Renal Transplantation
Conditions
Keywords
Basiliximab, renal transplantation, CNI-free, everolimus
Brief summary
The aims of this study are to extensively study the levels of CD25-Receptors saturation and expression obtained with 2 different doses of Simulect® in combination with Neoral® (i.e to demonstrate that saturation and expression vary according to the dose of Simulect® given), and to study the levels of CD25-Receptors saturation without Neoral® and compare them to the data with Neoral®. It will be conducted in low risk de novo adult renal transplant recipients until 12 weeks post-transplant, receiving either a cumulative dose of 40 or 80 mg of Simulect® in combination with Neoral®, or a cumulative dose of 80 mg of Simulect® in a calcineurin inhibitor free immunosuppressant therapy.
Interventions
DRUGSimulect®
Simulect® was provided to the study center in its commercial package containing a powder vial with 20 mg of active product and sterile water for injection. The solution should be used immediately after reconstitution. The infusion was prepared by adding at least 50 mL of physiologic or 5% glucose solution to the reconstituted solution (at least 100 mL for 40 mg of Simulect®). Simulect® was transported and kept in a cold environment (2-8°C) as recommended in the summary of product characteristics (SPC).
DRUGNeoral®
Neoral® was provided to the study center in its commercial package as 10, 25, 50 or 100 mg soft capsules in thermoformed blister packs.
DRUGCertican®
Certican® was provided to the study center in its commercial package as 0.75, 0.5 and 0.25 mg tablets in thermoformed blister packs.
DRUGMyfortic®
Myfortic® was administered orally b.i.d. with a 12-hour interval. Tablets could be taken either with or outside meals but consistently throughout the study. To maintain the integrity of the enteric coating, tablets were not to be crushed. Myfortic® treatment was initiated either preoperatively or within 24 hours post transplantation according to local practice in each center. Starting dose was to be 2160 mg/day (1080 mg b.i.d.) for at least 2 weeks and for at most 4 weeks. Patients were then to receive 1440 mg/day (720 mg b.i.d.) until the end of the study. Myfortic® was administered as concomitant treatment to all patients, using the same regimen for all 3 study groups. It was provided to the study center in its commercial package as 180 and 360 mg gastro-resistant tablets.
DRUGCorticosteroids
Corticosteroid i.v. therapy could be administered peri or per operatively according to local practice in each center with the same scheme for each patient in the center. Oral corticotherapy was to be initiated rapidly, within one week following transplantation, with a minimal dose of 20 mg/day. Thereafter, the dose was to be decreased according to local practice but oral corticosteroids were to be continued throughout the study with a minimal dose of 5 mg/day.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients receiving a primary renal graft from a deceased or living, related or unrelated donor and who require basiliximab induction therapy * Cold ischemia time \< 30 hours Exclusion (Non inclusion) criteria: * Patients undergoing multi-organ transplantation, including both kidneys, or who have previously undergone organ transplantation, including renal transplantation * Patients receiving a graft from a non-heart-beating donor * A-B-O incompatible graft or positive T cell crossmatch * Patients receiving a graft from an expanded criteria donor according to the UNOS definition (donor older than 60 years or donor aged between 50 and 60 years and presence of at least 2 of the following factors: hypertension, serum creatinine concentration ≥ 132 µmol/mL, cardiovascular cause of death) * Positive anti-HLA antibodies (Luminex) prior to transplantation * Patients whose original renal disease was primary focal and segmental hyalinosis or was related to atypical hemolytic uremic syndrome * EBV-negative patients receiving a graft from an EBV-positive donor (EBV D+R-) Other protocol-defined inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84 | Day 84 (Week 12) after transplantation | CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections. |
| Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation | CD25 saturation is the percentage of T cells expressing CD25 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | Day 0, Day 6, Day 42, Day 84 (Week 12) | Cell counts of various subpopulations of T, B and NK lymphocytes (CD3, CD4, CD8, CD19 and CD56) (flow cytometry). |
| Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Day 84 (Week 12), Week 24 post-transplantation | BPAR is one of the components of treatment failure. One assessment of efficacy was BPAR. Renal graft biopsies were performed and the renal tissue was examined to determine if there was acute rejection of the renal transplant. |
| AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84 | Day 84 (Week 12) post-transplantation | Mean AUC was calculated only for patients who received two Simulect injections. |
| Percentage of Participants With of Treatment Failures | Day 84 (Week 12), Week 24 | Treatment failure was defined either as a BPAR, a graft loss, a death or a loss to follow-up. An extended treatment failure was also defined including treated borderline lesions, BPAR, graft loss, death or loss to follow-up. Treated borderline lesions were considered as acute rejection by investigators and DMC experts. |
| Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24 | Day 8, Week 24 | (MDRDa formula) with imputation by last observation carried forward (LOCF) |
| Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12), Week 24 post-transplantation | Antibody mediated acute rejection: C4d deposition, presence of circulating antidonor antibody, morphologic evidence of acute tissue injury such as acute tubular necrosis-like minimal inflammation or capillary and/or glomerular inflammation and/or thromboses or arterial inflammation. Cellular acute rejection: acute T-cell mediated rejection Type IA: Significant interstitial infiltration (\> 25% of parenchyma) and foci of moderate tubulitis (\> 4 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IB: Significant interstitial infiltration (\> 25% of parenchyma) and foci of severe tubulitis (\> 10 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IIA: Mild to moderate intimal arteritis. Type IIB: Severe intimal arteritis comprising \> 25% of the lumenal area. Type III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation). |
| Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation | This is the percentage of T cells binding basiliximab at all timepoints. |
Countries
France
Participant flow
Recruitment details
With premature end of recruitment only 16 patients were included. Descriptive analysis was done & statistical method fitted the small number of patients. One final analysis was performed at M6 post-transplantation & comprised assessment of criteria planned at M3 and M6. Some analysis pertaining to the secondary objectives were not performed.
Participants by arm
| Arm | Count |
|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids | 3 |
| Simulect 80mg + Neoral + Myfortic + Steroids A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids | 6 |
| Simulect 80mg + Certican + Myfortic + Steroids A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids | 7 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Simulect 40mg + Neoral + Myfortic + Steroids | Simulect 80mg + Neoral + Myfortic + Steroids | Simulect 80mg + Certican + Myfortic + Steroids | Total |
|---|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 8.7 | 45.0 years STANDARD_DEVIATION 11.4 | 39.7 years STANDARD_DEVIATION 12.2 | 44.3 years STANDARD_DEVIATION 11.9 |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 6 / 6 | 6 / 7 |
| serious Total, serious adverse events | 2 / 3 | 2 / 6 | 5 / 7 |
Outcome results
Primary
Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84
CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections.
Time frame: Day 84 (Week 12) after transplantation
Population: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids | Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84 | 8.4 Weeks * Percentage of saturated CD25 | Standard Deviation 1.61 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84 | 11.1 Weeks * Percentage of saturated CD25 | Standard Deviation 1.12 |
| Simulect 80mg + Certican + Myfortic + Steroids | Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84 | 9.7 Weeks * Percentage of saturated CD25 | Standard Deviation 0.7 |
Primary
Saturation Rate of CD25 Antigen Saturation by Basiliximab
CD25 saturation is the percentage of T cells expressing CD25
Time frame: Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation
Population: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 4 (2 hours after injection): (n= 3, 6, 5) | 96.7 percentage of T cells | Standard Deviation 5.77 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 0 (2 hours after injection) | 93.7 percentage of T cells | Standard Deviation 10.97 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 21: (n= 3, 6, 6) | 100.0 percentage of T cells | Standard Deviation 0 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 6: (n= 3, 6, 6) | 98.7 percentage of T cells | Standard Deviation 2.31 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 56: (n= 3, 6, 5) | 65.0 percentage of T cells | Standard Deviation 56.35 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 14: (n= 3, 6, 6) | 98.3 percentage of T cells | Standard Deviation 2.89 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 1 | 95.7 percentage of T cells | Standard Deviation 7.51 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 0 (before injection) | 0.0 percentage of T cells | Standard Deviation 0 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 42: (n= 3, 6, 5) | 78.3 percentage of T cells | Standard Deviation 9.07 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 4 (before injection); (n= 3, 6, 6) | 100.0 percentage of T cells | Standard Deviation 0 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 84 (Week 12): (n= 3, 6, 5) | 0.0 percentage of T cells | Standard Deviation 0 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 28: (n= 3, 6, 6) | 95.3 percentage of T cells | Standard Deviation 4.16 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 0 (2 hours after injection) | 96.7 percentage of T cells | Standard Deviation 8.16 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 0 (before injection) | 0.0 percentage of T cells | Standard Deviation 0 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 1 | 97.7 percentage of T cells | Standard Deviation 5.24 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 4 (before injection); (n= 3, 6, 6) | 96.2 percentage of T cells | Standard Deviation 6.88 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 4 (2 hours after injection): (n= 3, 6, 5) | 96.3 percentage of T cells | Standard Deviation 6.83 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 6: (n= 3, 6, 6) | 100.0 percentage of T cells | Standard Deviation 0 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 14: (n= 3, 6, 6) | 96.7 percentage of T cells | Standard Deviation 7.23 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 21: (n= 3, 6, 6) | 94.5 percentage of T cells | Standard Deviation 10.8 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 28: (n= 3, 6, 6) | 100.0 percentage of T cells | Standard Deviation 0 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 42: (n= 3, 6, 5) | 100.0 percentage of T cells | Standard Deviation 0 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 56: (n= 3, 6, 5) | 93.3 percentage of T cells | Standard Deviation 13.2 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 84 (Week 12): (n= 3, 6, 5) | 67.5 percentage of T cells | Standard Deviation 48.55 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 4 (before injection); (n= 3, 6, 6) | 93.7 percentage of T cells | Standard Deviation 9.89 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 56: (n= 3, 6, 5) | 94.2 percentage of T cells | Standard Deviation 12.97 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 28: (n= 3, 6, 6) | 92.7 percentage of T cells | Standard Deviation 9.33 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 1 | 99.0 percentage of T cells | Standard Deviation 2.65 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 0 (before injection) | 0.0 percentage of T cells | Standard Deviation 0 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 42: (n= 3, 6, 5) | 99.2 percentage of T cells | Standard Deviation 1.79 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 6: (n= 3, 6, 6) | 94.0 percentage of T cells | Standard Deviation 14.7 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 0 (2 hours after injection) | 94.7 percentage of T cells | Standard Deviation 5.19 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 14: (n= 3, 6, 6) | 97.3 percentage of T cells | Standard Deviation 6.53 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 4 (2 hours after injection): (n= 3, 6, 5) | 84.8 percentage of T cells | Standard Deviation 19.25 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 84 (Week 12): (n= 3, 6, 5) | 14.2 percentage of T cells | Standard Deviation 20.86 |
| Simulect 80mg + Certican + Myfortic + Steroids | Saturation Rate of CD25 Antigen Saturation by Basiliximab | Day 21: (n= 3, 6, 6) | 92.5 percentage of T cells | Standard Deviation 11.83 |
Secondary
AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84
Mean AUC was calculated only for patients who received two Simulect injections.
