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Trial record 13 of 112 for:    EPLERENONE

EPLErenone in CsA-Treated Recipients (EpleCsAT): Safety (EpleCsAT)

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ClinicalTrials.gov Identifier: NCT01834768
Recruitment Status : Unknown
Verified April 2013 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : April 18, 2013
Last Update Posted : April 18, 2013
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:

Kidney transplant recipients usually lose their graft by rejection or by immunosuppressive drugs toxicity. In kidney transplantation, calcineurin-inhibitors (including cyclosporine A) are widely used. Their renal toxicity could be divided between an acute toxicity (toxic arteriolopathy and toxic tubulopathy) and a chronic toxicity (hyaline arteriolopathy, interstitial fibrosis, tubular atrophy and glomerulosclerosis). Several animal models have shown the implication of the mineralocorticoid receptor (MR) activation in those toxic phenomenons. The use of a mineralocorticoid receptor antagonist is useful regarding to the renal function and kidney histological damages.

Several antagonists are available in France but none is indicated in kidney transplantation. Eplerenone appears to be the most selective molecule of the mineralocorticoid receptor and to have less adverse anti-androgenic effects than others molecules. Its principal adverse events are hyperkalemia and orthostatic hypotension. Mineralocorticoid receptor antagonists, especially eplerenone, could be very useful in the prevention of the nephrotoxicity induced by calcineurin-inhibitors.

Classically, eplerenone is contra-indicated in patients presenting with an impaired renal function, determined by a creatinine clearance under 50mL/min. Moreover, in France, a warning is especially notified for the association with cyclosporine A due to the fact that no study have been done in this context.

The investigators study first the safety of the use of eplerenone in association with cyclosporine A in kidney transplant recipients. Then, if it is safe, the investigators will study its efficiency in a large randomized controlled trial.


Condition or disease Intervention/treatment Phase
Chronic Kidney Insufficiency Kidney Transplantation Drug: Eplerenone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Safety of Eplerenone in Cyclosporine A-treated Transplant Recipients
Study Start Date : February 2013
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: A
Eplerenone
Drug: Eplerenone



Primary Outcome Measures :
  1. Occurence of an adverse event requiring the discontinuation of eplerenone [ Time Frame: 8 weeks ]

    Occurrence of an adverse event requiring the discontinuation of eplerenone:

    • serum potassium higher than or equal to 6mmol/L and/or higher than or equal to 5.5mmol/L under 2 measuring spoons of KAYEXALATE®
    • acidosis evidenced by serum alkaline reserve lower than or equal to 15mmol/L
    • systemic hypotension evidenced by a systolic blood pressure lower than 100mHg
    • orthostatic hypotension evidenced by a decrease of systolic blood pressure more than 20mmHg to the transition to upright posture within 3 minutes
    • acute kidney failure evidenced by an increase of serum creatinine more than 30% from the starting value (at the date of inclusion)
    • every other adverse event unscheduled by investigators, only if it requires the discontinuation of eplerenone



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All the patients that will be included in this trial have to fulfil all the following conditions:

  • more than 18-years old at the date of inclusion
  • a full legal capacity
  • belonging to a health care system
  • give their written consent
  • a functional kidney allograft for at least 1 year from the date of inclusion
  • be under cyclosporine A-treatment
  • impaired renal function estimated by the MDRD formula between 30 to 50mL/min/1.73m²

Exclusion Criteria:

All the patients that will be included in this trial have to fulfil no one of the following conditions:

  • serum potassium higher than or equal to 5mmol/L at the date of inclusion
  • one or more history of severe hyperkalemia (serum potassium higher than or equal to 6mmol/L) whatever the reason
  • currently under potassium exchange resin treatment like KAYEXALATE®
  • an acute rejection of the graft within the 6 months before the date of inclusion
  • an ongoing pregnancy or a lack of effective contraception during all the study
  • an uncontrolled high arterial blood pressure
  • an orthostatic hypotension
  • a systolic arterial blood pressure under or equal to 110mmHg
  • a heart failure within the past 3 months before the date of inclusion or a chronic heart failure (stages III or IV of the NYHA classification)
  • a severe hepatic failure (stage C of the Child-Pugh classification)
  • an allergy to one or more of the components of the speciality eplerenone - INSPRA®
  • an ongoing treatment with spironolactone - ALDACTONE® or eplerenone - INSPRA®
  • a contra-indicated association whose treatment could not be suspended during the study: potassium sparing diuretics, potassium salts, enzymatic inhibitors of CYP3A4 (like itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycine, telithromycine, nefazodone)
  • a malabsorption syndrome, an abnormality of galactose metabolism or a deficiency in galactase
  • an ongoing treatment with nonsteroidal anti-inflammatory or with lithium or another nephrotoxic agent
  • an ongoing treatment with a double-blockade of the Renin-Angiotensin-Aldosterone System by the association ACE-I (Angiotensin-Converting Enzyme Inhibitor) and ARB (Angiotensin Receptor Blocker)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834768


Contacts
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Contact: Philippe RIEU prieu@chu-reims.fr

Locations
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France
Centre Hospitalier Universitaire de Reims Recruiting
Reims, France, 51092
Contact: Philippe RIEU, PhD, MD       prieu@chu-reims.fr   
Principal Investigator: Philippe RIEU, PhD, MD         
Sponsors and Collaborators
CHU de Reims
Institut National de la Santé Et de la Recherche Médicale, France

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT01834768     History of Changes
Other Study ID Numbers: PA11020
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Eplerenone
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents