Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients

To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.

Time frame: Month 12

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

The GFR was calculated according to the Modification of Diet in Renal Disease Study Group (MDRD) method, the Cockcroft-Gault method, and the Nankivell formula. cGFR was calculated from blood samples collected at predefined time points.

Time frame: Months 12, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Health-related QoL was assessed using the EQ-5D questionnaire. The EQ-5D self-report questionnaire consists of the EQ-5D descriptive system that measures health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity (no problems/moderate problems/severe problems) within a particular EQ-5D dimension. Scores are transformed to a range of 0-1, in which higher scores reflect better health status.

Time frame: Before randomization, Months 12, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Blood lipid levels of patients in both groups for Apolipoprotein (Apo) A1 and B.

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Blood lipid levels of patients in both groups: HDL-C, LDL-C,Total cholesterol, and triglycerides.

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Progression of renal function measured by mean mGFR at 36 months after renal TX. The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.

Time frame: Month 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR). Patients who did not provide mGFR assessment at M36 visit were excluded from the analysis.

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Assessed by protocol biopsies findings (Banff 1997 lesion scores and morphometry of the interstitial space)

Time frame: Month 12, Month 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Venous blood was drawn for donor specific (DSA) measurements prior to transplantation and at the final visit (36 months). The blood sample was first screened for the presence of PRA i.e. donor specific Immunoglobulin-G antibodies against specific HLA antigens. If PRA antibodies were detected, the blood sample was tested for specific DSAs on single antigen Luminex beads (coated with single HLA class I or II molecules). In this way, the specificity of these antibodies could be determined.

Time frame: Month 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

A BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III (Banff 97 classification). Biopsy graded IA: Significant interstitial infiltration (\> 25% of parenchyma) and foci of moderate tubulitis (\> 4 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IB: Significant interstitial infiltration (\> 25% of parenchyma) and foci of severe tubulitis (\> 10 mononuclear cells/tubular cross section or group of 10 tubular cells). Biopsy grade IIA: Mild to moderate intimal arteritis. Biopsy graded IIB: Severe intimal arteritis comprising \> 25% of the lumenal area.

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

The allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, the day of nephrectomy was the day of graft loss. Graft loss was considered an SAE (serious adverse event).

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Treatment failure was defined as graft loss or death.

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Change in renal progression measured by mean mGFR from week 7 to Month 36

Time frame: Week 7, Week 52, Month 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Proteinuria is when a large amount of protein, that should remain circulating in a person's blood, is spilled into their urine and eliminated from the body.

Time frame: Months 12, 24, 36

Population: The safety population (SAF) consists of all patients in whom TX was performed and who were randomized and treated with at least one dose of randomized treatment.

This is the time to first diagnosed malignancy. Malignancies (skin- or solid cancer) were listed whether they reoccurred in situ, were metastatic or de novo. This is shown as mean time.

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).

Treatment failure was defined as graft loss or death.Time to treatment failure is shown as mean time to treatment failure.

Time frame: Months 12, 24, 36

Population: The full analysis set (FAS) population consists of all randomized patients who received at least one dose of any immunosuppressive therapy after TX and have both baseline and Month 12 assessment of the primary efficacy variable (renal function based on mGFR).