Trial Outcomes & Findings for Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation (NCT NCT00807144)

NCT ID: NCT00807144

Last Updated: 2021-08-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 102 participants
• Primary outcome timeframe: One year post kidney transplantation
• Results posted on: 2021-08-27

Participant Flow

Participant milestones

Measure	Extended Release Tacrolimus Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml	Standard Release Tacrolimus Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
Overall Study STARTED	52	50
Overall Study COMPLETED	52	49
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Extended Release Tacrolimus Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml	Standard Release Tacrolimus Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation

Baseline characteristics by cohort

Measure	Extended Release Tacrolimus n=52 Participants Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml	Standard Release Tacrolimus n=50 Participants Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml	Total n=102 Participants Total of all reporting groups
Age, Continuous	53.1 years STANDARD_DEVIATION 15.8 • n=5 Participants	51.5 years STANDARD_DEVIATION 14.04 • n=7 Participants	52.3 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	37 Participants n=7 Participants	76 Participants n=5 Participants
Race/Ethnicity, Customized Afro Carribean	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	36 Participants n=5 Participants	30 Participants n=7 Participants	66 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United Kingdom	52 participants n=5 Participants	50 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: One year post kidney transplantation

Outcome measures

Measure	Extended Release Tacrolimus n=52 Participants Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml	Standard Release Tacrolimus n=50 Participants Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
Patient Survival With a Functioning Graft	92.3 percent of participants	96 percent of participants

SECONDARY outcome

Timeframe: One and two years post kidney transplantation

Outcome measures

Measure	Extended Release Tacrolimus n=52 Participants Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml	Standard Release Tacrolimus n=50 Participants Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
Rejection-free Patient Survival With a Functioning Graft year 1	86 percent of participants	84 percent of participants
Rejection-free Patient Survival With a Functioning Graft year 2	83.4 percent of participants	80.1 percent of participants

SECONDARY outcome

Timeframe: 3,6,& 12 months post kidney transplant

Population: Data not collected

Outcome measures

Outcome data not reported

Adverse Events

Extended Release Tacrolimus

Serious events: 0 serious events

Other events: 8 other events

Deaths: 4 deaths

Standard Release Tacrolimus

Serious events: 1 serious events

Other events: 9 other events

Deaths: 2 deaths

Serious adverse events

Measure	Extended Release Tacrolimus n=52 participants at risk Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml	Standard Release Tacrolimus n=50 participants at risk Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
Hepatobiliary disorders Liver failure	0.00% 0/52 • 2 years	2.0% 1/50 • Number of events 1 • 2 years

Other adverse events

Measure	Extended Release Tacrolimus n=52 participants at risk Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml	Standard Release Tacrolimus n=50 participants at risk Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
General disorders Any rejection symptom	15.4% 8/52 • Number of events 8 • 2 years	18.0% 9/50 • Number of events 9 • 2 years

Additional Information

Adam McLean

Imperial College Healthcare NHS Trust

Phone: +44 020 8383 5164

Email: adammclean@nhs.net

Results disclosure agreements

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