Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00611702




Registration number
NCT00611702
Ethics application status
Date submitted
7/02/2008
Date registered
11/02/2008
Date last updated
14/05/2015

Titles & IDs
Public title
Genomics of Chronic Renal Allograft Rejection (The GoCAR Study)
Scientific title
Genomics of Chronic Renal Allograft Rejection
Secondary ID [1] 0 0
DAIT GTCRP-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - Kidney biopsy

Treatment: Surgery: Kidney biopsy
Kidney biopsy (recipients only) will be obtained for RT-PCR, microarray analyses and histology.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Correlation of chronic rejection with patterns and intensity of recipient alloreactivity
Timepoint [1] 0 0
Throughout study
Primary outcome [2] 0 0
Correlation of chronic rejection with recipient gene expression profiles
Timepoint [2] 0 0
Throughout study
Primary outcome [3] 0 0
Correlation of chronic rejection with polymorphic variants of specific susceptibility genes in donor and recipient
Timepoint [3] 0 0
Throughout study
Secondary outcome [1] 0 0
Correlation of the development of donor specific antibodies after transplant and/or the presence of C4d staining with patterns and intensity of recipient alloreactivity
Timepoint [1] 0 0
Throughout study
Secondary outcome [2] 0 0
Correlation of the development of donor specific antibodies after transplant and/or the presence of C4d staining with recipient gene expression profiles
Timepoint [2] 0 0
Throughout study
Secondary outcome [3] 0 0
Correlation of the development of donor-specific antibodies after transplant and/or the presence of C4d staining of peritubular basement membranes on renal biopsy with polymorphic variants of specific susceptibility genes in donor and recipient
Timepoint [3] 0 0
Throughout study
Secondary outcome [4] 0 0
Correlation of the development of donor-specific antibodies after transplant and/or the presence of C4d staining of peritubular basement membranes on renal biopsy with chronic rejection
Timepoint [4] 0 0
Throughout study
Secondary outcome [5] 0 0
Correlation of the development of donor-specific antibodies after transplant and/or the presence of C4d staining of peritubular basement membranes on renal biopsy allograft dysfunction as defined by the protocol
Timepoint [5] 0 0
Throughout study

Eligibility
Key inclusion criteria
* Kidney transplant candidates from living or deceased donors
* Male or female, ages 18-75 years
* Subject must be able to understand and provide written informed consent
* Living Donors - Recipient also consents to participate in the study
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of Donor Specific Antibodies in living donor recipients prior to transplantation OR positive cross match according to site-specific technique in cadaveric donor recipients
* Recipients of multiple organ transplants, with the exception of kidney/pancreas transplants.
* Inability or unwillingness to comply with the study protocol.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
588
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Government body
Name
National Institute of Allergy and Infectious Diseases (NIAID)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbara T. Murphy, MD
Address 0 0
Division of Nephrology, Mt. Sinai School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00611702