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24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients (EVITA)

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ClinicalTrials.gov Identifier: NCT01169701
Recruitment Status : Completed
First Posted : July 26, 2010
Results First Posted : April 30, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Transplant
Interventions Drug: Everolimus
Drug: Tacrolimus
Drug: Mycophenolic acid (MPA)
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml). Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Period Title: Overall Study
Started 36 35
Safety Set 36 35
Intent to Treat (ITT) Set 32 28
Completed 31 25
Not Completed 5 10
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             1             3
Adverse Event             1             2
Exclusion criteria             2             0
Death             0             1
Administrative problems             0             1
Serious adverse event             0             1
Sponsor decision             0             1
Arm/Group Title Tacrolimus Everolimus Total
Hide Arm/Group Description Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml). Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation. Total of all reporting groups
Overall Number of Baseline Participants 36 35 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 35 participants 71 participants
49.1  (12.0) 47.4  (13.2) 48.3  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
Female
16
  44.4%
13
  37.1%
29
  40.8%
Male
20
  55.6%
22
  62.9%
42
  59.2%
1.Primary Outcome
Title Change From Baseline in Left Ventricular Mass Index (LVMI)
Hide Description Left ventricular hypertrophy grade was assessed by echocardiogram where the left ventricular mass index was calculated. The presence of LVM was defined as > 49.2 g/m^2.7 in men and >46.7 g/m^2.7 in women. A negative change from baseline indicates improvement.
Time Frame Baseline, Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent to Treat (ITT) analysis set, who had both baseline and month 24 values, were analyzed. The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 31 25
Mean (Standard Deviation)
Unit of Measure: g/m^2.7
-6.071  (20.116) -4.008  (17.610)
2.Secondary Outcome
Title Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure
Hide Description Blood pressure was measured using ambulatory blood pressure monitoring (ABPM). A negative change from baseline indicates improvement.
Time Frame Baseline, Month 6, month 12, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 31 30
Mean (Standard Deviation)
Unit of Measure: mmHg
Month 6 (n=31,29) -0.6  (9.1) 3.2  (8.6)
Month 12 (n=28,24) 2.1  (6.9) 2.7  (10.4)
Month 24 (n=29,24) 2.2  (10.6) 2.0  (8.7)
3.Secondary Outcome
Title Pulse Wave Velocity (PWV)
Hide Description Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.
Time Frame Month 6, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: m/sec
Month 6 (n=31,30) 7.01  (1.62) 7.40  (1.62)
Month 24 (n=28,25) 7.58  (1.68) 7.06  (1.74)
4.Secondary Outcome
Title Percentage of Participants With Major Cardiovascular Events (MACE)
Hide Description The percentage of participants who experienced MACE were reported. MACE included acute myocardial infarction, insertion or replacement of implantable defibrillator, peripheral vascular disorders, congestive heart failure, coronary artery bypass, other events, percutaneous coronary intervention and stroke.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat (ITT) analysis set: The ITT included participants who received at least one dose of study medication and had at least one post baseline LVMI value.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 32 28
Measure Type: Number
Unit of Measure: Percentage of participants
0.00 0.00
5.Secondary Outcome
Title Renal Function Measured by Serum Creatinine
Hide Description Serum samples were collected to analyze serum creatinine.
Time Frame Month 6, month 12, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: mg/dl
Month 6 (n=33,29) 1.232  (0.272) 1.234  (0.360)
Month 12 (n=32,28) 1.231  (0.278) 1.256  (0.367)
Month 24 (n= 31,26) 1.217  (0.235) 1.260  (0.358)
6.Secondary Outcome
Title Renal Function as Measured by Creatinine Clearance
Hide Description Creatinine clearance was calculated using the Cockroft-Gault formula.
Time Frame Month 6, month 12, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: mg/min
Month 6 (n=29,25) 64.841  (16.163) 76.618  (27.708)
Month 12 (n=28,25) 65.037  (15.866) 73.363  (25.989)
Month 24 (n=28,24) 66.933  (13.264) 72.910  (23.926)
7.Secondary Outcome
Title Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)
Hide Description Estimated GFR was caluclated using the modification of diet in renal disease (MDRD) formula.
