NCT01675362

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

August 27, 2012

Last Update Submit

October 8, 2014

Conditions

Kidney Calculi

Keywords

Extracorporeal shockwave lithotripsy (ESWL)Kidney calculiRenal protectionAntioxidantsCalcium channel blockersAngiotensin receptor blockers

Outcome Measures

Primary Outcomes (1)

  • Renal damage

    The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine.

    two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)

Secondary Outcomes (1)

  • The mechanisms of renal protection

    Before ESWL, 2 hours and 1 week after ESWL

Study Arms (4)

Control group

PLACEBO COMPARATOR

They will receive placebo

Drug: Placebo

Antioxidant group

ACTIVE COMPARATOR

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

Calcium channel Blockers

ACTIVE COMPARATOR

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

Angiotensin receptor blocker group

ACTIVE COMPARATOR

They will receive Losartan (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

Interventions

Antioxidant groupDRUG

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

Also known as: Selenium ACE
Antioxidant group
Calcium Channel BlockersDRUG

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

Also known as: Verapamil
Calcium channel Blockers
Angiotensin receptor blocker groupDRUG

They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week

Also known as: Losartan
Angiotensin receptor blocker group
PlaceboDRUG

They will receive placebo

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Well functioning kidney (serum creatinine \<1.2 mg/dl).
  • Solitary renal stone.
  • Size: 25 mm or less in the largest diameter.

You may not qualify if:

  • Contraindications to ESWL
  • Previous surgical treatment of renal stones.
  • Congenital renal anomalies.
  • Pediatric patients (age \<18 years).
  • Patients with Diabetes or hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Kidney Calculi

Interventions

Calcium Channel BlockersVerapamilLosartan

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Membrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesCalcium-Regulating Hormones and AgentsPhysiological Effects of DrugsCardiovascular AgentsTherapeutic UsesPhenethylaminesEthylaminesAminesOrganic ChemicalsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazoles

Study Officials

  • Ahmed R. EL-Nahas, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Urology

Study Record Dates

First Submitted

August 27, 2012

First Posted

August 29, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

EG(1)