
Verapamil
Diltiazem
Losartan
Vitamin A
Vitamins
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
 Physiological Effects of Drugs
Bone Density Conservation Agents
Membrane Transport Modulators
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Trace Elements
Micronutrients
Growth Substances
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on May 23, 2013