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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003544-12 | Other Identifier | 2014-003544-12 |
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| Name | Class |
|---|---|
| University Hospital, Estaing | OTHER |
| Centre Hospitalier Universitaire de Nice | OTHER |
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
| Centre Hospitalier Universitaire de Nīmes |
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Organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. According to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Placebo Comparator | control group receives a placebo |
|
| intervention group | Experimental | the intervention group receives 2.5 mg/kg of cyclosporine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine A | Drug | the intervention group receives 2.5 mg/kg of cyclosporine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of delayed graft function defined by a need of at least one hemodialysis session | within the 7 days following renal transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of slow graft function defined by a urine output < 1000 ml | at on 1 day after transplantation | |
| Percentage of slow graft function defined by a decrease in plasma creatinine concentration of less than 30% or 70% | at day 3 and 7 after transplantation |
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Inclusion Criteria:
For organ donors:
Inclusion criteria for organ recipients:
Exclusion Criteria:
For organ donors:
Exclusion criteria for organ recipients:
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| Name | Affiliation | Role |
|---|---|---|
| Carole ICHAI | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29665840 | Derived | Orban JC, Fontaine E, Cassuto E, Baumstarck K, Leone M, Constantin JM, Ichai C; AzuRea network. Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial. Trials. 2018 Apr 17;19(1):231. doi: 10.1186/s13063-018-2597-4. |
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| ID | Term |
|---|---|
| D001926 | Brain Death |
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| OTHER |
| University Hospital, Montpellier | OTHER |
| Hôtel Dieu (Nantes) | UNKNOWN |
| Poitiers University Hospital | OTHER |
| University Hospital, Toulouse | OTHER |
| Hôpital de la Timone | OTHER |
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| Placebo |
| Drug |
control group receives a placebo |
|
| Postoperative evolution of estimated creatinine clearance | at day 3 and 7 |
| Percentage of acute and chronic graft rejection | during the first year after transplantation |
| Percentage of primary graft dysfunction | during the first year after transplantation |
| hospital length of stay | after transplantation | at day 1 |
| Mortality | during the first year after transplantation |
| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |