Cyclosporine a Pretreatment and Kidney Graft Function (Cis-A-Rein)
Effects of Cyclosporine a Pretreatment of Deceased Donor on Kidney Graft Function: a Randomized Controlled Trial
Sponsor: Centre Hospitalier Universitaire de Nice
Listed as NCT02907554, this PHASE4 trial focuses on Brain Death and Kidney Transplantation and remains completed. Sponsored by Centre Hospitalier Universitaire de Nice, it has been updated 11 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)Organ donors included in the study are randomized to a control group receiving a placebo or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. In the operating theater organs are harvested. Thereafter, harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. The management of transplanted patients is performed as usual. According to the pretreatment of the transplant, delayed graft function during the first week (need of at least one dialysis session) was evaluated as well as kidney function at different timepoints (slow graft function, estimated creatinine clearance on day 3 and 7, acute and chronic graft rejection), length of hospital stay and mortality during the first year after transplantation.
Organ donors included in the study are randomized to a control group receiving a placebo or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. In the operating theater organs are harvested. Thereafter, harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. The management of transplanted patients is performed as usual. According to the pretreatment of the transplant, delayed graft function during the first week (need of at least one dialysis session) was evaluated as well as kidney function at different timepoints (slow graft function, estimated creatinine clearance on day 3 and 7, acute and chronic graft rejection), length of hospital stay and mortality during the first year after transplantation.
Status Flow
Change History
11 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE4
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Jan 2025 — Present [monthly]
Completed PHASE4
Status: Unknown → Completed
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Sep 2024 — Jan 2025 [monthly]
Unknown PHASE4
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Jul 2024 — Sep 2024 [monthly]
Unknown PHASE4
Status: Unknown Status → Unknown
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Nov 2022 — Jul 2024 [monthly]
Unknown Status PHASE4
Status: Recruiting → Unknown Status
▶ Show 6 earlier versions
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Jan 2021 — Nov 2022 [monthly]
Recruiting PHASE4
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Aug 2020 — Jan 2021 [monthly]
Recruiting PHASE4
Status: Unknown Status → Recruiting
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Mar 2020 — Aug 2020 [monthly]
Unknown Status PHASE4
Status: Recruiting → Unknown Status
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Jun 2018 — Mar 2020 [monthly]
Recruiting PHASE4
-
Mar 2018 — Jun 2018 [monthly]
Recruiting PHASE4
Status: Not Yet Recruiting → Recruiting
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Jan 2017 — Mar 2018 [monthly]
Not Yet Recruiting PHASE4
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Centre Hospitalier Universitaire de Nice
- Centre Hospitalier Universitaire de Nīmes
- Groupe Hospitalier Pitie-Salpetriere
- Hôpital de la Timone
- Hôtel Dieu (Nantes)
- Poitiers University Hospital
- University Hospital, Clermont-Ferrand
- University Hospital, Estaing
- University Hospital, Montpellier
- University Hospital, Toulouse
For direct contact, visit the study record on ClinicalTrials.gov .