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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Everolimus conversion

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.

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Everolimus will initially be dosed at 0.75 mg tablet taken orally twice a day. The dose will be adjusted to maintain serum trough concentrations of 5-8 ng/ml.

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Everolimus

Everolimus will initially be dosed at 0.75 mg tablet taken orally twice a day. The dose will be adjusted to maintain serum trough concentrations of 5-8 ng/ml.

Intervention Type DRUG

Other Intervention Names

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Zortress

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No