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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eplerenone group | Experimental | Eplerenone administration within 2 hours prior to patient departure to the operating room and for 4 days after kidney transplantation. |
|
| Placebo group | Placebo Comparator | Placebo administration within 2 hours prior to patient departure to the operatingroom and for 4 days after kidney transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone | Drug | Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Iohexol clearance | Graft function at 3 months evaluated by GFR using iohexol clearance | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of dialysis dependency | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric JAISSER, MD | CHRU de Nancy | Principal Investigator |
| Sophie GIRERD, MD | CHRU de NANCY | Study Chair |
| Nicolas GIRERD, MD, PhD | CHRU de Nancy | Study Chair |
| Luc FRIMAT, MD, PhD | CHRU de Nancy | Study Chair |
| Patrick ROSSIGNOL, MD, PhD | CHRU de Nancy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Besançon | Besançon | France | ||||
| CHU Brest |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39082471 | Derived | 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. | |
| 33586138 | Derived | Hasegawa 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2023 | Jun 14, 2023 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Placebo | Drug | Double-blinded Placebo administered for 4 days at 25mg every 12 hours |
|
| 7 days post transplantation |
| 24-hour proteinuria | 3 months |
| Occurrence of hyperkalemia > 6 mmol/l | 7 days post transplant |
| Length of initial hospital stay | between transplantation and discharge | 1 month |
| Proportion of patients alive | vital status collected through the national database of organ recipients | 3 months 1 year, 3 years, 10 years |
| serum creatinine | using the enzymatic method | 3 months 1 year, 3 years, 10 years |
| glomerular filtration rate | estimation using the CKD-EPI formula (in mL/min/1.73m2) | 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 | 7 days post transplant |
| Iohexol clearance < 30 mL/min/1,73m² | 3 months |
| 24-hour microalbuminuria | 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 | 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 | 3 months post transplant |
| Brest |
| France |
| CHU Dijon- Hôpital Bocage Central | Dijon | France |
| CHRU de Nancy | Nancy | France |
| CHU Reims-Hôpital Maison Blanche | Reims | France |
| CHU Saint Etienne | Saint-Etienne | France |
| NHC -CHRU Strasbourg | Strasbourg | France |
| 30376884 | Derived | Girerd 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |