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

End Stage Renal Failure With Renal Transplant Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01285375
• Other study ID #: 236153
• Secondary ID: 236153
• Status: Recruiting
• Phase: Phase 1
• First received: January 26, 2011
• Last updated: January 26, 2011
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2011
• Source: Helsinki University Central Hospital
• Contact: Jakob Stenman, MD, PhD
• Phone: +35894711
• Email: jakob.stenman[@]hus.fi
• Is FDA regulated: No
• Health authority: Finland: National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• End Stage Renal Failure With Renal Transplant
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Academy of Finland, Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed Graft Function		7 days	Yes
Secondary	Primary non-function		1 year	Yes
Secondary	Acute rejection		1 year	Yes
Secondary	Graft function eGFR		30 days, 90 days	No
Secondary	Graft Survival		1 year	Yes
Secondary	Patient Survival		1 year	Yes
Secondary	Length of stay in hospital		upto 1 year	No