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

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.

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Failure With Renal Transplant
• Intervention / Treatment: Device: CDC solution; Device: UW-solution

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029-HUS
    • Recruiting
    • Helsinki University Central Hospital
    • Principal Investigator: Kaija Salmela, Docent
    • Sub-Investigator: Jakob Stenman, MD, PhD
    • Sub-Investigator: Marko Lempinen, MD, PhD
    • Sub-Investigator: Lauri Kyllönen, Docent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CDC graft perfusion; Flushing of kidney allografts prior to transplantation with UW-solution containing CDC	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; Other Names: Curcumin-cyclodextrin
Sham Comparator: Sham perfusion	Device: UW-solution; 500 ml of UW solution is used for flushing the kidney allograft prior to transplantation; Other Names: Viaspan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Delayed Graft Function	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Primary non-function	1 year
Acute rejection	1 year
Graft function eGFR	30 days, 90 days
Graft Survival	1 year
Patient Survival	1 year
Length of stay in hospital	upto 1 year

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: University of Helsinki; Academy of Finland
• Investigators: Principal Investigator: Kaija Salmela, Docent, Head of Kidney Transplantation Unit

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: January 26, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 28, 2011

Study Record Updates

• Last Update Posted (Estimate): January 28, 2011
• Last Update Submitted That Met QC Criteria: January 26, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Pharmaceutical Solutions; Curcumin
• Other Study ID Numbers: 236153 (Registry Identifier: Hospital District of Helsinki and Uusimaa)