End Stage Renal Failure With Renal Transplant
Conditions
Brief summary
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.
Interventions
DEVICECDC solution
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
DEVICEUW-solution
500 ml of UW solution is used for flushing the kidney allograft prior to transplantation
Sponsors
University of Helsinki
Academy of Finland
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with ESRD assigned for kidney transplantation, written informed consent
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed Graft Function | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Acute rejection | 1 year |
| Graft function eGFR | 30 days, 90 days |
| Primary non-function | 1 year |
| Patient Survival | 1 year |
| Length of stay in hospital | upto 1 year |
| Graft Survival | 1 year |
Countries
Finland
Contacts
Primary ContactJakob Stenman, MD, PhD
Outcome results
None listed