Status:
COMPLETED
Ciclosporin A Preconditioning for Renal Artery Stenosis
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Renal Artery Stenosis
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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 dil...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- Inclusion in another study
- 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)
Key Trial Info
Start Date :
August 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03382301
Start Date
August 28 2018
End Date
June 18 2020
Last Update
May 8 2024
Active Locations (1)
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1
Service d'Exploration Fonctionnelle Rénale, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, France, 69437