Graft vs Host Disease, Kidney Failure
Conditions
Keywords
Kidney, Transplant
Brief summary
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.
Interventions
DRUGTacrolimus
DRUGSirolimus
DRUGprednisone
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* End-stage renal disease, with patients scheduled to receive a kidney transplant. * Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs; * Signed informed consent.
Exclusion criteria
* Evidence of active systemic or localized major infection at the time of initial study drug administration; * Multiple organ transplants; * Any pathology or medical condition that can interfere with this protocol study proposal. Other exclusion applies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. | 12 months | Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Creatinine Clearance Rate | 12 months | Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function. |
Countries
Brazil
Participant flow
Recruitment details
Subjects were recruited in Brazil from August 2005 to September 2006.
Pre-assignment details
After renal transplantation subjects were immediately randomized into day 1.
Participants by arm
| Arm | Count |
|---|---|
| Sirolimus + Tacrolimus | 24 |
| Sirolimus + Prednisone | 23 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 4 |
| Overall Study | Lack of Efficacy | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Sirolimus + Tacrolimus | Sirolimus + Prednisone | Total |
|---|---|---|---|
| Age, Continuous | 35.3 years STANDARD_DEVIATION 11.3 | 34.7 years STANDARD_DEVIATION 12.2 | 35.0 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 20 Participants |
| Sex: Female, Male Male | 16 Participants | 11 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 24 | 22 / 23 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 |
Outcome results
Primary
Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).
Time frame: 12 months
Population: The population that was used for this analysis was the transplantation recipient population, which included all randomized patients.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sirolimus + Tacrolimus | Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. | Subjects with Acute Rejection | 3 participants |
| Sirolimus + Tacrolimus | Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. | Subjects without Acute Rejection | 21 participants |
| Sirolimus + Prednisone | Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. | Subjects with Acute Rejection | 3 participants |
| Sirolimus + Prednisone | Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up. | Subjects without Acute Rejection | 20 participants |
p-value: 1Fisher Exact
Secondary
Creatinine Clearance Rate
Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Time frame: 12 months
Population: The population that was used for this analysis was patients who completed 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sirolimus + Tacrolimus | Creatinine Clearance Rate | 60 ml/min | Standard Deviation 11.5 |
| Sirolimus + Prednisone | Creatinine Clearance Rate | 63.4 ml/min | Standard Deviation 10.5 |
p-value: 0.361Student's t-test