Time frame: Day 84 (Week 12) post-transplantation
Population: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids | AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84 | 7.0 Weeks * Percentage of T cells | Standard Deviation 1.8 |
| Simulect 80mg + Neoral + Myfortic + Steroids | AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84 | 9.9 Weeks * Percentage of T cells | Standard Deviation 2.22 |
| Simulect 80mg + Certican + Myfortic + Steroids | AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84 | 8.4 Weeks * Percentage of T cells | Standard Deviation 0.75 |
Secondary
Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24
(MDRDa formula) with imputation by last observation carried forward (LOCF)
Time frame: Day 8, Week 24
Population: Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids | Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24 | Day 8 | 35.0 mL/min/1.73m^2 | Standard Deviation 13.2 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24 | Week 24 (n= 3, 6, 6) | 31.9 mL/min/1.73m^2 | Standard Deviation 27.93 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24 | Day 8 | 53.8 mL/min/1.73m^2 | Standard Deviation 23.79 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24 | Week 24 (n= 3, 6, 6) | 55.7 mL/min/1.73m^2 | Standard Deviation 15.68 |
| Simulect 80mg + Certican + Myfortic + Steroids | Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24 | Day 8 | 49.9 mL/min/1.73m^2 | Standard Deviation 18.45 |
| Simulect 80mg + Certican + Myfortic + Steroids | Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24 | Week 24 (n= 3, 6, 6) | 54.4 mL/min/1.73m^2 | Standard Deviation 10.48 |
Secondary
Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity
Antibody mediated acute rejection: C4d deposition, presence of circulating antidonor antibody, morphologic evidence of acute tissue injury such as acute tubular necrosis-like minimal inflammation or capillary and/or glomerular inflammation and/or thromboses or arterial inflammation. Cellular acute rejection: acute T-cell mediated rejection Type IA: Significant interstitial infiltration (\> 25% of parenchyma) and foci of moderate tubulitis (\> 4 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IB: Significant interstitial infiltration (\> 25% of parenchyma) and foci of severe tubulitis (\> 10 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IIA: Mild to moderate intimal arteritis. Type IIB: Severe intimal arteritis comprising \> 25% of the lumenal area. Type III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation).
Time frame: Day 84 (Week 12), Week 24 post-transplantation
Population: Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Antibody mediated AR - No | 66.7 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Cellular AR - Yes | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type lA | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type lB | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type llA | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type lA | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type llB | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type lll | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type lB | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type llA | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Antibody mediated AR - Yes | 33.3 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type llB | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type lll (C AR) | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Cellular AR - No | 100.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Antibody mediated AR - No | 66.7 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Cellular AR - No | 100.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Antibody mediated AR - Yes | 33.3 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Cellular AR - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Cellular AR - No | 83.3 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Cellular AR - Yes | 16.7 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type lB | 16.7 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Cellular AR - No | 83.3 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type lA | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Cellular AR - Yes | 16.7 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type llA | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type lB | 16.7 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Antibody mediated AR - No | 100.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Antibody mediated AR - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type llA | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Antibody mediated AR - No | 100.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type llB | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type llB | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type lA | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Antibody mediated AR - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type lll | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type lll (C AR) | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type lll | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Antibody mediated AR - No | 85.7 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Antibody mediated AR - Yes | 14.3 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Cellular AR - No | 57.1 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Cellular AR - Yes | 42.9 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type lA | 14.3 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type llA | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type llB | 14.3 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type lll (C AR) | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Antibody mediated AR - No | 85.7 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Antibody mediated AR - Yes | 14.3 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Cellular AR - No | 57.1 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Cellular AR - Yes | 42.9 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type lA | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type lB | 28.6 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type llA | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Week 24: Banff type llB | 14.3 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity | Day 84 (Week 12): Banff type lB | 14.3 Percentage of participants |
Secondary
Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)
BPAR is one of the components of treatment failure. One assessment of efficacy was BPAR. Renal graft biopsies were performed and the renal tissue was examined to determine if there was acute rejection of the renal transplant.
Time frame: Day 84 (Week 12), Week 24 post-transplantation
Population: Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Week 24: No | 66.7 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Day 84 (Week 12): No | 66.7 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Week 24:Yes | 33.3 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Day 84 (Week 12):Yes | 33.3 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Week 24: No | 83.3 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Day 84 (Week 12):Yes | 16.7 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Day 84 (Week 12): No | 83.3 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Week 24:Yes | 16.7 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Week 24:Yes | 57.1 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Day 84 (Week 12): No | 42.9 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Day 84 (Week 12):Yes | 57.1 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR) | Week 24: No | 42.9 Percentage of participants |
Secondary
Percentage of Participants With of Treatment Failures
Treatment failure was defined either as a BPAR, a graft loss, a death or a loss to follow-up. An extended treatment failure was also defined including treated borderline lesions, BPAR, graft loss, death or loss to follow-up. Treated borderline lesions were considered as acute rejection by investigators and DMC experts.
