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

Helsinki University Central Hospital (HUCH)

Status and phase: Unknown; Phase 1

Conditions: End Stage Renal Failure With Renal Transplant

Treatments: Device: CDC solution; Device: UW-solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01285375

236153 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ESRD assigned for kidney transplantation, written informed consent

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

CDC graft perfusion

Active Comparator group

Description:

Flushing of kidney allografts prior to transplantation with UW-solution containing CDC

Treatment:

Device: CDC solution

Sham perfusion

Sham Comparator group

Treatment:

Device: UW-solution