Time Frame Month 6, month 12, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
Month 6 (n=33,29) 55.648  (11.244) 63.781  (18.380)
Month 12 (n=32,28) 57.757  (11.391) 61.225  (19.239)
Month 24 (n=31,26) 57.727  (10.498) 60.779  (17.023)
8.Secondary Outcome
Title Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP)
Hide Description Blood samples were collected to analyze Troponin I and collagen type 1 C-telopeptide (ICTP). A negative change from baseline indicates improvement.
Time Frame Baseline, month 6, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: ng/ml
Troponin 1, Month 6 (n=27,30) 0.000  (0.010) -0.006  (0.026)
Troponin 1, Month 24 (n=24,24) 0.003  (0.026) -0.007  (0.018)
ICTP, Month 6 (n=27,30) 0.049  (0.341) -0.195  (0.234)
ICTP, Month 24 (n=24,24) -0.035  (0.366) -0.125  (0.323)
9.Secondary Outcome
Title Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c)
Hide Description Blood samples were collected to analyze HbA1c. A negative change from baseline indicates improvement.
Time Frame Baseline, month 6, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: Percentage of HbA1c
Month 6 (n=20,22) 0.015  (0.184) 0.159  (0.346)
Month12 (n=22,20) 0.045  (0.237) 0.185  (0.407)
10.Secondary Outcome
Title Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO)
Hide Description Blood samples were collected to analyze MPO. A negative change from baseline indicates improvement.
Time Frame Baseline, month 6, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: U/mL
Month 6 (n=27,30) 0.433  (2.189) -0.093  (1.158)
Month 24 (n=24,24) -0.329  (0.280) -0.642  (0.972)
11.Secondary Outcome
Title Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP)
Hide Description Blood samples were collected to analyze NT-proBNP. A negative change from baseline indicates improvement.
Time Frame Baseline, month 6, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: pg/mL
Month 6 (n=27,30) 21.604  (294.82) -79.10  (401.44)
Month 24 (n=24,24) -80.20  (424.24) -193.3  (590.90)
12.Secondary Outcome
Title Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP)
Hide Description Blood samples were collected to analyze PCR. A negative change from baseline indicates improvement.
Time Frame Baseline, month 6, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: ug/l
Month 6 (n=27,30) -13.82  (34.110) -33.36  (33.227)
Month 24 (n=24,24) -13.65  (40.675) -28.17  (30.381)
13.Secondary Outcome
Title Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP)
Hide Description Blood samples were collected to analyze CRP. A negative change from baseline indicates improvement.
Time Frame Baseline, month 6, month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: mg/dl
Month 6 (n=27,30) 0.512  (2.342) 0.326  (1.129)
Month 24 (n=24,24) 0.100  (0.469) -0.040  (1.683)
14.Secondary Outcome
Title Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up
Hide Description The incidence of BPAR, graft loss, death and lost to follow-up events was calculated using relative frequency.
Time Frame Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description:
Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
Overall Number of Participants Analyzed 32 28
Measure Type: Number
Unit of Measure: Percentage of participants
BPAR 0.00 0.00
Graft loss 0.00 0.00
Deaths 0.00 0.00
Lost to follow-up 3.13 0.00
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tacrolimus Everolimus
Hide Arm/Group Description Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml). Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
All-Cause Mortality
Tacrolimus Everolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tacrolimus Everolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   5/36 (13.89%)   8/35 (22.86%) 
