Trial Outcomes & Findings for Study Evaluating Conversion From Tacrolimus to Sirolimus in Stable Kidney Transplant Recipients Receiving Myfortic (NCT NCT00713284)

NCT ID: NCT00713284

Last Updated: 2020-10-27

Results Overview

Renal allograft function will be assessed based on serum creatinine

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 29 participants
• Primary outcome timeframe: six months
• Results posted on: 2020-10-27

Participant Flow

Participant milestones

Measure	Sirolimus Conversion All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus.
Overall Study STARTED	29
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating Conversion From Tacrolimus to Sirolimus in Stable Kidney Transplant Recipients Receiving Myfortic

Baseline characteristics by cohort

Measure	Sirolimus Conversion n=13 Participants All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	54.15 years STANDARD_DEVIATION 10.85 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Transplant Type Deceased donor	6 Participants n=5 Participants
Transplant Type Living Unrelated donor	4 Participants n=5 Participants
Transplant Type Living Related donor	3 Participants n=5 Participants
Expanded Criteria Donor Expanded Criteria Donor	2 Participants n=5 Participants
Expanded Criteria Donor Not Expanded Criteria Donor	11 Participants n=5 Participants
Time to Conversion	147.85 days STANDARD_DEVIATION 36 • n=5 Participants

PRIMARY outcome

Timeframe: six months

Population: One patient experienced an adverse drug reaction and was withdrawn from study treatment one month after conversion

Renal allograft function will be assessed based on serum creatinine

Outcome measures

Measure	Sirolimus Conversion n=13 Participants All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus.
Renal Allograft Function Creatinine (Baseline)	1.34 mg/dL Standard Deviation 0.24
Renal Allograft Function Creatinine (6 months)	1.38 mg/dL Standard Deviation 0.31

Adverse Events

Sirolimus Conversion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sirolimus Conversion n=13 participants at risk All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus.
Renal and urinary disorders Rise in creatinine	7.7% 1/13 • Number of events 1
Skin and subcutaneous tissue disorders Edema	7.7% 1/13 • Number of events 1

Additional Information

Dr. V. Ram Peddi

California Pacific Medical Center

Phone: 415-600-1000

Email: peddir@sutterhealth.org

Results disclosure agreements

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