Time frame: Day 84 (Week 12), Week 24
Population: Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Death - No | 100.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day84 (Week 12):BPAR and/or borderline lesions-Yes | 33.3 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Graft loss - No | 66.7 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Graft loss - Yes | 33.3 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day84 (Week 12): BPAR and/or borderline lesions-No | 66.7 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Death - Yes | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Loss to follow-up - No | 100.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Loss to follow-up - Yes | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: BPAR or borderline lesions - No | 66.7 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Graft loss - No | 66.7 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Death - No | 100.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Loss to follow-up - No | 100.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Loss to follow-up - Yes | 0.0 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: BPAR or borderline lesions - Yes | 33.3 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Graft loss - Yes | 33.3 Percentage of participants |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Death - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Death - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Loss to follow-up - No | 100.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Loss to follow-up - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: BPAR or borderline lesions - Yes | 33.3 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: BPAR or borderline lesions - No | 66.7 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Graft loss - No | 100.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Death - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Death - No | 100.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day84 (Week 12): BPAR and/or borderline lesions-No | 66.7 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Graft loss - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day84 (Week 12):BPAR and/or borderline lesions-Yes | 33.3 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Loss to follow-up - No | 100.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Graft loss - No | 100.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Graft loss - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Death - No | 100.0 Percentage of participants |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Loss to follow-up - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Death - No | 100.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Death - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Loss to follow-up - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Graft loss - No | 100.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Loss to follow-up - No | 100.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Death - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day84 (Week 12): BPAR and/or borderline lesions-No | 14.3 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Loss to follow-up - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Loss to follow-up - No | 100.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Death - No | 100.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: BPAR or borderline lesions - No | 14.3 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: BPAR or borderline lesions - Yes | 85.7 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day84 (Week 12):BPAR and/or borderline lesions-Yes | 85.7 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Graft loss - No | 100.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Day 84 (Week 12): Graft loss - Yes | 0.0 Percentage of participants |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of Participants With of Treatment Failures | Week 24: Graft loss - Yes | 0.0 Percentage of participants |
Secondary
Percentage of T-cells That Bind Basiliximab to CD25 Receptors
This is the percentage of T cells binding basiliximab at all timepoints.
Time frame: Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation
Population: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 0 (before injection) | 0.0 Percentage of T cells | Standard Deviation 0 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 0 (2 hours after injection) | 95.3 Percentage of T cells | Standard Deviation 8.08 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 1 (n= 3, 5, 7) | 70.0 Percentage of T cells | Standard Deviation 28.58 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 4 (before injection): (n= 3, 6, 6) | 100.0 Percentage of T cells | Standard Deviation 0 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 4 (2 hours after injection): (n= 3, 5, 5) | 100.0 Percentage of T cells | Standard Deviation 0 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 6: (n= 3, 6, 6) | 91.7 Percentage of T cells | Standard Deviation 14.43 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 14: (n= 3, 6, 6) | 100.0 Percentage of T cells | Standard Deviation 0 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 21: (n= 3, 6, 6) | 89.0 Percentage of T cells | Standard Deviation 19.05 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 28: (n= 