Safety and Preliminary Efficacy of the Treatment of Kidney Allografts With Curcumin-containing Preservation Solution
Phase 1
- Conditions
- End Stage Renal Failure With Renal Transplant
- Interventions
- Device: CDC solutionDevice: UW-solution
- Registration Number
- NCT01285375
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Patients with ESRD assigned for kidney transplantation, written informed consent
Exclusion Criteria
- None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CDC graft perfusion CDC solution Flushing of kidney allografts prior to transplantation with UW-solution containing CDC Sham perfusion UW-solution -
- Primary Outcome Measures
Name Time Method Delayed Graft Function 7 days
- Secondary Outcome Measures
Name Time Method Primary non-function 1 year Acute rejection 1 year Graft function eGFR 30 days, 90 days Graft Survival 1 year Patient Survival 1 year Length of stay in hospital upto 1 year
Trial Locations
- Locations (1)
Helsinki University Central Hospital
🇫🇮Helsinki, Finland