End-stage Renal DiseasePhase 3EPURENCT02490904
Eplerenone in Patients Undergoing REnal Transplant (EPURE TRANSPLANT)
A Phase 3 study testing Eplerenone in people with End-stage Renal Disease, run by Central Hospital, Nancy, France at 7 sites in France.
Trial summary
Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 7 sitesFrance
- Study dates
- 19 Oct 2016to Aug 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patients older than 18 years of age
- Informed consent
- Candidate for a single or a dual kidney transplantation from an expanded criteria deceased donor ( 60 years or older or age between 50 and 59 with 2 of the 3 following criteria: cardiovascular death, history of hypertension, serum creatinine above 130µmol/L), regardless of machine perfusion and graft rank
- Chronic hemodialysis
- Affiliated to a social security system
Who cannot join
- Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)
- Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone)
- Peritoneal dialysis
- Preemptive transplantation
- Hypersensitivity or known allergy to Eplerenone or one of its excipients
- Patients with severe hepatic insufficiency (class Child-Pugh C)
Show all 15Show fewer
- Patient receiving powerful CYP3A4 inhibitors (for example itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycyn and nefazodone)
- Hypersensitivity or known allergy to iodinated contrast agents (iohexol)
- Demonstrated thyrotoxicosis
- Hypersensitivity to lactose
- HLA desensitization prior to renal transplantation
- Pregnant woman or woman without effective contraception
- Patient under judicial protection
- Patient under legal guardianship
- Participation in another biomedical study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHRU Besançon
Besançon
CHU Brest
Brest
CHU Dijon- Hôpital Bocage Central
Dijon
CHRU de Nancy
Nancy
CHU Reims-Hôpital Maison Blanche
Reims
CHU Saint Etienne
Saint-Etienne
NHC -CHRU Strasbourg
Strasbourg
About this study
Official title: Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.
Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.
- Conditions
- End-stage Renal Disease
- Being tested
- Eplerenone, Placebo
- Keywords
- Kidney transplantation, Eplerenone
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours
PlaceboDrug
Double-blinded Placebo administered for 4 days at 25mg every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone group | Experimental | Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation. Receives: Drug: Eplerenone |
| Placebo group | Placebo comparator | Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iohexol clearance
Graft function at 3 months evaluated by GFR using iohexol clearance
Measured: 3 months
Secondary outcomes (13)
Proportion of dialysis dependency
Measured: 3 months
Proportion of patients presenting a delayed graft function
The proportion of patients with a delayed graft function defined by the need for one or more dialysis sessions during the 7 days following transplantation
Measured: 7 days post transplantation
24-hour proteinuria
Measured: 3 months
Occurrence of hyperkalemia > 6 mmol/l
Measured: 7 days post transplant
Length of initial hospital stay
between transplantation and discharge
Measured: 1 month
Proportion of patients alive
vital status collected through the national database of organ recipients
Measured: 3 months 1 year, 3 years, 10 years
serum creatinine
using the enzymatic method
Measured: 3 months 1 year, 3 years, 10 years
glomerular filtration rate
estimation using the CKD-EPI formula (in mL/min/1.73m2)
Measured: 3 months 1 year, 3 years, 10 years
Proportion of patients with immediate renal recovery,
The proportion of patients with an immediate renal recovery is defined by a serum creatinine lower than 30 mg/L at 7 days post-transplant
Measured: 7 days post transplant
Iohexol clearance < 30 mL/min/1,73m²
Measured: 3 months
24-hour microalbuminuria
Measured: 3 months
Proportion of patients with a slow renal recovery
The proportion of patients with slow renal recovery is defined by serum creatinine above 30 mg/L at 7 days post-transplant without the need for dialysis
Measured: 7 days post transplant
Proportion of patients with biopsy-proven acute rejection
Proportion of patients with biopsy-proven acute rejection in the first three month after transplantation
Measured: 3 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study start19 Oct 2016
- Primary completion9 Nov 2021
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Frédéric JAISSER, MD, Principal investigator, CHRU de NancySophie GIRERD, MD, Study chair, CHRU de NANCYNicolas GIRERD, MD, PhD, Study chair, CHRU de NancyLuc FRIMAT, MD, PhD, Study chair, CHRU de NancyPatrick ROSSIGNOL, MD, PhD, Study chair, CHRU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490904
- Sponsor's protocol ID
- 2015-000956-29
- Other IDs
- 2015
- Acronym
- EPURE
- Status last verified
- Jun 2023
- First submitted
- 1 Jul 2015
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
PubMed 39082471Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
PubMed 33586138Girerd S, Frimat L, Ducloux D, Le Meur Y, Mariat C, Moulin B, Mousson C, Rieu P, Dali-Youcef N, Merckle L, Lepage X, Rossignol P, Girerd N, Jaisser F. EPURE Transplant (Eplerenone in Patients Undergoing Renal Transplant) study: study protocol for a randomized controlled trial. Trials. 2018 Oct 30;19(1):595. doi: 10.1186/s13063-018-2956-1.
