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

Phase 3

Terminated

• Conditions: Kidney Failure, Chronic
• Interventions: Drug: Everolimus

• Registration Number: NCT01636466
• Lead Sponsor: Ashtar Chami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-10
• Study Start: 2013-06
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-05-26
• Results First Submitted QC: 2015-05-26
• Results First Posted: 2015-06-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-09
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus conversion	Everolimus	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.

Primary Outcome Measures

Name	Time	Method
Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)	36 months	Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI \>5000 defined as positive

Secondary Outcome Measures

Name	Time	Method
Incidence of Return to Dialysis Dependence	36 months

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States