Renal Transplant
Conditions
Keywords
prevent kidney rejection
Brief summary
The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.
Detailed description
Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus. Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).
Interventions
DRUGCampath-1H
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* primary renal transplant (not HLA identical) * ages 18-60 years
Exclusion criteria
* recipient panel reactive antibody level \>10% * recipient of a DCD kidney * no prior organ transplant * no multi-organ transplant recipient * no subject who is currently receiving systemic corticosteroids * no pregnant or lactating subjects * no history of Hepatitis B, C or HIV positivity * no recipient of a kidney with cold ischemia time \>36 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Allograft Rejection | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment) | 3 years | — |
| Patient Survival | 3 years | — |
| Incidence of Post-transplant Infection | 3 years | Event of post-transplant infection (more than one event might have been counted per participant) |
| Incidence of Malignancies | 3 years | Number of Participants Experiencing Malignancies |
| Kidney Allograft Survival | 3 years | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Campath 1H induction w/ Sirolimus immunosuppression | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants |
| Age Continuous | 41 years |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 28 / 28 |
| serious Total, serious adverse events | 19 / 28 |
Outcome results
Primary
Incidence of Allograft Rejection
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Incidence of Allograft Rejection | 13 participants |
Secondary
Incidence of Malignancies
Number of Participants Experiencing Malignancies
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Incidence of Malignancies | 2 participants |
Secondary
Incidence of Post-transplant Infection
Event of post-transplant infection (more than one event might have been counted per participant)
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Incidence of Post-transplant Infection | 28 event of infection |
Secondary
Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment) | 6 participants |
Secondary
Kidney Allograft Survival
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Kidney Allograft Survival | 27 participants |
Secondary
Patient Survival
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 | Patient Survival | 28 participants |