A Phase 2 interventional study of Ciclosporin A preconditioning before renal artery stenosis dilation and NaCl preconditioning before renal artery stenosis dilation in Renal Artery Stenosis, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Hospices Civils de Lyon · Phase 2, Interventional, and Prevention
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.
59 studies on the registry are indexed under Renal Artery Obstruction; 10 are open to participants now.
This study's enrollment of 5 is below the median of 100 across 42 interventional studies indexed under Renal Artery Obstruction.
Browse Renal Artery Obstruction studies →Hospices Civils de Lyon is the lead sponsor of 1,867 studies on the registry; 448 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ciclosporin A preconditioning before renal artery stenosis dilation
Drug: Ciclosporin A preconditioning before renal artery stenosis dilation
Drug: NaCl preconditioning before renal artery stenosis dilation
Ciclosporin A perfusion (2.5 mg/kg) for 1 hour before renal artery dilation
NaCl perfusion (Saline perfusion) for 1 hour (2.5 mg/kg) before renal artery dilation
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
Time frame: 3 months after renal artery stenosis dilation
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
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
Global renal oxygen content is assessed by BOLD MRI (Blood-Oxygen-Level Dependent Magnetic Resonance Imaging)
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
Global glomerular filtration rate is assessed by Iohexol measured clearance
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
Kidney perfusion is assessed by 15O labeled water PET (Positron Emission Tomography) imaging
Time frame: 3 months after renal artery stenosis dilation
Ran from Aug 2018 to primary completion in Jun 2020, 21 months.
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