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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285375
Recruitment Status : Unknown
Verified January 2011 by Helsinki University Central Hospital.
Recruitment status was:  Recruiting
First Posted : January 28, 2011
Last Update Posted : January 28, 2011
Helsinki University
Academy of Finland
Information provided by:
Helsinki University Central Hospital

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.

Condition or disease Intervention/treatment Phase
End Stage Renal Failure With Renal Transplant Device: CDC solution Device: UW-solution Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

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 Name: 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 Name: Viaspan

Primary Outcome Measures :
  1. Delayed Graft Function [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Primary non-function [ Time Frame: 1 year ]
  2. Acute rejection [ Time Frame: 1 year ]
  3. Graft function eGFR [ Time Frame: 30 days, 90 days ]
  4. Graft Survival [ Time Frame: 1 year ]
  5. Patient Survival [ Time Frame: 1 year ]
  6. Length of stay in hospital [ Time Frame: upto 1 year ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285375

Contact: Jakob Stenman, MD, PhD +35894711

Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029-HUS
Principal Investigator: Kaija Salmela, Docent         
Sub-Investigator: Jakob Stenman, MD, PhD         
Sub-Investigator: Marko Lempinen, MD, PhD         
Sub-Investigator: Lauri Kyllönen, Docent         
Sponsors and Collaborators
Helsinki University Central Hospital
Helsinki University
Academy of Finland
Principal Investigator: Kaija Salmela, Docent Head of Kidney Transplantation Unit

Responsible Party: Kaija Salmela, MD, Head of Kidney Transplantation Unit, Department of Liver and Transplantation Surgery Identifier: NCT01285375     History of Changes
Other Study ID Numbers: 236153
236153 ( Registry Identifier: Hospital District of Helsinki and Uusimaa )
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action