Renal Transplant Rejection
Conditions
Keywords
Kidney Transplantation, Immunosuppression
Brief summary
This study aims to compare outcomes in renal transplant recipients in the hispanic population based on their immunosuppressant regimens.
Detailed description
This study aims to include Hispanics who have undergone a renal transplant to determine the specific outcome after renal transplantation, assuming that ethnic groups require different immunosuppressant regimens. Trough levels in transplant recipients determine the dosing requirements for Tacrolimus and Cyclosproine. It has been recently found, however, that testing cyclosporine levels in the blood 2 hours after taking cyclosporine is more effective in dosing cyclosprine for renal transplant patients than trough levels. The specific study aims include comparing the cyclosporine monitoring in patients with trough and C2 levels, and adjusting immunosuppression based on C2 levels.
Interventions
DRUGPrograf
Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID
DRUGNeoral
Cyclosporine (Neoral) starting dose 3mg/kg PO BID
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Cadaveric or Living Donors * 18 years old or greater * Primary renal transplants * Hispanic ethnicity
Exclusion criteria
* Prior renal transplant * Multi-organ transplant * Recipient with history of Diabetes Mellitus * PRA \> 20% * Cold Ischemia Time \> 24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rejection | 6 months post-transplant |
Secondary
| Measure | Time frame |
|---|---|
| Renal Function | 6 months post-transplant |
| Post-transplant Diabetes Mellitus | 6 months post-transplant |
| Lipid Levels | 6 months post-transplant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neoral Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants
Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID | 8 |
| Prograf Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.
Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Neoral | Prograf | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Continuous | 29.875 years | 42.14 years | 35.6 years |
| Region of Enrollment United States | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Rejection
Time frame: 6 months post-transplant
Population: Data cannot be located for analysis.
Secondary
Lipid Levels
Time frame: 6 months post-transplant
Population: Data cannot be located for analysis.
Secondary
Post-transplant Diabetes Mellitus
Time frame: 6 months post-transplant
Population: Data cannot be located for analysis.
Secondary
Renal Function
Time frame: 6 months post-transplant
Population: Data cannot be located for analysis.