Trial Outcomes & Findings for Sirolimus Conversions in African-American Renal Transplant Recipients (NCT NCT01005706)

NCT ID: NCT01005706

Last Updated: 2016-03-11

Results Overview

Number of Participants with Kidney Rejections

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2016-03-11

Participant Flow

Participant milestones

Measure	Tacrolimus Withdrawal Arm At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.	Tacrolimus Minimization Arm Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml. At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Overall Study STARTED	23	17
Overall Study COMPLETED	23	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sirolimus Conversions in African-American Renal Transplant Recipients

Baseline characteristics by cohort

Measure	Tacrolimus Withdrawal Arm n=23 Participants At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.	Tacrolimus Minimization Arm n=17 Participants Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml. At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.	Total n=40 Participants Total of all reporting groups
Age, Continuous	51 years STANDARD_DEVIATION 14 • n=5 Participants	54 years STANDARD_DEVIATION 11 • n=7 Participants	52 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	8 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Number of Participants with Kidney Rejections

Outcome measures

Measure	Tacrolimus Withdrawal Arm n=23 Participants At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.	Tacrolimus Minimization Arm n=17 Participants Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml. At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection	4 participants	1 participants

Adverse Events

Tacrolimus Withdrawal Arm

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Tacrolimus Minimization Arm

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tacrolimus Withdrawal Arm n=23 participants at risk At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.	Tacrolimus Minimization Arm n=17 participants at risk Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml. At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
General disorders Death	4.3% 1/23	0.00% 0/17

Other adverse events

Measure	Tacrolimus Withdrawal Arm n=23 participants at risk At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml. Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.	Tacrolimus Minimization Arm n=17 participants at risk Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml. At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Infections and infestations Infection	34.8% 8/23	64.7% 11/17
Immune system disorders CMV	4.3% 1/23	11.8% 2/17
Immune system disorders BK Viremia	8.7% 2/23	17.6% 3/17

Additional Information

Charles F. Bratton, MD

Medical University of South Carolina

Phone: 843-792-4003

Email: brattocf@musc.edu

Results disclosure agreements

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