CHRU de Nancy
Vandœuvre-lès-Nancy, 54500, France
Location status: Recruiting
NCT Number: NCT04450953
Cardiovascular (CV) pathologies are the leading cause of death in kidney transplant patients.Arterial stiffness is a prognostic factor for CV mortality in kidney transplantation. Despite a reduced CV risk in transplant kidney patients in comparison to patients in dialysis, CV mortality among kidney transplant patients is much higher than the general population.
After renal transplantation, the cardiac and vascular anomalies observed in chronic end-stage renal disease are partially improved because of restored normal kidney function and withdrawal from dialysis.
However, patients are exposed to immunosuppressive drugs, in particular calcineurin inhibitors, which can be associated with vascular toxicity, either directly or by promoting the appearance of hypertension, diabetes, or dyslipidemia.The pathophysiology of arterial stiffness in kidney transplantation is complex and multifactorial.
Calcineurin inhibitors are likely to play an important role in the persistence of increased arterial stiffness in transplant patients in whom renal function has been restored. Indeed, the discontinuation of anti-calcineurins in favour of other molecules .is associated with a decrease of arterial stiffness.
Preclinical work has shown that the vascular toxicity of cyclosporine is mediated by activation of the mineralocorticoid receptor in smooth muscle cells. The involvement of the mineralocorticoid receptor in the onset of arterial stiffness is also well demonstrated in non-transplanted subjects.
Blocking the mineralocorticoid receptor in patients under cyclosporine may reduce their arterial stiffness and in and consequently improve their CV prognosis.
Studies have show a good safety in kidney transplant patients. This pilot study proposes to examine, for the first time, the impact of treatment with a mineralocorticoid receptor antagonist on the evolution of arterial stiffness in renal transplant patients on calcineurin inhibitors.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Phase 3
Vandœuvre-lès-Nancy, 54500, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Eplerenone 50mg/day for 6 months followed
6-month period without eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
measured by creatinine (in micromol/L) with estimation of glomerular filtration rate (eGFR in mL/min/1.73m2 ) according to the CKD-EPI formula.
Time frame: After 6 months of treatment with eplerenone
measured by the ratio proteinuria/creatinuria (in mg/g)
Time frame: After 6 months of treatment with eplerenone
Time frame: After 6 months of treatment with eplerenone
Time frame: during 6 month of treatment with eplerenone
Time frame: during 6 month of treatment with eplerenone
number of hyperkalemias during hyperkalemia follow-up between 5 - 5.49; 5.5 - 6; >6mmol/L
Time frame: during 6 month of treatment with eplerenone
Evaluation of risk of acute renal failure defined as an increase in creatinine of more than 50%
Contact information is provided by the study sponsor or research team.
Nicolas GIRERD, MD-PhD
CONTACT
(0) 3 83 15 73 22 ext. +33
Sophie GIRERD, MD-phD
CONTACT
(0) 3 83 15 73 22 ext. +33
Central Hospital, Nancy, France
Other
A Randomized Crossover Clinical Trial Regarding the Blockage of the Mineralocorticoid Receptor Using Eplerenone on the Evolution of Arterial Stiffness in Kidney Patients One Year After Transplant
Acronym: EVATRAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.