Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection

Complications Clinical Trial

— SPARO  

Official title:

Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984747
• Other study ID #: 18-038-TRP
• Status: Recruiting
• Start date: September 14, 2018
• Est. completion date: October 30, 2028

Study information

• Verified date: April 2024
• Source: Natera, Inc.
• Contact: Zach Demko, PhD
• Phone: 6502499090
• Email: zdemko[@]natera.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis, called Prospera.

Description:

This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis, called Prospera.

Subjects who have had an organ transplant, who present at the clinic for a standard of care visit or consent for an extra research blood samples to be taken by mobile phlebotomy, meet the study's eligibility criteria and are willing to participate in this research, will be consented and enrolled in this study.

Subjects will provide at least one blood sample at study enrollment and up to three optional follow-up blood samples at future visits. Relevant medical data will also be collected for each patient enrolled.

Urine samples may also be collected at the above described time-points.

Up to 500 subjects over the age of 2 worldwide who meet the study eligibility criteria are expected to be enrolled in this study. The study includes adult, pregnant, and pediatric subjects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 30, 2028
• Est. primary completion date: October 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Subject must be 2 years old or older at the time of enrollment

• Subject or Legally Authorized Representative is willing and able to sign the informed consent form (and assent form, if applicable), prior to participation in any study-related procedures.

• Subject has received at least one organ transplant prior to enrollment.

Exclusion Criteria:

• Pediatric subjects under 2 years old

• Subject received donor organ from an identical twin

Related Conditions & MeSH terms

• Allograft Rejection
• Complications
• Transplant Rejection

Locations

Country	Name	City	State
United States	Children's Hospital at Montefiore	Bronx	New York
United States	The Ohio State University	Columbus	Ohio
United States	Natera Inc.	San Carlos	California
United States	Balboa United California Institute of Renal Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Natera, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sigdel TK, Archila FA, Constantin T, Prins SA, Liberto J, Damm I, Towfighi P, Navarro S, Kirkizlar E, Demko ZP, Ryan A, Sigurjonsson S, Sarwal RD, Hseish SC, Chan-On C, Zimmermann B, Billings PR, Moshkevich S, Sarwal MM. Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR. J Clin Med. 2018 Dec 23;8(1):19. doi: 10.3390/jcm8010019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop an assay to detect allograft rejection status in transplant patients involving amplification of donor-derived cell-free DNA from donor recipient blood.	The primary outcome of the assay developed in this study would be allograft rejection high risk or low risk. This assay result will be compared to the biopsy pathology report which assesses if the transplant organ is in a state of rejection, or not. We are also measuring the donor cell free DNA, which is presumably indicating of an organ being rejected or not. Alterations in the cut off of that donor derived cell free DNA level that is allocated to high risk of rejection will be explored. Sensitivity and specificity of our assay will be calculated as needed for the purpose of validating and improving our technology in detecting donor derived cfDNA from a transplant recipient's blood. No results will be reported to patients or their treating physicians.	1-3 years

External Links

•   Optimizing Detection of Kidney Transplant Injury by Assessment of Donor-Derived Cell-Free DNA via Massively Multiplex PCR