Disorder Related to Renal Transplantation
Conditions
Keywords
living or deceased donor renal transplant recipient
Brief summary
The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.
Interventions
DRUGCampath-1H
two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Participants must be a single-organ recipient (kidney only) * Participants who are receiving their first living donor or deceased donor transplant
Exclusion criteria
* Participants who are recipients of HLA-identical living-donor renal transplants * Participants with a PRA value \> 10% within 30 days prior to the transplant * Participants who have received a multi-organ transplant * Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV * Participants who have received an investigational drug within 6 weeks of study entry * Participants who have a previous history of, or who currently have, malignancies and/or lymphoma * Participants who have received corticosteroids within three months of transplantation * Participants who are 3rd transplant recipients * Female participants who are pregnant or lactating. Fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Graft Rejection | at 1, 3, 6, 12, and 24 months |
| Participant Graft Survival | at 6, 12, and 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Malignancy | up to 24 months | — |
| Growth Post-transplant Reported by Height Z Score | up to 24 months | A z-score (aka, a standard score) indicates how many standard deviations an element is from the mean, in this case, height. A score of '0' is equal to the mean, a score less than 0 is less than the mean, and a score greater than 0 is greater than the mean. |
| Number of Participants With Hypertension | up to 24 months | — |
| Estimated Glomerular Filtration Rate (EGFR) | at 1, 6, 12 and 24 months | Measure of renal function |
| Participant Survival | at 6, 12, and 24 months | — |
| Number of Participant With Diabetes Mellitus | up to 24 months | — |
| Number of Participants With Hyperlipidemia | up to 24 months | — |
| Number of Participants With Infection | up to 24 months | Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Campath 1-H Campath-1H: two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Campath 1-H |
|---|---|
| Age, Continuous | 11.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 29 / 33 |
| serious Total, serious adverse events | 2 / 33 |
Outcome results
Primary
Incidence of Graft Rejection
Time frame: at 1, 3, 6, 12, and 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Campath 1-H | Incidence of Graft Rejection | 1 month | 0 Participants |
| Campath 1-H | Incidence of Graft Rejection | 3 months | 2 Participants |
| Campath 1-H | Incidence of Graft Rejection | 6 months | 6 Participants |
| Campath 1-H | Incidence of Graft Rejection | 12 months | 10 Participants |
| Campath 1-H | Incidence of Graft Rejection | 24 months | 11 Participants |
Primary
Participant Graft Survival
Time frame: at 6, 12, and 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Campath 1-H | Participant Graft Survival | 6 months | 32 Participants |
| Campath 1-H | Participant Graft Survival | 12 months | 32 Participants |
| Campath 1-H | Participant Graft Survival | 24 months | 32 Participants |
Secondary
Estimated Glomerular Filtration Rate (EGFR)
Measure of renal function
Time frame: at 1, 6, 12 and 24 months
Population: One participant was on dialysis at 2 years, not included in the analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Campath 1-H | Estimated Glomerular Filtration Rate (EGFR) | 1 month | 91.5 ml/min/1.73m^2 |
| Campath 1-H | Estimated Glomerular Filtration Rate (EGFR) | 6 months | 88.4 ml/min/1.73m^2 |
| Campath 1-H | Estimated Glomerular Filtration Rate (EGFR) | 12 months | 85.8 ml/min/1.73m^2 |
| Campath 1-H | Estimated Glomerular Filtration Rate (EGFR) | 24 months | 77.4 ml/min/1.73m^2 |
Secondary
Growth Post-transplant Reported by Height Z Score
A z-score (aka, a standard score) indicates how many standard deviations an element is from the mean, in this case, height. A score of '0' is equal to the mean, a score less than 0 is less than the mean, and a score greater than 0 is greater than the mean.
Time frame: up to 24 months
Population: One participant was on dialysis at 2 years, not included in the analysis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Campath 1-H | Growth Post-transplant Reported by Height Z Score | baseline | -0.99 z-score |
| Campath 1-H | Growth Post-transplant Reported by Height Z Score | 12 months | -0.41 z-score |
| Campath 1-H | Growth Post-transplant Reported by Height Z Score | 24 months | -0.35 z-score |
Secondary
Number of Participants With Hyperlipidemia
Time frame: up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Campath 1-H | Number of Participants With Hyperlipidemia | 0 Participants |
Secondary
Number of Participants With Hypertension
Time frame: up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Campath 1-H | Number of Participants With Hypertension | 27 Participants |
Secondary
Number of Participants With Infection
Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK)
Time frame: up to 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Campath 1-H | Number of Participants With Infection | BK Nephropathy | 2 Participants |
| Campath 1-H | Number of Participants With Infection | BK Viremia | 10 Participants |
| Campath 1-H | Number of Participants With Infection | BK Viruria | 12 Participants |
| Campath 1-H | Number of Participants With Infection | CMV Viremia | 4 Participants |
| Campath 1-H | Number of Participants With Infection | CMV disease | 0 Participants |
| Campath 1-H | Number of Participants With Infection | EBV Viremia | 1 Participants |
| Campath 1-H | Number of Participants With Infection | EBV disease | 0 Participants |
Secondary
Number of Participants With Malignancy
Time frame: up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Campath 1-H | Number of Participants With Malignancy | 0 Participants |
Secondary
Number of Participant With Diabetes Mellitus
Time frame: up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Campath 1-H | Number of Participant With Diabetes Mellitus | 0 Participants |
Secondary
Participant Survival
Time frame: at 6, 12, and 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Campath 1-H | Participant Survival | 6 months | 33 Participants |
| Campath 1-H | Participant Survival | 12 months | 33 Participants |
| Campath 1-H | Participant Survival | 24 months | 33 Participants |