Trial Outcomes & Findings for Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation (NCT NCT00214201)
NCT ID: NCT00214201
Last Updated: 2012-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 years
Results posted on
2012-10-03
Participant Flow
Participant milestones
| Measure |
CNI Control Post Campath 1H
Standard of Care CNI immunosuppression
|
CNI Withdrawal Post Campath 1H
Calcineurin inhibitor withdrawal
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
CNI Control Post Campath 1H
Standard of Care CNI immunosuppression
|
CNI Withdrawal Post Campath 1H
Calcineurin inhibitor withdrawal
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation
Baseline characteristics by cohort
| Measure |
CNI Control Post Campath 1H
n=20 Participants
Standard of Care CNI immunosuppression
|
CNI Withdrawal Post Campath 1H
n=20 Participants
Calcineurin inhibitor withdrawal
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
|
Total
n=40 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
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
54.1 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
55.3 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
54.7 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
CNI Control Post Campath 1H
n=20 Participants
Standard of Care CNI immunosuppression
|
CNI Withdrawal Post Campath 1H
n=20 Participants
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
|
|---|---|---|
|
Number of Participants With Biopsy Proven Rejection
|
2 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 36 months +/- 60 daysOutcome measures
| Measure |
CNI Control Post Campath 1H
n=18 Participants
Standard of Care CNI immunosuppression
|
CNI Withdrawal Post Campath 1H
n=18 Participants
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
|
|---|---|---|
|
Serum Creatinine at 36 Months (End of Study)
|
1.49 mg/dl
Standard Deviation .44
|
1.37 mg/dl
Standard Deviation .35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 months +/- 60 daysWhite Blood Cell count
Outcome measures
| Measure |
CNI Control Post Campath 1H
n=18 Participants
Standard of Care CNI immunosuppression
|
CNI Withdrawal Post Campath 1H
n=18 Participants
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
|
|---|---|---|
|
WBC
|
7.10 K/ul
Standard Deviation 1.69
|
7.68 K/ul
Standard Deviation 2.05
|
Adverse Events
CNI Control Post Campath 1H
Serious events: 11 serious events
Other events: 10 other events
Deaths: 0 deaths
CNI Withdrawal Post Campath 1H
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CNI Control Post Campath 1H
n=20 participants at risk
Standard of Care CNI immunosuppression
|
CNI Withdrawal Post Campath 1H
n=20 participants at risk
Calcineurin inhibitor withdrawal
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillaiton
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
encephalitis
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/20
|
5.0%
1/20 • Number of events 3
|
|
Immune system disorders
kidney transplant rejection
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
hydronephrosis
|
5.0%
1/20 • Number of events 1
|
15.0%
3/20 • Number of events 3
|
|
Infections and infestations
cytomegalovirus
|
10.0%
2/20 • Number of events 2
|
10.0%
2/20 • Number of events 2
|
|
Renal and urinary disorders
urinary tract infection
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
thyroid cancer
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Surgical and medical procedures
thryoidectomy
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
campylobacteremia
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Surgical and medical procedures
hernia repair
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura (ITP),
|
5.0%
1/20 • Number of events 2
|
0.00%
0/20
|
|
Cardiac disorders
myocardial infarction
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Cardiac disorders
congestive heart failure
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Camplobacter gastroenteritis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
gastritis (viral)
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
|
Surgical and medical procedures
Coronary artery bypass grafting (CABG)
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Varicella Zoster
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Cryptococcal Meningitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Surgical and medical procedures
Cholecystectomy
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Other adverse events
| Measure |
CNI Control Post Campath 1H
n=20 participants at risk
Standard of Care CNI immunosuppression
|
CNI Withdrawal Post Campath 1H
n=20 participants at risk
Calcineurin inhibitor withdrawal
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 2
|
0.00%
0/20
|
|
Renal and urinary disorders
urinary tract infection
|
5.0%
1/20 • Number of events 1
|
15.0%
3/20 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dental Abcess
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
BK Polyoma viuria
|
15.0%
3/20 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
sinusitis
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Cytomegalovirus
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract infection
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
|
Infections and infestations
Herpes Zoster
|
20.0%
4/20 • Number of events 4
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
E. Coli Urinary Tract Infection
|
10.0%
2/20 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Klebsiella pneumoniae Urinary Tract infection
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Acinetobacter Baumannii Urinary Tract infection
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Streptococcal Urinary Tract infection
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Iritis, left eye
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
CMV retinitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Epstein Barr Virus
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Skin and subcutaneous tissue disorders
Boil (groin)
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
Additional Information
Director of Clinical Trials
UW Madison
Phone: 608-263-2565
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place