3, 6, 6) | 76.3 Percentage of T cells | Standard Deviation 17.62 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 42: (n= 3, 6, 5) | 47.3 Percentage of T cells | Standard Deviation 28.22 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 56: (n= 3, 6, 5) | 53.0 Percentage of T cells | Standard Deviation 41.8 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 84 (Week 12): (n= 3, 6, 5) | 6.7 Percentage of T cells | Standard Deviation 6.11 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 84 (Week 12): (n= 3, 6, 5) | 57.7 Percentage of T cells | Standard Deviation 43.83 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 0 (before injection) | 0.0 Percentage of T cells | Standard Deviation 0 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 14: (n= 3, 6, 6) | 89.0 Percentage of T cells | Standard Deviation 22 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 28: (n= 3, 6, 6) | 91.0 Percentage of T cells | Standard Deviation 14 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 0 (2 hours after injection) | 96.2 Percentage of T cells | Standard Deviation 9.39 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 6: (n= 3, 6, 6) | 99.0 Percentage of T cells | Standard Deviation 2.45 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 56: (n= 3, 6, 5) | 88.8 Percentage of T cells | Standard Deviation 27.35 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 1 (n= 3, 5, 7) | 64.8 Percentage of T cells | Standard Deviation 35.15 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 21: (n= 3, 6, 6) | 87.7 Percentage of T cells | Standard Deviation 26.93 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 4 (2 hours after injection): (n= 3, 5, 5) | 83.4 Percentage of T cells | Standard Deviation 20.14 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 4 (before injection): (n= 3, 6, 6) | 59.0 Percentage of T cells | Standard Deviation 45.98 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 42: (n= 3, 6, 5) | 84.0 Percentage of T cells | Standard Deviation 19.75 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 4 (before injection): (n= 3, 6, 6) | 53.0 Percentage of T cells | Standard Deviation 33.33 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 4 (2 hours after injection): (n= 3, 5, 5) | 81.2 Percentage of T cells | Standard Deviation 16.02 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 42: (n= 3, 6, 5) | 78.8 Percentage of T cells | Standard Deviation 30.11 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 6: (n= 3, 6, 6) | 98.3 Percentage of T cells | Standard Deviation 4.08 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 14: (n= 3, 6, 6) | 93.8 Percentage of T cells | Standard Deviation 15.11 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 21: (n= 3, 6, 6) | 85.8 Percentage of T cells | Standard Deviation 32.31 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 56: (n= 3, 6, 5) | 75.2 Percentage of T cells | Standard Deviation 15.29 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 0 (before injection) | 4.7 Percentage of T cells | Standard Deviation 12.47 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 0 (2 hours after injection) | 81.6 Percentage of T cells | Standard Deviation 28.3 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 28: (n= 3, 6, 6) | 82.7 Percentage of T cells | Standard Deviation 26.29 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 1 (n= 3, 5, 7) | 91.4 Percentage of T cells | Standard Deviation 11.65 |
| Simulect 80mg + Certican + Myfortic + Steroids | Percentage of T-cells That Bind Basiliximab to CD25 Receptors | Day 84 (Week 12): (n= 3, 6, 5) | 15.8 Percentage of T cells | Standard Deviation 9.73 |
Secondary
Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells
Cell counts of various subpopulations of T, B and NK lymphocytes (CD3, CD4, CD8, CD19 and CD56) (flow cytometry).
Time frame: Day 0, Day 6, Day 42, Day 84 (Week 12)
Population: PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 42: (n= 3, 6, 5) | 0.1 10^9 cells/L | Standard Deviation 0.09 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.6 10^9 cells/L | Standard Deviation 0.36 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 0 (before injection) | 0.5 10^9 cells/L | Standard Deviation 0.25 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 6: (n=3, 6, 6) | 0.1 10^9 cells/L | Standard Deviation 0.07 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 0 (before injection) | 0.1 10^9 cells/L | Standard Deviation 0.05 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.8 10^9 cells/L | Standard Deviation 0.58 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 0 (before injection) | 0.1 10^9 cells/L | Standard Deviation 0.08 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 6: (n= 3, 6, 6) | 0.2 10^9 cells/L | Standard Deviation 0.08 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.1 10^9 cells/L | Standard Deviation 0.05 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.2 10^9 cells/L | Standard Deviation 0.24 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 42: (n= 3, 6, 5) | 0.1 10^9 cells/L | Standard Deviation 0.05 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 6: (n= 3, 6, 6) | 0.1 10^9 cells/L | Standard Deviation 0 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 0 (before injection) | 0.4 10^9 cells/L | Standard Deviation 0.19 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 42: (n= 3, 6, 5) | 0.1 10^9 cells/L | Standard Deviation 0.05 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 0 (before injection) | 0.1 10^9 cells/L | Standard Deviation 0.2 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 6: (n= 3, 6, 6) | 0.5 10^9 cells/L | Standard Deviation 0.3 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 42: (n= 3, 6, 5) | 0.5 10^9 cells/L | Standard Deviation 0.09 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.2 10^9 cells/L | Standard Deviation 0.2 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 42: (n= 3, 6, 5) | 0.3 10^9 cells/L | Standard Deviation 0.08 |