PubMed 30376884
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months.
- ClinicalTrials.gov ID
- NCT02490904
- Acronym / sponsor ID
- EPURE / 2015-000956-29
- Conditions
- End-stage Renal Disease
- Keywords
- Kidney transplantation, Eplerenone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 19 Oct 2016 (actual)
- Primary completion
- 9 Nov 2021 (actual)
- Study completion
- Aug 2031 (estimated)
- First posted
- 7 Jul 2015 (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.
Assess the impact of eplerenone (initiated within 2 hours prior to patient departure to the operating room and administered for 4 days during the post-operative period) on graft function evaluated by the measurement of glomerular filtration rate at 3 months - variable strongly associated with long-term graft survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eplerenone group | Experimental | Drug: EplerenoneEplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation. |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients older than 18 years of age
- Informed consent
- Candidate for a single or a dual kidney transplantation from an expanded criteria deceased donor ( 60 years or older or age between 50 and 59 with 2 of the 3 following criteria: cardiovascular death, history of hypertension, serum creatinine above 130µmol/L), regardless of machine perfusion and graft rank
- Chronic hemodialysis
- Affiliated to a social security system
Key exclusion criteria (15 listed)
- Multiple organ transplantation (kidney and liver, kidney and heart, kidney and pancreas, kidney and lung, kidney and intestine)
- Patient receiving a graft from a donor under mineralocorticoid receptor antagonist treatment (spironolactone or eplerenone)
- Peritoneal dialysis
- Preemptive transplantation
- Hypersensitivity or known allergy to Eplerenone or one of its excipients
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 |
|---|---|---|
| EplerenoneDouble-blinded Eplerenone administered for 4 days at 25mg every 12 hours | Drug | Eplerenone group |
| PlaceboDouble-blinded Placebo administered for 4 days at 25mg every 12 hours | Drug | Placebo group |
Primary outcome
Iohexol clearance
Time frame: 3 months
Graft function at 3 months evaluated by GFR using iohexol clearance
13 secondary outcomes
Proportion of dialysis dependency
Time frame: 3 months
Proportion of patients presenting a delayed graft function
Time frame: 7 days post transplantation
24-hour proteinuria
Time frame: 3 months
Occurrence of hyperkalemia > 6 mmol/l
Time frame: 7 days post transplant
Length of initial hospital stay
Time frame: 1 month
Proportion of patients alive
Time frame: 3 months 1 year, 3 years, 10 years
serum creatinine
Time frame: 3 months 1 year, 3 years, 10 years
glomerular filtration rate
Time frame: 3 months 1 year, 3 years, 10 years
Proportion of patients with immediate renal recovery,
Time frame: 7 days post transplant
Iohexol clearance < 30 mL/min/1,73m²
Time frame: 3 months
24-hour microalbuminuria
Time frame: 3 months
Proportion of patients with a slow renal recovery
Time frame: 7 days post transplant
Proportion of patients with biopsy-proven acute rejection
Time frame: 3 months post transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 39082471Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.
- Derived from this study: PubMed 33586138Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
- Derived from this study: PubMed 30376884Girerd S, Frimat L, Ducloux D, Le Meur Y, Mariat C, Moulin B, Mousson C, Rieu P, Dali-Youcef N, Merckle L, Lepage X, Rossignol P, Girerd N, Jaisser F. EPURE Transplant (Eplerenone in Patients Undergoing Renal Transplant) study: study protocol for a randomized controlled trial. Trials. 2018 Oct 30;19(1):595. doi: 10.1186/s13063-018-2956-1.
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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.
Frédéric JAISSER, MD principal investigator
CHRU de Nancy
Sophie GIRERD, MD study chair
CHRU de NANCY
Nicolas GIRERD, MD, PhD study chair
CHRU de Nancy
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eplerenone in people with End-stage Renal Disease, run by Central Hospital, Nancy, France at 7 sites 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 5 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iohexol clearance (time frame: 3 months). 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 NCT02490904, which also lists 3 linked publications.
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 Jun 2023.