Kidney Transplantation
Conditions
Keywords
Kidney Transplantation, Mycophenolic Acid, Immunosuppression, Cyclosporine
Brief summary
The study will evaluate kidney graft function in maintenance renal transplant patients.
Interventions
DRUGEnteric coated mycophenolate sodium (Myfortic®)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Male or female recipients of single or double renal transplant performed since at least one year and no more that 5 years * Age \> 18 yrs * Adequate and stable renal function * Informed consent.
Exclusion criteria
* Kidney transplant combined with other organs; * Significant proteinuria * Severe ongoing infections; * Present or historical malignant neoplasia, of any type, with the exception of excised non metastatic non-melanoma skin cancer and previous malignant neoplasia cured since at least 5 years; * Relapse of the end-stage renal disease on the transplanted kidney; * Leucopenia, thrombocytopenia or severe anemia; Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months | 12 months | The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity. |
Secondary
| Measure | Time frame |
|---|---|
| Creatinine Clearance at 12 Months | 12 months |
| Serum Creatinine at 12 Months | 12 months |
| Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months | 12 months |
| Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months | 12 months |
| Chronic Rejection as Confirmed by Renal Biopsy at 12 Months | 12 months |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full Dose Myfortic® and Reduced Dose Neoral® The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME | 5 |
| Standard Dose of Myfortic® and Standard Dose of CsA-ME Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative problems | 5 | 5 |
Baseline characteristics
| Characteristic | Full Dose Myfortic® and Reduced Dose Neoral® | Standard Dose of Myfortic® and Standard Dose of CsA-ME | Total |
|---|---|---|---|
| Age Continuous | 52.4 Years STANDARD_DEVIATION 13.8 | 58.0 Years STANDARD_DEVIATION 12.5 | 55.2 Years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 5 | 4 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Renal Function, as Assessed by Glomerular Filtration Rate (GFR) at 12 Months
The 12 month change from baseline (visit 2) in the glomerular filtration rate using the abbreviated Modification of Diet in Renal Disease (MDRD) formula to calculate GFR using the participant's serum creatinine, age, gender and ethnicity.
Time frame: 12 months
Population: Study was terminated without analysis (small sample size).
Secondary
Biopsy Proven Acute Rejections and Clinically Confirmed Acute Rejection at 12 Months
Time frame: 12 months
Secondary
Chronic Rejection as Confirmed by Renal Biopsy at 12 Months
Time frame: 12 months
Secondary
Creatinine Clearance at 12 Months
Time frame: 12 months
Secondary
Reciprocal Slope of Serum Creatinine (mg/dL) or Micromole/l at 12 Months
Time frame: 12 months
Secondary
Serum Creatinine at 12 Months
Time frame: 12 months