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Clinical Use of the 3-Gene Signature: Use of the Urinary Cell 3-Gene Signature to Initiate Preemptive Low Dose Prednisone Therapy and Prevent Acute Rejection and Use of the Urinary 3-gene Signature as a Surrogate for Biopsy Diagnosis of Acute Rejection

Clinical Trial Details

The objectives of our study are: (1) to use our validated urinary cell 3-gene signature to prevent the development of clinical rejection; and (2) to use our validated urinary biomarkers that noninvasively diagnose clinical rejection and avoid performing a diagnostic kidney transplant biopsy. In the translational study designed to prevent the development of a future rejection, we are proposing a low-dose, oral prednisone regimen, to be initiated based on the score of our biomarker signature. We anticipate 75 patients to be treated with the low-dose, oral prednisone regimen and will use the score of our biomarker signature to initiate our standard anti-rejection therapy and avoid performing a diagnostic biopsy.

Key eligibility:

  • Kidney transplant recipient and within 30 days of kidney transplant surgery
  • Age 18-75 years
  • Ability to provide informed consent
  • Not enrolled in other interventional studies
  • Detailed eligibility provided when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Emmanuel Edusei
(212) 746-6112
eme2005@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1312014627

Status

Open to Enrollment

Age Group

Adult

Sponsor