NCT01285375

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

1.9 years

First QC Date

January 26, 2011

Last Update Submit

January 26, 2011

Conditions

End Stage Renal Failure With Renal Transplant

Outcome Measures

Primary Outcomes (1)

  • Delayed Graft Function

    7 days

Secondary Outcomes (6)

  • Primary non-function

    1 year

  • Acute rejection

    1 year

  • Graft function eGFR

    30 days, 90 days

  • Graft Survival

    1 year

  • Patient Survival

    1 year

  • +1 more secondary outcomes

Study Arms (2)

CDC graft perfusion

ACTIVE COMPARATOR

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

Device: CDC solution

Sham perfusion

SHAM COMPARATOR
Device: UW-solution

Interventions

CDC solutionDEVICE

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

Also known as: Curcumin-cyclodextrin
CDC graft perfusion
UW-solutionDEVICE

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

Also known as: Viaspan
Sham perfusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029-HUS, Finland

RECRUITING

Study Officials

  • Kaija Salmela, Docent

    Head of Kidney Transplantation Unit

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob Stenman, MD, PhD

CONTACT

+35894711jakob.stenman@hus.fi

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 28, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations

FI(1)