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Double-blind Placebo-Controlled Randomized Clinical Trial of Mineralocorticoid Receptor Blockade With Eplerenone After Renal Transplantation : Effect on Graft Function at 3 Months. EPURE TRANSPLANT

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517408-12-00
Enrollment
132
Registered
2024-11-28
Start date
2024-11-28
Completion date
Unknown
Last updated
2024-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient in end-stage renal disease candidate for a kidney transplant

Brief summary

Iohexol clearance at 3 months

Detailed description

Proportion of dialysis dependency at 3 months, Proportion of patients presenting a delayed graft function at 7 days post transplantation, 24-hour proteinuria and 24-hour microalbuminuria at 3 months, Occurrence of hyperkalemia > 6 mmol/l at 7 days post transplantation, Length of initial hospital stay, Proportion of patients alive and glomerular filtration rate at 3 months 1 year, 3 years, 10 years post transplantation, Proportion of patients with biopsy-proven acute rejection at 3 months post tranplantation

Interventions

DRUGOMNIPAQUE 300 mg d'I/ml
DRUGsolution injectable
DRUGGélules de lactose monohydraté additionné de carmin de cochenille
DRUGINSPRA 50 mg
DRUGcomprimé pelliculé

Sponsors

CHRU De Nancy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Iohexol clearance at 3 months

Secondary

MeasureTime frame
Proportion of dialysis dependency at 3 months, Proportion of patients presenting a delayed graft function at 7 days post transplantation, 24-hour proteinuria and 24-hour microalbuminuria at 3 months, Occurrence of hyperkalemia > 6 mmol/l at 7 days post transplantation, Length of initial hospital stay, Proportion of patients alive and glomerular filtration rate at 3 months 1 year, 3 years, 10 years post transplantation, Proportion of patients with biopsy-proven acute rejection at 3 months post tranplantation

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026