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The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard CNI-based regimen in de novo renal transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus | Experimental | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively. |
|
| Reference Therapy | Active Comparator | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | One tablet containing 0.25, 0.5mg or 0.75 mg. Initially 2 mg/day. Afterwards based on blood level (target 6-10 ng/mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF) | The glomerular filtration rate (GFR) is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. The GFR, calculated according to the Nankivell formula, was used as the primary outcome measure in this study. This equation has been validated in renal transplant patients against the true GFR measured by a radionuclide method and has been confirmed as a very accurate method to calculate the GFR in this specific population (Gaspari et al., 2004)GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C Scr = serum creatinine concentration expressed in mmol/L. BW = body weight in kg, Surea = serum urea in mmol/L and Height is expressed in meters.The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of GFR by the Cockcroft-Gault Method (LOCF) | the GFR was also calculated using the Cockcroft-Gault method (Cockcroft and Gault 1976) and the Modification of Diet in Renal Disease (MDRD) method (Levey et al., 1999, Rodrigo et al., 2003; Pierrat et al., 2003).Cockcroft-Gault formula For men: GFR= (140-Age)X Body Weight[kg]/72X Serum Creatinine[mg/dl] For women: GFR= 0,85x(140-Age) x Body Weight[kg]/72x Serum Creatinine [mg/dl] The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Haifa | 31096 | Israel | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19667948 | Background | Bemelman FJ, de Maar EF, Press RR, van Kan HJ, ten Berge IJ, Homan van der Heide JJ, de Fijter HW. Minimization of maintenance immunosuppression early after renal transplantation: an interim analysis. Transplantation. 2009 Aug 15;88(3):421-8. doi: 10.1097/TP.0b013e3181af1df6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tacrolimus (FK506) | Drug | Capsules 0.5 mg, 1 mg. Dosing according to blood level. |
|
|
| Basiliximab | Drug | One vial containing 20 mg lyophilisate. 2 x 20 mg [day 0 (2 hrs prior to Tx) and day 4 post Tx] to be applied as 10 sec. bolus injection, i.v. |
|
|
| Enteric Coated Mycophenolate Sodium (EC-MPS) | Drug | One tablet containing 180 mg or 360 mg. 1440 mg/day (2x720 mg). If tolerated, dose reduction due to side effectis were possible (min. dose at BL@: 720 mg/day) |
|
|
| Corticosteroids | Drug | Used according to Israeli standards. A minimum dose of 5mg [prednisone, or equivalent, was used throughout the study period.](streamdown:incomplete-link) |
|
| 9 months |
| Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death. | Biopsy-proven acute rejection was defined as a biopsy gradeed IA, IB, IIA, IIB, or III. The allograft was presumed to be lost if the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss. | 9 months |
| Participants Who Had Occurrence of Treatment Failure. | Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection, graft loss, death, loss to follow up, discontinuation due to lack of efficacy or toxicity or conversion to another regimen. | 9 months |
| Change in Renal Function (Creatinine Slope) | X(slope)=(1/value of creatinine). | 3 months, 5 months, 7 months, 9 months |
| Petah Tikva |
| 49100 |
| Israel |
| Novartis Investigative Site | Tel Aviv | 64239 | Israel |
| FG001 | Reference Therapy | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids. |
| COMPLETED |
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| NOT COMPLETED |
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Enrolled patient population included all patients who signed an informed consent regardless whether renal transplanation as performed or not.
