Study to Evaluate the Efficacy, Safety and Tolerability o... | NCT00956293

Label	Type	Description	Intervention Names
Control group	Active Comparator	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.	Drug: Basiliximab Drug: Enteric Coated Mycophenolic Acid (MPA) Drug: Cyclosporin A (CsA) Drug: Corticosteroids
Everolimus group	Experimental	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.	Drug: Basiliximab Drug: Enteric Coated Mycophenolic Acid (MPA) Drug: RAD001 Drug: Cyclosporin A (CsA) Drug: Corticosteroids

Name	Type	Description	Arm Group Labels	Other Names
Basiliximab	Drug	On day 0, 2 hours prior to transplant and day 4 post-transplant, 20 mg x2 were given to all participants. Post randomization, 20mg at weeks 7 and 12 were given to the Everolimus group.

Measure	Description	Time Frame
Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method	The study was terminated prematurely and not powered for efficacy.	Month 6

Measure	Description	Time Frame
Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method	The study was terminated prematurely and not powered for efficacy.	Month 6
Renal Function by Serum Creatinine

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Aachen		52074	Germany
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
31536556	Derived	Brakemeier S, Arns W, Lehner F, Witzke O, Vonend O, Sommerer C, Muhlfeld A, Rath T, Schuhmann R, Zukunft B, Kroeger I, Porstner M, Budde K. Everolimus in de novo kidney transplant recipients participating in the Eurotransplant senior program: Results of a prospective randomized multicenter study (SENATOR). PLoS One. 2019 Sep 19;14(9):e0222730. doi: 10.1371/journal.pone.0222730. eCollection 2019.

ID	Title	Description
FG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
FG001

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 by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method

The study was terminated prematurely and not powered for efficacy.

This outcome measure was not analyzed because a total of 244 completed subjects were needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done.

Posted

Month 6

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts
Participants	OG0000 OG0010

Secondary

Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method

The study was terminated prematurely and not powered for efficacy.

Posted

Month 6

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts

Secondary

Renal Function by Serum Creatinine

The study was terminated prematurely and not powered for efficacy.

Posted

Months 6, 12, 24, 36, 48 and 60

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts
Participants

Secondary

Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death

The study was terminated prematurely and not powered for efficacy.

Posted

Months 6, 12, 24, 36, 48 and 60

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts

Secondary

Occurrence of Treatment Failures

The study was terminated prematurely and not powered for efficacy.

Posted

Month 6

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts
Participants

Secondary

Evolution of Renal Function (Creatinine Slope)

The study was terminated prematurely and not powered for efficacy.

Posted

Week 7, Month 6

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts
Participants

Secondary

CD25 Saturation on Lymphocytes

Posted

Month 6

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts
Participants

Secondary

Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death

Participants with adverse events (serious plus non-serious), serious adverse events and death were reported.

Randomized Safety Set: This set included all randomized participants who received at least one dose of study medication.

Posted

Number

Participants

Months 6, 12, 24, 36, 48 and 60

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts
Participants

Secondary

Renal Function by GFR Over Time

Posted

Months 12, 24, 36, 48 and 60

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts
Participants

Secondary

Renal Function by Proteinuria

Posted

Months12, 24, 36, 48 and 60

ID	Title	Description
OG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
OG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0012 affected51 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0013 affected51 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0012 affected51 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0010 affected51 at risk
ABDOMINAL MASS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
APHTHOUS STOMATITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0012 affected51 at risk
ENTEROCOLITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
PYREXIA	General disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
TRANSPLANT REJECTION	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0010 affected51 at risk
BK VIRUS INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
BRONCHOPULMONARY ASPERGILLOSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
CYTOMEGALOVIRUS COLITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
FEBRILE INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
GENITAL HERPES	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
HEPATIC CYST INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0010 affected51 at risk
HERPES ZOSTER OTICUS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected24 at risk EG0011 affected51 at risk
PNEUMONIA	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected24 at risk EG0014 affected51 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected24 at risk EG0015 affected51 at risk
UROSEPSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
GRAFT DYSFUNCTION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0004 affected24 at risk EG0015 affected51 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
FACIAL NERVE DISORDER	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
ACUTE PRERENAL FAILURE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
ANURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0010 affected51 at risk
NEPHROSCLEROSIS	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0010 affected51 at risk
RENAL ARTERY STENOSIS	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0011 affected51 at risk
URETERIC STENOSIS	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0012 affected51 at risk
URINARY TRACT DISORDER	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk
PULMONARY ARTERIAL HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0010 affected51 at risk
ARTERIOVENOUS FISTULA	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0011 affected51 at risk
LYMPHOCELE	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0011 affected51 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected24 at risk EG0016 affected51 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0004 affected24 at risk EG00120 affected51 at risk
APHTHOUS STOMATITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0019 affected51 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0013 affected51 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG00110 affected51 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0014 affected51 at risk
NAUSEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0013 affected51 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA	Systematic Assessment	EG0007 affected24 at risk EG00113 affected51 at risk
PYREXIA	General disorders	MedDRA	Systematic Assessment	EG0004 affected24 at risk EG0015 affected51 at risk
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected24 at risk EG0014 affected51 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0015 affected51 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected24 at risk EG00122 affected51 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0015 affected51 at risk
HYPERLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0013 affected51 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0014 affected51 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0013 affected51 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG00112 affected51 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0013 affected51 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0014 affected51 at risk
IRON DEFICIENCY	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0015 affected51 at risk
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0013 affected51 at risk
INSOMNIA	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected24 at risk EG0013 affected51 at risk
PROTEINURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0018 affected51 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected24 at risk EG0013 affected51 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected24 at risk EG0013 affected51 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected24 at risk EG0011 affected51 at risk
HYPERTENSION	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected24 at risk EG0016 affected51 at risk

ID	Term
D000077552	Basiliximab
D009173	Mycophenolic Acid
D000068338	Everolimus
D016572	Cyclosporine
D000305	Adrenal Cortex Hormones

ID	Term
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
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description
BG000	Control Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
BG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Control Goup	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.			11	24	15	24
EG001	Everolimus Group	During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.			28	51	50	51

ID	Type	Description	Link
EudraCT-NO. 2008-005109-20
2008-005109-20