Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

• Conditions: Kidney Transplant Recipients

• Registration Number: NCT02424227
• Lead Sponsor: CareDx

Brief 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

Detailed 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 \[eGFR\]).

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-22
• Primary Completion: 2018-08-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2018-12-17
• Study Completion: 2019-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical T cell as well as antibody mediated acute rejection	Occurring within 12 months post transplant
Sub-clinical T cell as well as antibody mediated acute rejection	Occurring within 12 months post transplant
Composite of clinical and sub-clinical T cell as well as antibody mediated acute rejection	Occurring within 12 months post transplant

Secondary Outcome Measures

Name	Time	Method
Renal allograft injury from BKV nephritis, CNI toxicity, acute pyeloenephrtiis and recurrent disease confirmed by renal histology	24 months
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	24 months

Trial Locations

Locations (14)

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Columbia University; 🇺🇸 New York, New York, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Baylor Scott and White; 🇺🇸 Temple, Texas, United States

University of Pennsylvannia; 🇺🇸 Philadelphia, Pennsylvania, United States

Baylor Research Institute; 🇺🇸 Fort Worth, Texas, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States