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| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively. |
| BG001 | Reference Therapy | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF) | The glomerular filtration rate (GFR) is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. The GFR, calculated according to the Nankivell formula, was used as the primary outcome measure in this study. This equation has been validated in renal transplant patients against the true GFR measured by a radionuclide method and has been confirmed as a very accurate method to calculate the GFR in this specific population (Gaspari et al., 2004)GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C Scr = serum creatinine concentration expressed in mmol/L. BW = body weight in kg, Surea = serum urea in mmol/L and Height is expressed in meters.The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis. | The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method). | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 9 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Assessment of GFR by the Cockcroft-Gault Method (LOCF) | the GFR was also calculated using the Cockcroft-Gault method (Cockcroft and Gault 1976) and the Modification of Diet in Renal Disease (MDRD) method (Levey et al., 1999, Rodrigo et al., 2003; Pierrat et al., 2003).Cockcroft-Gault formula For men: GFR= (140-Age)X Body Weight[kg]/72X Serum Creatinine[mg/dl] For women: GFR= 0,85x(140-Age) x Body Weight[kg]/72x Serum Creatinine [mg/dl] The Last Observation Carried Forward (LOCF) imputation technique was used for this analysis. | The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable | Posted | Mean | Standard Deviation | mL/min | 9 months |
| ||||||||||||||||||||||||||||||
| Secondary | Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death. | Biopsy-proven acute rejection was defined as a biopsy gradeed IA, IB, IIA, IIB, or III. The allograft was presumed to be lost if the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient underwent a graft nephrectomy, then the day of nephrectomy was the day of graft loss. | The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable | Posted | Number | Participants | 9 months |
| |||||||||||||||||||||||||||||||
| Secondary | Participants Who Had Occurrence of Treatment Failure. | Treatment failure was defined as a composite endpoint of biopsy-proven acute rejection, graft loss, death, loss to follow up, discontinuation due to lack of efficacy or toxicity or conversion to another regimen. | The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method) | Posted | Number | Participants | 9 months |
| |||||||||||||||||||||||||||||||
| Secondary | Change in Renal Function (Creatinine Slope) | X(slope)=(1/value of creatinine). | The ITT population comprised all randomized patients who received at least one dose of the study medications after randomization and had at least one post-baseline assessment of the primary efficacy variable (renal function based on Nankivell method). | Posted | Mean | Standard Deviation | mg/dl per month | 3 months, 5 months, 7 months, 9 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Everolimus | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively. | 7 | 19 | 19 | 19 | ||
| EG001 | Reference Therapy | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids. | 7 | 17 | 15 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 17.0 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | 17.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 17.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | 17.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 17.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 17.0 | Systematic Assessment |
| |
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 17.0 | Systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 17.0 | Systematic Assessment |
| |
| Craniotomy | Surgical and medical procedures | 17.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 17.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 17.0 | Systematic Assessment |
| |
| Monocytosis | Blood and lymphatic system disorders | 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 17.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | 17.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | 17.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | 17.0 | Systematic Assessment |
| |
| Diabetes mellitus | Endocrine disorders | 17.0 | Systematic Assessment |
| |
| Hypercalcaemia | Endocrine disorders | 17.0 | Systematic Assessment |
| |
| Orbital oedema | Eye disorders | 17.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Oral discomfort | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 17.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 17.0 | Systematic Assessment |
| |
| Oedema | General disorders | 17.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 17.0 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 17.0 | Systematic Assessment |
| |
| Human polyomavirus infection | Infections and infestations | 17.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 17.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | 17.0 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | 17.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 17.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase | Investigations | 17.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | 17.0 | Systematic Assessment |
| |
| Epstein-Barr virus test positive | Investigations | 17.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | 17.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | 17.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | 17.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | 17.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | 17.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 17.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 17.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 17.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | 17.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | 17.0 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | 17.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | 17.0 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | 17.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | 17.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | 17.0 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | 17.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | 17.0 | Systematic Assessment |
| |
| Vesicoureteric reflux | Renal and urinary disorders | 17.0 | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 17.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | 17.0 | Systematic Assessment |
| |
| Bladder anastomosis | Surgical and medical procedures | 17.0 | Systematic Assessment |
| |
| Urethral repair | Surgical and medical procedures | 17.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 17.0 | Systematic Assessment |
|
Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D016559 | Tacrolimus |
| D000077552 | Basiliximab |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids. |
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