Trial Outcomes & Findings for Comparing Everolimus and Sirolimus in Renal Transplant Recipients (NCT NCT01976390)

Results Overview

The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at 1 year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

1 Year

Results posted on

2022-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	Zortress (Everolimus) Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral. Everolimus: 0.75mg twice a day, Orally, starting on day of transplant	Rapamune (Sirolimus) Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d. Sirolimus: 5mg, Orally, starting on day of transplant; decreasing to 3mg
Overall Study STARTED	41	19
Overall Study COMPLETED	41	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zortress (Everolimus) n=41 Participants Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral. Everolimus: 0.75mg twice a day, Orally, starting on day of transplant	Rapamune (Sirolimus) n=19 Participants Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d. Sirolimus: 5mg, Orally, starting on day of transplant; decreasing to 3mg	Total n=60 Participants Total of all reporting groups
Age, Continuous	49.7 years STANDARD_DEVIATION 11.9 • n=41 Participants	49.5 years STANDARD_DEVIATION 12.2 • n=19 Participants	49.6 years STANDARD_DEVIATION 11.9 • n=60 Participants
Sex: Female, Male Female	17 Participants n=41 Participants	5 Participants n=19 Participants	22 Participants n=60 Participants
Sex: Female, Male Male	24 Participants n=41 Participants	14 Participants n=19 Participants	38 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 1 Year

The primary objective of this pilot study will be to determine equivalency of Zortress® as compared to Rapamune® when used in our de novo immunosuppression regimen following renal transplantation. The primary endpoint will be a composite endpoint of graft survival (non-death censored) and biopsy proven acute rejection at 1 year. The primary outcome of immunosuppressive protection would be studied in our Thymoglobulin and rapid steroid discontinuation protocol, with "half-dose" Neoral as described above.

Outcome measures

Outcome measures
Measure	Zortress (Everolimus) n=41 Participants Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral. Everolimus: 0.75mg twice a day, Orally, starting on day of transplant	Rapamune (Sirolimus) n=19 Participants Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d. Sirolimus: 5mg, Orally, starting on day of transplant; decreasing to 3mg
Number of Participants With Composite Endpoint of Graft Survival (Non-death Censored) and Biopsy Proven Acute Rejection at 1 Year graft survival (non-death censored) at 1 year	40 Participants	19 Participants
Number of Participants With Composite Endpoint of Graft Survival (Non-death Censored) and Biopsy Proven Acute Rejection at 1 Year biopsy proven acute rejection at 1 year	38 Participants	19 Participants

Adverse Events

Zortress (Everolimus)

Serious events: 35 serious events

Other events: 0 other events

Deaths: 0 deaths

Rapamune (Sirolimus)

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zortress (Everolimus) n=41 participants at risk Zortress will be started on day of transplant and initially dosed at 0.75 mg twice a day (12 hours apart) dosed simultaneously with Neoral. Everolimus: 0.75mg twice a day, Orally, starting on day of transplant	Rapamune (Sirolimus) n=19 participants at risk Rapamune will be dosed on day of transplant at 5 mg/d, decreasing to 3 mg/d. Sirolimus: 5mg, Orally, starting on day of transplant; decreasing to 3mg
General disorders Serious Adverse Effects	85.4% 35/41 • 1 year Electronic medical records	89.5% 17/19 • 1 year Electronic medical records

Other adverse events

Adverse event data not reported

Additional Information

Director of Research Operations

Division of Transplant Surgery OSUMC

Phone: 614-293-8021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place