Renal Artery StenosisPhase 2CicloSAARNCT03382301
Ciclosporin A Preconditioning for Renal Artery Stenosis
A Phase 2 study testing Ciclosporin A preconditioning before renal artery stenosis dilation and NaCl preconditioning before renal artery stenosis dilation in people with Renal Artery Stenosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Renal artery stenosis is one the leading cause of secondary hypertension. Previous randomized controlled trials in humans have failed to demonstrate an improvement of renal function after stenosis dilation, probably because of a selection bias with more severe patients being excluded from randomization. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Renal Artery Stenosis
- What is being tested?
- Ciclosporin A preconditioning before renal artery stenosis dilation and NaCl preconditioning before renal artery stenosis dilation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2018to 18 Jun 2020
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 50 years of age
- For women : only menopausal women
- Estimated Glomerular filtration rate ≥ 25 mL/min/1.73m2
- Renal artery stenosis with ≥ 70 % caliber reduction (Doppler or scanner or MRI)
- No controlateral stenosis
- Kidney size ≥ 7 cm
Show all 21Show fewer
- Only atheromatous renal artery stenosis
- Resistant hypertension and/or rapid loss of kidney function and/or flash pulmonary edema
- Collective decision of dilation after a multidisciplinary meeting
- Protected adults
- Person without a social security coverage
- Imprisoned person
- Systolic blood pressure >180 mmHg and/or diastolic blood pressure > 110 mmHg
- Non atheromatous renal artery stenosis
- Single kidney
- Multiple myeloma
- Iodine contrast agents allergy
- Ciclosporin A hypersensibility
- Severe other medical conditions that could be exacerbated by Iodine injection (cancer, lymphoma, active Hepatitis B, active Hepatitis C, uncontrolled HIV)
- Previous radiation exposure (above 20 mSv (millisievert) in the last 6 months before inclusion)
- MRI contra indications (MRI incompatible pacemaker or insulin pomp, metal clip, MRI incompatible cardiac valve, dental brace, claustrophobia)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Exploration Fonctionnelle Rénale, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69437
About this study
Official title: Impact of a Ciclosporin A Preconditioning for Prevention of Ischemia-reperfusion Injury After Renal Artery Stenosis Dilation
Renal artery stenosis is one the leading cause of secondary hypertension. Previous randomized controlled trials in humans have failed to demonstrate an improvement of renal function after stenosis dilation, probably because of a selection bias with more severe patients being excluded from randomization. Renal ischemia-reperfusion injuries have also not been taken into account. Indeed, reperfusion leads to a rapid renal blood flow recovery associated with renal ischemia-reperfusion injuries.
Mitochondrial permeability transition pore (mPTP) is a key player in the occurrence of ischemia reperfusion injuries because its opening leads to mitochondria leakage and cell death. However, preconditioning whether pharmacological or ischemic can prevent mPTP opening and protect cells. Ciclosporin A can prolong mPTP closing during reperfusion and reduce renal and cardiac tissular lesions. Another mPTP blocker (Bendavia) has been associated with an improvement of renal blood flow (RBF) and glomerular filtration rate (GFR) after renal artery stenosis dilation at 6 weeks in pigs. Based on a recent study, dilation overall benefit could be secondary to an improvement of the contralateral kidney GFR and tissue oxygen content, requiring a single kidney evaluation of those renal functional parameters. The investigators previously demonstrated that dose and timing of ciclosporin A preconditioning is key to protect kidneys from ischemia-reperfusion injuries. Previous controlled trials that failed to demonstrate a benefit of ciclosporin A conditioning have used post conditioning on necrotic cells. Considering kidney ischemia-reperfusion injuries, preconditioning have led to more encouraging results compared to ciclosporin A post conditioning in animals. Therefore the investigators aim to conduct the first clinical study of ciclosporin A preconditioning for prevention of kidney ischemia-reperfusion injuries after renal artery stenosis dilation.
Using renal functional imaging and the new PET-MRI (Positron Emission Tomography-Magnetic Resonance Imaging) combined device, the investigators will evaluate kidney perfusion, oxidative metabolism, glomerular filtration rate and oxygen content before and 3 months after renal artery stenosis dilation with or without a ciclosporin A preconditioning.
- Conditions
- Renal Artery Stenosis
- Being tested
- Ciclosporin A preconditioning before renal artery stenosis dilation, NaCl preconditioning before renal artery stenosis dilation
- Keywords
- Ischemia reperfusion injuries, Renal artery stenosis, Renal functional imaging
- Medical subject headings
- Renal Artery Obstruction, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciclosporin A preconditioning before renal artery stenosis dilationDrug
Ciclosporin A perfusion (2.5 mg/kg) for 1 hour before renal artery dilation
NaCl preconditioning before renal artery stenosis dilationDrug
NaCl perfusion (Saline perfusion) for 1 hour (2.5 mg/kg) before renal artery dilation
| Study group | Role | What they receive |
|---|---|---|
| Ciclosporin A preconditioning | Experimental | Ciclosporin A preconditioning before renal artery stenosis dilation Receives: Drug: Ciclosporin A preconditioning before renal artery stenosis dilation |
| NaCl preconditioning | Placebo comparator | Not described Receives: Drug: NaCl preconditioning before renal artery stenosis dilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in relative increase (baseline and 3 months after) of global renal perfusion between the two groups
Global renal perfusion is assessed by 15O labeled water PET (Positron Emission Tomography) imaging
Measured: 3 months after renal artery stenosis dilation
Secondary outcomes (4)
Difference in the relative increase (baseline and 3 months after) of global renal oxidative metabolism between the two groups
Global renal oxidative metabolism is assessed by 11C labeled acetate PET (Positron Emission Tomography) imaging
Measured: 3 months after renal artery stenosis dilation
Difference in the relative increase (baseline and 3 months after) of global renal oxygen content between the two groups
Global renal oxygen content is assessed by BOLD MRI (Blood-Oxygen-Level Dependent Magnetic Resonance Imaging)
Measured: 3 months after renal artery stenosis dilation
Difference in the relative increase (baseline and 3 months after) of global glomerular filtration rate between the two groups
Global glomerular filtration rate is assessed by Iohexol measured clearance
Measured: 3 months after renal artery stenosis dilation
Difference in the relative increase (baseline and 3 months after) of single-kidney perfusion (ischemic versus contralateral kidney) between the two groups
Kidney perfusion is assessed by 15O labeled water PET (Positron Emission Tomography) imaging
Measured: 3 months after renal artery stenosis dilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start28 Aug 2018
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382301
- Sponsor's protocol ID
- 69HCL16_0823
- Other IDs
- 2017-002937-48, 2017
- Acronym
- CicloSAAR
- Status last verified
- May 2024
- First submitted
- 13 Dec 2017
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Ciclosporin A Preconditioning for Prevention of Ischemia-reperfusion Injury After Renal Artery Stenosis Dilation
- ClinicalTrials.gov ID
- NCT03382301
- Acronym / sponsor ID
- CicloSAAR / 69HCL16_0823
- Conditions
- Renal Artery Stenosis
- Keywords
- Ischemia reperfusion injuries, Renal artery stenosis, Renal functional imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 22 Dec 2017 (actual)
- 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.
