Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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