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

Primary Purpose

End Stage Renal Failure With Renal Transplant

Status

Unknown status

Phase

Phase 1

Locations

Finland

Study Type

Interventional

Intervention

CDC solution

UW-solution

About this trial

This is an interventional prevention trial for End Stage Renal Failure With Renal Transplant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with ESRD assigned for kidney transplantation, written informed consent

Exclusion Criteria:

None

Sites / Locations

Helsinki University Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

CDC graft perfusion

Sham perfusion

Arm Description

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

Outcomes

Primary Outcome Measures

Delayed Graft Function

Secondary Outcome Measures

Primary non-function

Acute rejection

Graft function eGFR

Graft Survival

Patient Survival

Length of stay in hospital

Full Information

NCT ID

NCT01285375

First Posted

January 26, 2011

Last Updated

January 26, 2011

Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki, Academy of Finland

1. Study Identification

Unique Protocol Identification Number

NCT01285375

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Helsinki University Central Hospital

Collaborators

University of Helsinki, Academy of Finland

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Failure With Renal Transplant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CDC graft perfusion

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham perfusion

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

CDC solution

Other Intervention Name(s)

Curcumin-cyclodextrin

Intervention Description

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

Intervention Name(s)

UW-solution

Other Intervention Name(s)

Viaspan

Intervention Description

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

Primary Outcome Measure Information:

Title

Delayed Graft Function

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Primary non-function

Time Frame

1 year

Title

Acute rejection

Time Frame

1 year

Title

Graft function eGFR

Time Frame

30 days, 90 days

Title

Graft Survival

Time Frame

1 year

Title

Patient Survival

Time Frame

1 year

Title

Length of stay in hospital

Time Frame

upto 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with ESRD assigned for kidney transplantation, written informed consent Exclusion Criteria: None

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jakob Stenman, MD, PhD

Phone

+35894711

jakob.stenman@hus.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaija Salmela, Docent

Organizational Affiliation

Head of Kidney Transplantation Unit

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helsinki University Central Hospital

City

Helsinki

ZIP/Postal Code

00029-HUS

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaija Salmela, Docent

First Name & Middle Initial & Last Name & Degree

Jakob Stenman, MD, PhD

First Name & Middle Initial & Last Name & Degree

Marko Lempinen, MD, PhD

First Name & Middle Initial & Last Name & Degree

Lauri Kyllönen, Docent

12. IPD Sharing Statement

Learn more about this trial

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

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