General disorders     
Pyrexia  1  1/36 (2.78%)  0/35 (0.00%) 
Immune system disorders     
Drug hypersensitivity  1  0/36 (0.00%)  1/35 (2.86%) 
Infections and infestations     
Oral herpes  1  0/36 (0.00%)  1/35 (2.86%) 
Pneumonia  1  0/36 (0.00%)  1/35 (2.86%) 
Pyelonephritis  1  1/36 (2.78%)  0/35 (0.00%) 
Respiratory syncytial virus infection  1  0/36 (0.00%)  1/35 (2.86%) 
Septic shock  1  0/36 (0.00%)  1/35 (2.86%) 
Urosepsis  1  0/36 (0.00%)  1/35 (2.86%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/36 (2.78%)  0/35 (0.00%) 
Central nervous system lymphoma  1  1/36 (2.78%)  0/35 (0.00%) 
Metastatic neoplasm  1  0/36 (0.00%)  1/35 (2.86%) 
Nervous system disorders     
Cerebrovascular accident  1  1/36 (2.78%)  0/35 (0.00%) 
Renal and urinary disorders     
Haematuria  1  0/36 (0.00%)  1/35 (2.86%) 
Renal impairment  1  0/36 (0.00%)  1/35 (2.86%) 
Urinary tract obstruction  1  0/36 (0.00%)  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/36 (2.78%)  1/35 (2.86%) 
Surgical and medical procedures     
Arteriovenous fistula operation  1  0/36 (0.00%)  1/35 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tacrolimus Everolimus
Affected / at Risk (%) Affected / at Risk (%)
Total   21/36 (58.33%)   24/35 (68.57%) 
Blood and lymphatic system disorders     
Anaemia  1  0/36 (0.00%)  3/35 (8.57%) 
Leukopenia  1  0/36 (0.00%)  2/35 (5.71%) 
Polycythaemia  1  1/36 (2.78%)  2/35 (5.71%) 
Gastrointestinal disorders     
Aphthous stomatitis  1  0/36 (0.00%)  3/35 (8.57%) 
Diarrhoea  1  4/36 (11.11%)  3/35 (8.57%) 
General disorders     
Asthenia  1  2/36 (5.56%)  0/35 (0.00%) 
Oedema peripheral  1  3/36 (8.33%)  6/35 (17.14%) 
Infections and infestations     
Bronchitis  1  2/36 (5.56%)  0/35 (0.00%) 
Escherichia urinary tract infection  1  4/36 (11.11%)  4/35 (11.43%) 
Nasopharyngitis  1  0/36 (0.00%)  2/35 (5.71%) 
Pneumonia  1  0/36 (0.00%)  2/35 (5.71%) 
Respiratory tract infection  1  1/36 (2.78%)  2/35 (5.71%) 
Urinary tract infection  1  7/36 (19.44%)  1/35 (2.86%) 
Urinary tract infection bacterial  1  1/36 (2.78%)  2/35 (5.71%) 
Injury, poisoning and procedural complications     
Arteriovenous fistula site complication  1  0/36 (0.00%)  2/35 (5.71%) 
Metabolism and nutrition disorders     
Dyslipidaemia  1  2/36 (5.56%)  1/35 (2.86%) 
Hypercalcaemia  1  3/36 (8.33%)  1/35 (2.86%) 
Hypercholesterolaemia  1  1/36 (2.78%)  2/35 (5.71%) 
Hyperglycaemia  1  2/36 (5.56%)  2/35 (5.71%) 
Hypertriglyceridaemia  1  0/36 (0.00%)  2/35 (5.71%) 
Musculoskeletal and connective tissue disorders     
Osteoporosis  1  2/36 (5.56%)  1/35 (2.86%) 
Tendonitis  1  2/36 (5.56%)  0/35 (0.00%) 
Nervous system disorders     
Dizziness  1  0/36 (0.00%)  2/35 (5.71%) 
Headache  1  2/36 (5.56%)  2/35 (5.71%) 
Psychiatric disorders     
Depression  1  0/36 (0.00%)  2/35 (5.71%) 
Renal and urinary disorders     
Proteinuria  1  0/36 (0.00%)  5/35 (14.29%) 
Reproductive system and breast disorders     
Metrorrhagia  1  0/36 (0.00%)  2/35 (5.71%) 
Skin and subcutaneous tissue disorders     
Acne  1  0/36 (0.00%)  2/35 (5.71%) 
Dermatitis  1  0/36 (0.00%)  2/35 (5.71%) 
Seborrhoeic dermatitis  1  2/36 (5.56%)  0/35 (0.00%) 
Vascular disorders     
Hypertension  1  1/36 (2.78%)  5/35 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights 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 the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01169701     History of Changes
Other Study ID Numbers: CRAD001AES07
2009-013780-19 ( EudraCT Number )
First Submitted: July 22, 2010
First Posted: July 26, 2010
Results First Submitted: April 10, 2015
Results First Posted: April 30, 2015
Last Update Posted: December 7, 2015