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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Helsinki University Central Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Helsinki University
Academy of Finland
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01285375
First received: January 26, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose
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 Intervention Phase
End Stage Renal Failure With Renal Transplant
Device: CDC solution
Device: UW-solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Delayed Graft Function [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Primary non-function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Acute rejection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Graft function eGFR [ Time Frame: 30 days, 90 days ] [ Designated as safety issue: No ]
  • Graft Survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Patient Survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Length of stay in hospital [ Time Frame: upto 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285375

Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029-HUS
Sponsors and Collaborators
Helsinki University Central Hospital
Helsinki University
Academy of Finland
Investigators
Principal Investigator: Kaija Salmela, Docent Head of Kidney Transplantation Unit
  More Information

Responsible Party: Kaija Salmela, MD, Head of Kidney Transplantation Unit, Department of Liver and Transplantation Surgery
ClinicalTrials.gov Identifier: NCT01285375     History of Changes
Other Study ID Numbers: 236153  236153 
Study First Received: January 26, 2011
Last Updated: January 26, 2011
Health Authority: Finland: National Supervisory Authority for Welfare and Health

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on December 05, 2016