Kidney CalculiPhase 4SWLNCT01675362
Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?
A Phase 4 study testing Antioxidant group, Calcium Channel Blockers and Angiotensin receptor blocker group in people with Kidney Calculi, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Antioxidant group, Calcium Channel Blockers and Angiotensin receptor blocker group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2012to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Well functioning kidney (serum creatinine <1.2 mg/dl).
- Solitary renal stone.
- Size: 25 mm or less in the largest diameter.
Who cannot join
- Contraindications to ESWL
- Previous surgical treatment of renal stones.
- Congenital renal anomalies.
- Pediatric patients (age <18 years).
- Patients with Diabetes or hypertension
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Kidney Calculi
- Being tested
- Antioxidant group, Calcium Channel Blockers, Angiotensin receptor blocker group, Placebo
- Keywords
- Extracorporeal shockwave lithotripsy (ESWL), Kidney calculi, Renal protection, Antioxidants, Calcium channel blockers, Angiotensin receptor blockers
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antioxidant groupDrug
Also called Selenium ACE
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
Calcium Channel BlockersDrug
Also called Verapamil
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
Angiotensin receptor blocker groupDrug
Also called Losartan
They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
PlaceboDrug
They will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | They will receive placebo Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Angiotensin receptor blocker group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)
Secondary outcomes (1)
The mechanisms of renal protection
The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI
Measured: Before ESWL, 2 hours and 1 week after ESWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed R. EL-Nahas, Mansoura University
- Investigators
- Ahmed R. EL-Nahas, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675362
- Sponsor's protocol ID
- 4228
- Acronym
- SWL
- Status last verified
- Oct 2014
- First submitted
- 27 Aug 2012
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01675362
- Acronym / sponsor ID
- SWL / 4228
- Conditions
- Kidney Calculi
- Keywords
- Extracorporeal shockwave lithotripsy (ESWL), Kidney calculi, Renal protection, Antioxidants, Calcium channel blockers, Angiotensin receptor blockers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: PlaceboThey will receive placebo |
| Antioxidant group | Active comparator | Drug: Antioxidant groupThey 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 |
| Calcium channel Blockers | Active comparator | Drug: Calcium Channel BlockersThey will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week |
| Angiotensin receptor blocker group | Active comparator | Drug: Angiotensin receptor blocker groupThey will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Well functioning kidney (serum creatinine <1.2 mg/dl).
- Solitary renal stone.
- Size: 25 mm or less in the largest diameter.
Key exclusion criteria (5 listed)
- Contraindications to ESWL
- Previous surgical treatment of renal stones.
- Congenital renal anomalies.
- Pediatric patients (age <18 years).
- Patients with Diabetes or hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antioxidant groupAlso: Selenium ACEThey 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 BlockersAlso: VerapamilThey 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 groupAlso: LosartanThey 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 |
| PlaceboThey will receive placebo | Drug | Control group |
Primary outcome
Renal damage
Time frame: two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)
The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine.
1 secondary outcome
The mechanisms of renal protection
Time frame: Before ESWL, 2 hours and 1 week after ESWL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed R. EL-Nahas, MD principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antioxidant group, Calcium Channel Blockers and Angiotensin receptor blocker group in people with Kidney Calculi, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal damage (time frame: two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2014.