Trial Outcomes & Findings for CamTac Trial:Campath-Tacrolimus vs IL2R MoAb/Tacrolimus/MMF in Renal Transplantation (NCT NCT00246129)

NCT ID: NCT00246129

Last Updated: 2021-09-29

Results Overview

One year survival with a functioning graft, defined as transplant recipient remaining alive and dialysis-independent. the functioning graft is a graft still functioning at the time of analysis. Graft function was estimated using the Modification of Diet in Renal Disease four-variable formula and comparison of graft function between arms undertaken with Student'st test.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 123 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2021-09-29

Participant Flow

Participant milestones

Measure	Campath-Tacrolimus Campath (1x30mg) induction with 7-day short-course steroids followed by tacrolimus monotherapy (dose adjusted to target trough level 9-11ng/ml)	Daclizumab-Tacrolimus-Mycophenolate Daclizumab 2mg/kg x2 days 0+14) induction with 7-day short-course steroids followed by Tacrolimus (adjusted to target trough 9-11ng/ml) and Mycophenolate mofetil therapy (750mg bd)
Overall Study STARTED	82	41
Overall Study COMPLETED	75	39
Overall Study NOT COMPLETED	7	2

Reasons for withdrawal

Measure	Campath-Tacrolimus Campath (1x30mg) induction with 7-day short-course steroids followed by tacrolimus monotherapy (dose adjusted to target trough level 9-11ng/ml)	Daclizumab-Tacrolimus-Mycophenolate Daclizumab 2mg/kg x2 days 0+14) induction with 7-day short-course steroids followed by Tacrolimus (adjusted to target trough 9-11ng/ml) and Mycophenolate mofetil therapy (750mg bd)
Overall Study Lost to Follow-up	1	0
Overall Study Death	2	1
Overall Study suffered primary non-function	1	0
Overall Study grafts failed	3	1

Baseline Characteristics

CamTac Trial:Campath-Tacrolimus vs IL2R MoAb/Tacrolimus/MMF in Renal Transplantation

Baseline characteristics by cohort

Measure	Campath-Tacrolimus n=82 Participants Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 Participants Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy	Total n=123 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	77 Participants n=5 Participants	39 Participants n=7 Participants	116 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	47.3 years STANDARD_DEVIATION 13.4 • n=5 Participants	47.0 years STANDARD_DEVIATION 10.6 • n=7 Participants	47.2 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	14 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	27 Participants n=7 Participants	81 Participants n=5 Participants
Region of Enrollment United Kingdom	82 participants n=5 Participants	41 participants n=7 Participants	123 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

One year survival with a functioning graft, defined as transplant recipient remaining alive and dialysis-independent. the functioning graft is a graft still functioning at the time of analysis.

Graft function was estimated using the Modification of Diet in Renal Disease four-variable formula and comparison of graft function between arms undertaken with Student'st test.

Outcome measures

Measure	Campath-Tacrolimus n=82 Participants Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 Participants Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
One Year Survival With a Functioning Graft	97.6 Percent of patients Interval 90.6 to 99.4	95.1 Percent of patients Interval 81.9 to 98.8

SECONDARY outcome

Timeframe: 1 year

Biopsy-proven rejection episodes classified using Banff criteria

Outcome measures

Measure	Campath-Tacrolimus n=82 Participants Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 Participants Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Occurrence of Rejection Episodes	91.2 Percentage of patients Interval 82.4 to 95.7	82.3 Percentage of patients Interval 66.4 to 91.1

SECONDARY outcome

Timeframe: 1 year

Occurence of infection of sufficient severity to produce positive cultures or Nucleic-acid test results from blood, urine, or other body fluids

Outcome measures

Measure	Campath-Tacrolimus n=82 Participants Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 Participants Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Occurrence of Significant Episodes of Infection	73 # of occurrences per 100 patient years	76 # of occurrences per 100 patient years

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Campath-Tacrolimus n=82 Participants Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 Participants Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Initial Length of Stay in Hospital	11.7 Days Standard Deviation 6.4	12.1 Days Standard Deviation 7.6

SECONDARY outcome

Timeframe: 3 years

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Biopsy proven Calcineurin Inhibitor (CNI) toxicity free survival

Outcome measures

Measure	Campath-Tacrolimus n=82 Participants Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 Participants Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Early Development of Scarring in the Grafts	96 Percentage of participants with no scar	90 Percentage of participants with no scar

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Campath-Tacrolimus n=82 Participants Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 Participants Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Graft Function: Level of Creatinine	127.3 mmol/L Standard Deviation 36.2	147.0 mmol/L Standard Deviation 69.1

SECONDARY outcome

Timeframe: 2 years

Cumulative patient survival

Outcome measures

Measure	Campath-Tacrolimus n=82 Participants Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 Participants Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Patient Survival Censored for Death With Function	98 Percentage of transplant recipients	98 Percentage of transplant recipients

SECONDARY outcome

Timeframe: 2 years

Graft survival (defined as grafts maintaining dialysis independence)

Outcome measures

Measure	Campath-Tacrolimus n=82 Participants Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 Participants Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Graft Survival Censored for Death With Function	91 Percentage of grafts	95 Percentage of grafts

Adverse Events

Campath-Tacrolimus

Serious events: 5 serious events

Other events: 59 other events

Deaths: 2 deaths

Daclizumab-Tacrolimus-Mycophenolate

Serious events: 5 serious events

Other events: 30 other events

Deaths: 1 deaths

Serious adverse events

Measure	Campath-Tacrolimus n=82 participants at risk Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 participants at risk Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Blood and lymphatic system disorders Immune thrombocytopenic purpura	1.2% 1/82 • Number of events 1 • 1 year	0.00% 0/41 • 1 year
Metabolism and nutrition disorders New-onset diabetes after transplantation	4.9% 4/82 • Number of events 4 • 1 year	12.2% 5/41 • Number of events 5 • 1 year

Other adverse events

Measure	Campath-Tacrolimus n=82 participants at risk Campath induction with 7-day short-course steroids followed by tacrolimus monotherapy	Daclizumab-Tacrolimus-Mycophenolate n=41 participants at risk Daclizumab induction with 7-day short-course steroids followed by Tacrolimus and Mycophenolate mofetil therapy
Infections and infestations Urinary tract infection	37.8% 31/82 • Number of events 31 • 1 year	22.0% 9/41 • Number of events 9 • 1 year
Infections and infestations Bacteremia	18.3% 15/82 • Number of events 15 • 1 year	22.0% 9/41 • Number of events 9 • 1 year
Infections and infestations Wound infection	7.3% 6/82 • Number of events 6 • 1 year	14.6% 6/41 • Number of events 6 • 1 year
Infections and infestations Cytomegalovirus infection	1.2% 1/82 • Number of events 1 • 1 year	9.8% 4/41 • Number of events 4 • 1 year
Infections and infestations Other infection	7.3% 6/82 • Number of events 6 • 1 year	4.9% 2/41 • Number of events 2 • 1 year

Additional Information

Dr Adam McLean

imperial College Kidney & Transplant Centre

Phone: +44 (0) 208 383 5164

Email: adam.mclean@imperial.nhs.uk

Results disclosure agreements

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