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

Ashtar Chami

Status and phase: Terminated; Phase 3

Conditions: Kidney Failure, Chronic

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01636466

IRB00059278

CRAD001AUS191T (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®) in preventing antibody formation in patients with chronic failing kidney transplants. Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the prevention of rejection in kidney transplant.

The primary objective for the study is to determine whether conversion of patients with chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent allosensitization. The secondary objective will be to determine whether conversion of patients with chronic renal graft failure to everolimus (elimination of calcineurin inhibitor) will delay the onset of dialysis.

Enrollment: 1 patient

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Everolimus conversion

Experimental group

Description:

Subjects who have previously undergone a kidney transplant and are in late stage renal allograft failure will be randomized to take everolimus 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects will be weaned off of all other immunosuppression medicines when dialysis starts.

Treatment:

Drug: Everolimus

Control

No Intervention group

Description:

Subjects who have previously undergone a kidney transplant and are in late stage renal allograft failure will be randomized to continue on current immunosuppressive regimen. Subjects will be weaned off of all immunosuppression medicines when dialysis starts.