NCT01285375

Safety and Preliminary Efficacy of the Treatment of Kidney Allografts With Curcumin-containing Preservation Solution

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Failure With Renal Transplant

Interventions

Type	Name	Description
DEVICE	CDC 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
DEVICE	UW-solution	500 ml of UW solution is used for flushing the kidney allograft prior to transplantation

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-01-28
• Last updated: 2011-01-28

Locations

1 site across 1 country: Finland