The Everolimus-Transplant Exit Strategy Trial (E-TEST)

Launched by ASHTAR CHAMI · Jul 5, 2012

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • recipient of deceased or living donor kidney transplant
• • Age 18-75 years (inclusive)
• • Male or female
• • renal allograft dysfunction/deterioration evidenced by glomerular filtration rate (GFR) less than or equal to 35
• • Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy within 5 years of enrollment
• • Willing and able to provide informed consent for study participation
• Exclusion Criteria:
• • Prior solid organ transplant (other than kidney)
• • History of donor-specific antibody
• • History of biopsy-proven acute rejection within 1 year prior to enrollment
• • Proteinuria greater than or equal to 1.5 gm on spot urine protein/creatinine ratio
• • Evidence of Hepatitis C virus infection (antibody positive or polymerase chain reaction(PCR) positive)
• • Epstein Barr Virus (EBV) or cytomegalovirus (CMV) viremia at the time of enrollment
• • Subjects receiving belatacept (Nulojix)
• • Pregnant or nursing (lactating) women
• • Women of child-bearing potential (WOCBP) who are unwilling or unable to use two birth-control methods throughout participation in the study