Desensitization Protocol for Deceased Donor List

Transplant; Failure, Kidney Clinical Trial

Official title:

Desensitization Protocol for Deceased Donor List

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642225
• Other study ID #: 20120052
• Status: Completed
• Phase: N/A
• First received: July 12, 2012
• Last updated: October 17, 2014
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Purpose of the study:

The specific aims of this study are to evaluate overall efficacy and safety of the pre-transplant IVIG treatment in our transplant center since 2007 and to identify factors affecting treatment outcomes in order to improve patient selection and treatment protocols for future patients.

Description:

Background:

Intravenous immunoglobulin (IVIG) infusion is one of several novel approaches to decrease antibody levels for highly sensitized kidney transplant candidates [1, 2]. This approach can potentially give a chance of kidney transplantation to end-stage renal failure patients who could never receive transplantation because of high levels of antibodies and persistent positive crossmatches to all potential kidney donors. Many transplant centers have used this strategy in order to increase transplant rates of highly sensitized patients with various levels of anti-HLA antibodies. However, the responses to the treatment seem to be different in each patient and factors affecting treatment outcome have yet to be determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 75 Years

Eligibility

Inclusion Criteria:

• Recent (< 3 months) high levels of anti-HLA antibodies (at least one cPRA = 40%).

• Waiting time greater than 1 year for blood type AB, 2 years for blood types A, B, or O.

Exclusion Criteria:

• Female subject is pregnant or lactating.

• Subject has an uncontrolled concomitant infection or any other unstable medical condition (e.g., uncontrolled cardiovascular disease) that could interfere with the study objectives.

• Subject has an uncontrolled active hepatitis B, hepatitis C, or HIV infection.

• Subject has a current malignancy or a recent history of any malignancy that is deemed to be contraindicated to kidney transplantation.

• Subject has a psychiatric illness that, in the judgment of caring physicians, may interfere with study participation.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Renal Insufficiency
• Transplant; Failure, Kidney

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti HLA antibody level		after IVIG infusion	No
Secondary	Number of patients transplanted		at the end of study	No