Renal artery stenosis is one the leading cause of secondary hypertension. Previous randomized controlled trials in humans have failed to demonstrate an improvement of renal function after stenosis dilation, probably because of a selection bias with more severe patients being excluded from randomization. Renal ischemia-reperfusion injuries have also not been taken into account. Indeed, reperfusion leads to a rapid renal blood flow recovery associated with renal ischemia-reperfusion injuries.
Mitochondrial permeability transition pore (mPTP) is a key player in the occurrence of ischemia reperfusion injuries because its opening leads to mitochondria leakage and cell death. However, preconditioning whether pharmacological or ischemic can prevent mPTP opening and protect cells. Ciclosporin A can prolong mPTP closing during reperfusion and reduce renal and cardiac tissular lesions. Another mPTP blocker (Bendavia) has been associated with an improvement of renal blood flow (RBF) and glomerular filtration rate (GFR) after renal artery stenosis dilation at 6 weeks in pigs. Based on a recent study, dilation overall benefit could be secondary to an improvement of the contralateral kidney GFR and tissue oxygen content, requiring a single kidney evaluation of those renal functional parameters. The investigators previously demonstrated that dose and timing of ciclosporin A preconditioning is key to protect kidneys from ischemia-reperfusion injuries. Previous controlled trials that failed to demonstrate a benefit of ciclosporin A conditioning have used post conditioning on necrotic cells. Considering kidney ischemia-reperfusion injuries, preconditioning have led to more encouraging results compared to ciclosporin A post conditioning in animals. Therefore the investigators aim to conduct the first clinical study of ciclosporin A preconditioning for prevention of kidney ischemia-reperfusion injuries after renal artery stenosis dilation.
Using renal functional imaging and the new PET-MRI (Positron Emission Tomography-Magnetic Resonance Imaging) combined device, the investigators will evaluate kidney perfusion, oxidative metabolism, glomerular filtration rate and oxygen content before and 3 months after renal artery stenosis dilation with or without a ciclosporin A preconditioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciclosporin A preconditioning | Experimental | Drug: Ciclosporin A preconditioning before renal artery stenosis dilationCiclosporin A preconditioning before renal artery stenosis dilation |
| NaCl preconditioning | Placebo comparator | Drug: NaCl preconditioning before renal artery stenosis dilation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients over 50 years of age
- For women : only menopausal women
- Estimated Glomerular filtration rate ≥ 25 mL/min/1.73m2
- Renal artery stenosis with ≥ 70 % caliber reduction (Doppler or scanner or MRI)
- No controlateral stenosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ciclosporin A preconditioning before renal artery stenosis dilationCiclosporin A perfusion (2.5 mg/kg) for 1 hour before renal artery dilation | Drug | Ciclosporin A preconditioning |
| NaCl preconditioning before renal artery stenosis dilationNaCl perfusion (Saline perfusion) for 1 hour (2.5 mg/kg) before renal artery dilation | Drug | NaCl preconditioning |
Primary outcome
Difference in relative increase (baseline and 3 months after) of global renal perfusion between the two groups
Time frame: 3 months after renal artery stenosis dilation
Global renal perfusion is assessed by 15O labeled water PET (Positron Emission Tomography) imaging
4 secondary outcomes
Difference in the relative increase (baseline and 3 months after) of global renal oxidative metabolism between the two groups
Time frame: 3 months after renal artery stenosis dilation
Difference in the relative increase (baseline and 3 months after) of global renal oxygen content between the two groups
Time frame: 3 months after renal artery stenosis dilation
Difference in the relative increase (baseline and 3 months after) of global glomerular filtration rate between the two groups
Time frame: 3 months after renal artery stenosis dilation
Difference in the relative increase (baseline and 3 months after) of single-kidney perfusion (ischemic versus contralateral kidney) between the two groups
Time frame: 3 months after renal artery stenosis dilation
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 8 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ciclosporin A preconditioning before renal artery stenosis dilation and NaCl preconditioning before renal artery stenosis dilation in people with Renal Artery Stenosis, run by Hospices Civils de Lyon at 1 site in France.
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 21 inclusion and 0 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 8 May 2024. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Difference in relative increase (baseline and 3 months after) of global renal perfusion between the two groups (time frame: 3 months after renal artery stenosis dilation). 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 8 May 2024.