NCT04566055

Brief Summary

Prospective Observational Multicenter Cohort. External validation of donor derived cell free DNA in Renal Transplantation. Assessing performance of dd-cfDNA as a surveillance tool and its association with clinical outcomes. Outcomes include formation of de-novo DSA, eGFR decline, performance of AlloSure dd-cfDNA in Allograft rejection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

8 active sites

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

Study Start

First participant enrolled

March 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

1.6 years

First QC Date

September 22, 2020

Last Update Submit

September 30, 2020

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (1)

  • Validation of AlloSure in Allograft rejection

    October 2020

Secondary Outcomes (1)

  • Performance of AS with De-Novo DSAs, Performance in subclinical and protocol biopsies vs clinically indicated for cause biopsies, Survival analysis considering AS surveillance

    October 2020

Study Arms (1)

Prospective observational cohort

Device: AlloSure

Interventions

AlloSureDEVICE

Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause.

Prospective observational cohort

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Renal transplant patients

You may qualify if:

  • Renal transplant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Tampa General Hosptial

Tampa, Florida, 33606, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Memorial Hermann Hosptial

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma from venous blood will be collected and cell-free DNA will be extracted from the plasma for analysis of donor-derived cell-free DNA

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2020

First Posted

September 28, 2020

Study Start

March 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations

US(8)