The TOGETHER Project - Kidney RNA-seq Validation
TOGETHER
The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients-RNA-seq Signature Validation
1 other identifier
observational
302
1 country
3
Brief Summary
The researchers are trying to develop a way to measure the risk of rejection through the validation of a blood test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2016
CompletedFirst Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2019
CompletedSeptember 19, 2022
September 1, 2022
2.6 years
March 12, 2019
September 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
To validate the use of a RNA-seq based peripheral blood assay in renal transplant recipients.
The study will validate the ability of a peripheral blood assay to assess the risk of biopsy proven rejection.
3 years
Study Arms (1)
Kidney Transplant Receipients
Eligibility Criteria
Renal transplant recipients.
You may qualify if:
- Adult (\>/=18 years) renal transplant recipient.
- Patients who have given informed consent and are willing to comply with the protocol, including the use of their peripheral blood specimens and data for subsequent research.
You may not qualify if:
- Adult (\<18 years) renal transplant recipient.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (3)
Mayo Clinic
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
Biospecimen
Blood draws collected at 1 month, 4 month, 6 month, 9 months, 12 months and for cause.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 14, 2019
Study Start
November 17, 2016
Primary Completion
June 20, 2019
Study Completion
June 20, 2019
Last Updated
September 19, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share