Chronic Kidney InsufficiencyPhase 2EpleCsATNCT01834768
EPLErenone in CsA-Treated Recipients (EpleCsAT): Safety
A Phase 2 study testing Eplerenone in people with Chronic Kidney Insufficiency and Kidney Transplantation, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Insufficiency, Kidney Transplantation
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Philippe RIEU contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Reims
Reims, 51092
Philippe RIEU, PhD, MD, prieu@chu-reims.fr
Philippe RIEU, PhD, MD
About this study
Official title: Study of the Safety of Eplerenone in Cyclosporine A-treated Transplant Recipients
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.
Read more
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.
- Being tested
- Eplerenone
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Eplerenone Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of an adverse event requiring the discontinuation of eplerenone
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney InsufficiencyStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834768
- Sponsor's protocol ID
- PA11020
- Acronym
- EpleCsAT
- Status last verified
- Apr 2013
- First submitted
- 11 Apr 2013
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bertocchio JP, Barbe C, Lavaud S, Toupance O, Nazeyrollas P, Jaisser F, Rieu P. Safety of Eplerenone for Kidney-Transplant Recipients with Impaired Renal Function and Receiving Cyclosporine A. PLoS One. 2016 Apr 18;11(4):e0153635. doi: 10.1371/journal.pone.0153635. eCollection 2016.
PubMed 27088859
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety of Eplerenone in Cyclosporine A-treated Transplant Recipients
- ClinicalTrials.gov ID
- NCT01834768
- Acronym / sponsor ID
- EpleCsAT / PA11020
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 Apr 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: EplerenoneEplerenone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Eplerenone | Drug | A |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
- Derived from this study: PubMed 27088859Bertocchio JP, Barbe C, Lavaud S, Toupance O, Nazeyrollas P, Jaisser F, Rieu P. Safety of Eplerenone for Kidney-Transplant Recipients with Impaired Renal Function and Receiving Cyclosporine A. PLoS One. 2016 Apr 18;11(4):e0153635. doi: 10.1371/journal.pone.0153635. eCollection 2016.
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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.
Philippe RIEU contact
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 Eplerenone in people with Chronic Kidney Insufficiency and Kidney Transplantation, run by CHU de Reims 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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 18 Apr 2013. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe RIEU (prieu@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of an adverse event requiring the discontinuation of eplerenone (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01834768, which also lists 1 linked publication.
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 18 Apr 2013.