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| ID | Type | Description | Link |
|---|---|---|---|
| 236153 | Registry Identifier | Hospital District of Helsinki and Uusimaa |
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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
| Academy of Finland | OTHER |
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The safety and preliminary efficacy of the addition of an aqueous curcumin-cyclodextrin complex (CDC) solution to graft perfusion solution is studied. CDC has proved safe and highly effective in preventing primary graft non-function, delayed graft function and chronic dysfunction in pre-clinical kidney transplantation animal models. The hypothesis is that addition of CDC to the graft perfusion solution will decrease the incidence of delayed graft function in human kidney transplantation subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDC graft perfusion | Active Comparator | Flushing of kidney allografts prior to transplantation with UW-solution containing CDC |
|
| Sham perfusion | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDC solution | Device | 2 ml of CDC 12/mg/ml is added to 1 l of UW solution. 500 ml of of this solution is used for flushing the kidney allograft prior to transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delayed Graft Function | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Primary non-function | 1 year | |
| Acute rejection | 1 year | |
| Graft function eGFR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakob Stenman, MD, PhD | Contact | +35894711 | jakob.stenman@hus.fi |
| Name | Affiliation | Role |
|---|---|---|
| Kaija Salmela, Docent | Head of Kidney Transplantation Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Recruiting | Helsinki | 00029-HUS | Finland |
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|
| UW-solution | Device | 500 ml of UW solution is used for flushing the kidney allograft prior to transplantation |
|
|
| 30 days, 90 days |
| Graft Survival | 1 year |
| Patient Survival | 1 year |
| Length of stay in hospital | upto 1 year |