Urine Biomarker for Kidney Transplant Rejection

Sponsor
Exosome Diagnostics, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05072951
Collaborator
(none)
750
48

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Urine Biomarker for Kidney Transplant Rejection

Study Design

Study Type:
Observational
Anticipated Enrollment :
750 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Adaptive Sample Collection to Evaluate a Biomarker for Kidney Transplant Rejection
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Biospecimen collection [3 years after last enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Ability to provide informed consent

  • Kidney Transplant

Exclusion Criteria:
  • Pediatric patients, under 18 years of age

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Exosome Diagnostics, Inc.

Investigators

  • Study Chair: Sonia Kumar, Exosome Diagnostics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Exosome Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT05072951
Other Study ID Numbers:
  • ECT2021-002
First Posted:
Oct 11, 2021
Last Update Posted:
Oct 11, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 11, 2021