Primary Renal Transplant
Conditions
Brief summary
The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.
Interventions
DRUGCalcineurin inhibitor withdrawal
stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.
Exclusion criteria
* Recipients of HLA-identical living-donor renal transplants; * PRA value \>20% within 30 days of transplant; * GFR \<40ml/min; * multi-organ transplant;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Biopsy Proven Rejection | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Serum Creatinine at 36 Months (End of Study) | 36 months +/- 60 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| WBC | 36 months +/- 60 days | White Blood Cell count |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CNI Control Post Campath 1H Standard of Care CNI immunosuppression | 20 |
| CNI Withdrawal Post Campath 1H Calcineurin inhibitor withdrawal
Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | CNI Control Post Campath 1H | CNI Withdrawal Post Campath 1H | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 17 Participants | 33 Participants |
| Age Continuous | 54.1 years STANDARD_DEVIATION 9.2 | 55.3 years STANDARD_DEVIATION 9.4 | 54.7 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 20 | 11 / 20 |
| serious Total, serious adverse events | 11 / 20 | 8 / 20 |
Outcome results
Primary
Number of Participants With Biopsy Proven Rejection
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CNI Control Post Campath 1H | Number of Participants With Biopsy Proven Rejection | 2 participants |
| CNI Withdrawal Post Campath 1H | Number of Participants With Biopsy Proven Rejection | 7 participants |
Secondary
Serum Creatinine at 36 Months (End of Study)
Time frame: 36 months +/- 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNI Control Post Campath 1H | Serum Creatinine at 36 Months (End of Study) | 1.49 mg/dl | Standard Deviation 0.44 |
| CNI Withdrawal Post Campath 1H | Serum Creatinine at 36 Months (End of Study) | 1.37 mg/dl | Standard Deviation 0.35 |
Other Pre-specified
WBC
White Blood Cell count
Time frame: 36 months +/- 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CNI Control Post Campath 1H | WBC | 7.10 K/ul | Standard Deviation 1.69 |
| CNI Withdrawal Post Campath 1H | WBC | 7.68 K/ul | Standard Deviation 2.05 |