| Simulect 40mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 6: (n= 3, 6, 6) | 0.6 10^9 cells/L | Standard Deviation 0.39 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 6: (n= 3, 6, 6) | 0.1 10^9 cells/L | Standard Deviation 0.06 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 0 (before injection) | 0.9 10^9 cells/L | Standard Deviation 0.28 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 6: (n= 3, 6, 6) | 1.1 10^9 cells/L | Standard Deviation 0.5 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 42: (n= 3, 6, 5) | 1.2 10^9 cells/L | Standard Deviation 0.96 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 1.2 10^9 cells/L | Standard Deviation 0.72 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 0 (before injection) | 0.6 10^9 cells/L | Standard Deviation 0.2 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 6: (n= 3, 6, 6) | 0.7 10^9 cells/L | Standard Deviation 0.28 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 42: (n= 3, 6, 5) | 0.8 10^9 cells/L | Standard Deviation 0.53 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.8 10^9 cells/L | Standard Deviation 0.42 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 0 (before injection) | 0.3 10^9 cells/L | Standard Deviation 0.13 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 6: (n= 3, 6, 6) | 0.3 10^9 cells/L | Standard Deviation 0.25 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 42: (n= 3, 6, 5) | 0.3 10^9 cells/L | Standard Deviation 0.44 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.3 10^9 cells/L | Standard Deviation 0.32 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 0 (before injection) | 0.1 10^9 cells/L | Standard Deviation 0.1 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 6: (n=3, 6, 6) | 0.2 10^9 cells/L | Standard Deviation 0.27 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 42: (n= 3, 6, 5) | 0.2 10^9 cells/L | Standard Deviation 0.21 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.1 10^9 cells/L | Standard Deviation 0.11 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 0 (before injection) | 0.2 10^9 cells/L | Standard Deviation 0.14 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 42: (n= 3, 6, 5) | 0.2 10^9 cells/L | Standard Deviation 0.1 |
| Simulect 80mg + Neoral + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.1 10^9 cells/L | Standard Deviation 0.03 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 6: (n= 3, 6, 6) | 0.9 10^9 cells/L | Standard Deviation 0.75 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 6: (n=3, 6, 6) | 0.2 10^9 cells/L | Standard Deviation 0.17 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 42: (n= 3, 6, 5) | 0.8 10^9 cells/L | Standard Deviation 0.82 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.1 10^9 cells/L | Standard Deviation 0.15 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 42: (n= 3, 6, 5) | 0.2 10^9 cells/L | Standard Deviation 0.18 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 6: (n= 3, 6, 6) | 0.6 10^9 cells/L | Standard Deviation 0.59 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 42: (n= 3, 6, 5) | 0.2 10^9 cells/L | Standard Deviation 0.13 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.1 10^9 cells/L | Standard Deviation 0.15 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 0 (before injection) | 0.5 10^9 cells/L | Standard Deviation 0.22 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 0 (before injection) | 0.7 10^9 cells/L | Standard Deviation 0.28 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 0 (before injection) | 0.2 10^9 cells/L | Standard Deviation 0.31 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 1.1 10^9 cells/L | Standard Deviation 1.22 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 42: (n= 3, 6, 5) | 0.4 10^9 cells/L | Standard Deviation 0.37 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 6: (n= 3, 6, 6) | 0.2 10^9 cells/L | Standard Deviation 0.24 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD3 cells count at Day 42: (n= 3, 6, 5) | 1.1 10^9 cells/L | Standard Deviation 1.18 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.3 10^9 cells/L | Standard Deviation 0.37 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD8 cells count at Day 0 (before injection) | 0.2 10^9 cells/L | Standard Deviation 0.15 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD56 cells count at Day 6: (n= 3, 6, 6) | 0.2 10^9 cells/L | Standard Deviation 0.25 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD19 cells count at Day 0 (before injection) | 0.1 10^9 cells/L | Standard Deviation 0.05 |
| Simulect 80mg + Certican + Myfortic + Steroids | Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells | CD4 cells count at Day 84 (Week 12): (n= 3, 6, 6) | 0.7 10^9 cells/L | Standard Deviation 0.86 |