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

NCT ID: NCT01285375

Last Updated: 2011-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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End Stage Renal Failure With Renal Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CDC graft perfusion

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

Group Type ACTIVE_COMPARATOR

CDC solution

Intervention Type DEVICE

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

Sham perfusion

Group Type SHAM_COMPARATOR

UW-solution

Intervention Type DEVICE

500 ml of UW solution is used for flushing the kidney allograft prior to transplantation

Interventions

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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

Intervention Type DEVICE

UW-solution

500 ml of UW solution is used for flushing the kidney allograft prior to transplantation

Intervention Type DEVICE

Other Intervention Names

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Curcumin-cyclodextrin Viaspan

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

Academy of Finland

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Liver and Transplantation Surgery

Principal Investigators

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Kaija Salmela, Docent

Role: PRINCIPAL_INVESTIGATOR

Head of Kidney Transplantation Unit

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Jakob Stenman, MD, PhD

Role: CONTACT

Phone: +35894711

Email: [email protected]

Other Identifiers

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236153

Identifier Type: REGISTRY

Identifier Source: secondary_id

236153

Identifier Type: -

Identifier Source: org_study_id