NCT03874299

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

2.6 years

First QC Date

March 12, 2019

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (3)

Mayo Clinic

Scottsdale, Arizona, United States

Location

Mayo Clinic

Jacksonville, Florida, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

Locations