End Stage Renal Failure With Renal Transplant Clinical Trial
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients with ESRD assigned for kidney transplantation, written informed consent Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Central Hospital | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | Academy of Finland, Helsinki University |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delayed Graft Function | 7 days | Yes | |
Secondary | Primary non-function | 1 year | Yes | |
Secondary | Acute rejection | 1 year | Yes | |
Secondary | Graft function eGFR | 30 days, 90 days | No | |
Secondary | Graft Survival | 1 year | Yes | |
Secondary | Patient Survival | 1 year | Yes | |
Secondary | Length of stay in hospital | upto 1 year | No |
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