NCT05072951

Brief Summary

An adaptive sample collection to support biomarker evaluation for kidney transplant rejection.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

September 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 11, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 29, 2021

Last Update Submit

October 8, 2021

Conditions

Graft Rejection

Outcome Measures

Primary Outcomes (1)

  • Biospecimen collection

    3 years after last enrollment

Interventions

Urine Biomarker for Kidney Transplant RejectionDIAGNOSTIC_TEST

Biomarker for active kidney transplant rejection.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and Female, at least 18 years of age with a kidney transplant prior to enrollment.

You may qualify if:

  • Ability to provide informed consent
  • Kidney Transplant

You may not qualify if:

  • Pediatric patients, under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Urine

Study Officials

  • Sonia Kumar

    Exosome Diagnostics, Inc.

    STUDY CHAIR

Central Study Contacts

Sonia Kumar, PhD

CONTACT

7816939600Sonia.Kumar@bio-techne.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 11, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2025

Last Updated

October 11, 2021

Record last verified: 2021-09