Trial Outcomes & Findings for Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation (NCT NCT01346397)
NCT ID: NCT01346397
Last Updated: 2016-11-29
Results Overview
in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
Recruitment status
COMPLETED
Target enrollment
170 participants
Primary outcome timeframe
5 years
Results posted on
2016-11-29
Participant Flow
Participant milestones
| Measure |
Cyclosporine Group
cyclosporine group - after Campath induction cyclosporine will be administered
|
Tacrolimus Group
tacrolimus group - after Campath induction tacrolimus will be administered
|
|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
|
Overall Study
COMPLETED
|
85
|
85
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation
Baseline characteristics by cohort
| Measure |
Cyclosporine Group
n=85 Participants
cyclosporine group - after alemtuzumab induction cyclosporine was administered
|
Tacrolimus Group
n=85 Participants
tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19 years
STANDARD_DEVIATION 14 • n=5 Participants
|
21 years
STANDARD_DEVIATION 15 • n=7 Participants
|
20 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Gender
Female
|
33 participants
n=5 Participants
|
35 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Gender
Male
|
52 participants
n=5 Participants
|
40 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Deceased donor kidney transplant recipients
|
28 participants
n=5 Participants
|
21 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsin cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%
Outcome measures
| Measure |
Cyclosporine Group
n=85 Participants
cyclosporine group - after alemtuzumab induction cyclosporine was administered
|
Tacrolimus Group
n=85 Participants
tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered
|
|---|---|---|
|
Patient Survival
|
96.4 percentage of participants
Interval 94.0 to 98.8
|
96.3 percentage of participants
Interval 92.9 to 99.7
|
PRIMARY outcome
Timeframe: 5 yearsin cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%
Outcome measures
| Measure |
Cyclosporine Group
n=85 Participants
cyclosporine group - after alemtuzumab induction cyclosporine was administered
|
Tacrolimus Group
n=85 Participants
tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered
|
|---|---|---|
|
Graft Survival
|
84.6 percentage of participants
Interval 78.7 to 90.5
|
86.2 percentage of participants
Interval 82.6 to 93.5
|
Adverse Events
Cyclosporine Group
Serious events: 13 serious events
Other events: 40 other events
Deaths: 0 deaths
Tacrolimus Group
Serious events: 12 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cyclosporine Group
n=85 participants at risk
cyclosporine group - after alemtuzumab induction cyclosporine was administered
|
Tacrolimus Group
n=85 participants at risk
tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered
|
|---|---|---|
|
Renal and urinary disorders
kidney graft loss
|
10.6%
9/85 • Number of events 9
|
10.6%
9/85 • Number of events 9
|
|
Cardiac disorders
patient death
|
4.7%
4/85 • Number of events 4
|
3.5%
3/85 • Number of events 3
|
Other adverse events
| Measure |
Cyclosporine Group
n=85 participants at risk
cyclosporine group - after alemtuzumab induction cyclosporine was administered
|
Tacrolimus Group
n=85 participants at risk
tacrolimus group - after alemtuzumab induction tacrolimus was administered
cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered
|
|---|---|---|
|
Immune system disorders
clinical acute rejection
|
35.3%
30/85 • Number of events 30
|
8.2%
7/85 • Number of events 7
|
|
Renal and urinary disorders
all rejection rate, including subclinical rejections.
|
47.1%
40/85 • Number of events 40
|
14.1%
12/85 • Number of events 12
|
Additional Information
Dr Michael Kaabak
Boris Petrovsky research cener od surgery
Phone: +74992481344
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place