Overview

This trial is active, not recruiting.

Condition kidney transplant recipients
Sponsor CareDx
Start date April 2015
End date December 2017
Trial size 401 participants
Trial identifier NCT02424227, SN-C-00006

Summary

This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Adult living and deceased donor kidney transplant recipients will be eligible to participate in this study.

Primary Outcomes

Measure
Clinical T cell as well as antibody mediated acute rejection
time frame: Occurring within 12 months post transplant
Sub-clinical T cell as well as antibody mediated acute rejection
time frame: Occurring within 12 months post transplant
Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection
time frame: Occurring within 12 months post transplant

Secondary Outcomes

Measure
eGFR (estimated Glomerular Filtration Rate [mL/min]): will be derived from serum creatinine level, corrected for variables, using the CKD-RPI (Chronic Kidney Disease Epidemiology Collaboration) equation
time frame: 24 months
Renal allograft injury from BKV nephritis, CNI toxicity, acute pyeloenephrtiis and recurrent disease confirmed by renal histology
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria 1. Adult recipients (Age > 18 years ) 2. Both genders and all racial and ethnic groups 3. Kidney transplant alone 4. Both living and deceased donor transplants 5. Primary and re-transplants. A total of 30 re-transplant recipients across all study sites will be eligible for enrollment. CareDx will notify all centers when this subset of enrollment has been met. Thereafter, all enrolled patients should be primary transplant recipients. 6. Ability to come for follow-up and undergo biopsy (Performed in accordance to SOC) 7. Ability to give written informed consent prior to study enrollment Patients can be enrolled at any time; before or after transplantation and/or at time of outpatient or inpatient visits for workup of medical problems; e.g. at the time of a renal biopsy (regardless of elapsed time since post transplant) as specified in this study protocol. Exclusion Criteria 1. Pediatric recipients (Age < 18 years) 2. Pregnant women 3. Patients undergoing multi-organ transplants (e.g. kidney with pancreas or liver) 4. Patients receiving donor organ from an identical twin

Additional Information

Official title Circulating Donor-Derived Cell-free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients
Description This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant periodically and also after the treatment of acute rejection up to 8 weeks post treatment. The blood samples and all relevant clinical data will be provided to CareDx scientists for laboratory assay of dd-cfDNA levels and correlation of dd-cfDNA levels with the clinical features of the subjects. The primary objective of the study is to correlate circulating dd-cfDNA to clinical and sub-clinical acute rejection in renal allograft recipients. The secondary objective of the study is to correlate circulating dd-cfDNA to renal function, both serum creatinine and estimated glomerular filtration rate [eGFR]).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by CareDx.