NCT02424227

Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation

Circulating Donor-Derived Cell-free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 401 (actual)
• Sponsor: CareDx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[eGFR\]).

Conditions

• Kidney Transplant Recipients

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-08-30
• Completion: 2019-01-31
• First posted: 2015-04-22
• Last updated: 2018-12-17

Locations

14 sites across 1 country: United States