The TOGETHER Project - Kidney

Kidney Transplant Rejection Clinical Trial

— TOGETHER  

Official title:

The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients With Realtime Assay Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873623
• Other study ID #: 16-003159
• Status: Completed
• Start date: November 2016
• Est. completion date: December 19, 2019

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Researchers are trying to develop a way to customize immunosuppression treatment, based on the results of a blood test that measures the risk of rejection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 19, 2019
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Conventional solitary kidney transplant (ABO compatible, crossmatch negative, not a kidney transplant simultaneously transplanted with another non-renal organ including heart, liver, lung or pancreas)

• Patients who have given informed consent and are willing to comply with the protocol, including the use of their specimens and data for subsequent research.

Exclusion Criteria:

• EBV -seronegative recipient

• ABO incompatible kidney transplants.

• Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, bone marrow transplantation, etc or prior recipient of non-renal transplant. Subjects who had previous extra renal transplants may be included in the study.

• Positive crossmatch kidney transplants (T cell crossmatch >100, B flow cytometric crossmatch >150).

• Participating in other clinical trials

• Any kidney transplant recipient < 18 years of age.

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To correlate the findings of TruGraf (a peripheral blood RNA signature that has been shown to correlate with rejection in renal allografts) with rejection episodes in renal transplant patients .	The study will validate the ability of a peripheral blood assay to assess the risk of rejection and determine the role this assay will have in immunosuppression monitoring in our patients at Mayo Clinic (3 sites).	3 years

External Links

•   Mayo Clinic Clinical Trials