Trial Outcomes & Findings for The Everolimus-Transplant Exit Strategy Trial (E-TEST) (NCT NCT01636466)

NCT ID: NCT01636466

Last Updated: 2018-02-05

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2018-02-05

Participant Flow

Participant milestones

Measure	Everolimus Conversion Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.	Control Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Everolimus Conversion n=1 Participants Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.	Control Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	—	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: 36 months

Population: Single subject enrolled was terminated early. Data analysis was not performed as the Month 36 visit did not occur.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: Single subject enrolled was terminated early. Data analysis was not performed as the Month 36 visit did not occur.

Outcome measures

Outcome data not reported

Adverse Events

Everolimus Conversion

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Everolimus Conversion n=1 participants at risk Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.	Control Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
Renal and urinary disorders Pyelonephritis	100.0% 1/1 • Number of events 1	— 0/0

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ashtar Chami

Emory University

Phone: 404-712-7735

Email: ashtar.chami@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place