Trial Outcomes & Findings for Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients (NCT NCT00154284)
NCT ID: NCT00154284
Last Updated: 2018-08-09
Results Overview
Nankivell's formula for calculated GFR is shown below: GFR \[mL/min\] = 6.7/C + W/4 - UREA/2 - 100/H2+ 35 (25 for females). Where W is body weight at specific visit \[kg\], H is height at specific visit \[m\], C is the serum concentration of creatinine \[mmol/L\], and UREA is the serum concentration of urea \[mmol/L\]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441\*BUN. If a GFR value from Nankivell formula was less than 10 \[mL/min\], then the value was assigned as 10 \[mL/min\].
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
114 participants
Primary outcome timeframe
At Month 3 and Month 12
Results posted on
2018-08-09
Participant Flow
Subjects were recruited from Spain from July 2005 to July 2008. As per protocol amendment, data were analyzed together with data from study CRAD001A2423 (NCT00154284) and CRAD001A2423 (NCT00170807).
Participant milestones
| Measure |
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
55
|
|
Overall Study
Intent to Treat (ITT) Population
|
57
|
53
|
|
Overall Study
COMPLETED
|
52
|
42
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
Reasons for withdrawal
| Measure |
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
9
|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
n=59 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
n=55 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 12.27 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 12.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 3 and Month 12Population: Intention to treat (ITT) population.
Nankivell's formula for calculated GFR is shown below: GFR \[mL/min\] = 6.7/C + W/4 - UREA/2 - 100/H2+ 35 (25 for females). Where W is body weight at specific visit \[kg\], H is height at specific visit \[m\], C is the serum concentration of creatinine \[mmol/L\], and UREA is the serum concentration of urea \[mmol/L\]. UREA was calculated from blood urea nitrogen (BUN) lab data by: UREA = 2.1441\*BUN. If a GFR value from Nankivell formula was less than 10 \[mL/min\], then the value was assigned as 10 \[mL/min\].
Outcome measures
| Measure |
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
n=57 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
n=53 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)
GFR at 3 months (Pre-randomization)
|
68.5 mL/min per 1.73 m^2
Standard Deviation 19.92
|
69.2 mL/min per 1.73 m^2
Standard Deviation 18.40
|
|
Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)
GFR at 12 months
|
63.6 mL/min per 1.73 m^2
Standard Deviation 14.61
|
68.3 mL/min per 1.73 m^2
Standard Deviation 15.13
|
SECONDARY outcome
Timeframe: Month 12Population: Intention to treat (ITT) population.
Renal biopsies were collected for all cases of suspected acute rejection. For these cases, regardless of initiation of anti-rejection treatment, a graft core biopsy had been performed within 48 hours. These biopsies were listed on the Kidney Allograft Biopsy eCRF and the results used for patient management for BPAR. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant. BPAR, graft loss, death, or loss to follow-up was analyzed by means of frequency tables.
Outcome measures
| Measure |
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
n=57 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
n=53 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
Biopsy-proven Acute Rejection (BPAR)
|
10 Participants
|
10 Participants
|
|
Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
Graft Loss
|
0 Participants
|
0 Participants
|
|
Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
Death
|
0 Participants
|
0 Participants
|
|
Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-up
Loss to Follow-up
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 month and 12 monthsPopulation: Intention to treat (ITT) population.
serum creatinine summarized by mean and standard deviation
Outcome measures
| Measure |
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
n=53 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
n=57 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Serum Creatinine at Month 6 and 12
6 Month
|
120.1 µmol/L
Standard Deviation 31.22
|
139.1 µmol/L
Standard Deviation 47.03
|
|
Serum Creatinine at Month 6 and 12
12 Month
|
123.0 µmol/L
Standard Deviation 40.28
|
135.6 µmol/L
Standard Deviation 40.61
|
SECONDARY outcome
Timeframe: 6 month and 12 monthsPopulation: Intention to treat (ITT) population.
Creatinine clearance calculated by Cockcroft-Gault formula and summarized by mean, and standard deviation. Cockcroft-Gault formula to calculate Creatinine Clearance (CrCl\[mL/min\]) is shown below: CrCl\[mL/min\] = (140 - A) \* W / (72 \* C) \* R. Where A is age at sample date \[years\], W is body weight at specific visit \[kg\], C is the serum concentration of creatinine \[mg/dL\], R = 1 if the patient is male and = 0.85 if female.
Outcome measures
| Measure |
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
n=53 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
n=57 Participants
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Calculated Creatinine Clearance at 6 Month and 12 Month
6 Month
|
72.9 mL/min
Standard Deviation 19.34
|
63.6 mL/min
Standard Deviation 19.65
|
|
Calculated Creatinine Clearance at 6 Month and 12 Month
12 Month
|
72.3 mL/min
Standard Deviation 20.50
|
65.6 mL/min
Standard Deviation 19.24
|
Adverse Events
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
Serious events: 16 serious events
Other events: 38 other events
Deaths: 0 deaths
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
Serious events: 14 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
n=55 participants at risk
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
n=59 participants at risk
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/55
|
1.7%
1/59
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/55
|
1.7%
1/59
|
|
Gastrointestinal disorders
Stomatitis
|
1.8%
1/55
|
0.00%
0/59
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55
|
0.00%
0/59
|
|
General disorders
Pyrexia
|
1.8%
1/55
|
1.7%
1/59
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/55
|
3.4%
2/59
|
|
Infections and infestations
Abdominal wall infection
|
1.8%
1/55
|
0.00%
0/59
|
|
Infections and infestations
Anal abscess
|
1.8%
1/55
|
0.00%
0/59
|
|
Infections and infestations
Appendiceal abscess
|
1.8%
1/55
|
0.00%
0/59
|
|
Infections and infestations
Appendicitis
|
1.8%
1/55
|
0.00%
0/59
|
|
Infections and infestations
Bronchitis
|
0.00%
0/55
|
1.7%
1/59
|
|
Infections and infestations
Enterocolitis infectious
|
1.8%
1/55
|
0.00%
0/59
|
|
Infections and infestations
Febrile infection
|
0.00%
0/55
|
1.7%
1/59
|
|
Infections and infestations
Gastroenteritis
|
3.6%
2/55
|
3.4%
2/59
|
|
Infections and infestations
Pneumonia
|
1.8%
1/55
|
1.7%
1/59
|
|
Infections and infestations
Pneumonia bacterial
|
1.8%
1/55
|
0.00%
0/59
|
|
Infections and infestations
Renal cyst infection
|
0.00%
0/55
|
1.7%
1/59
|
|
Infections and infestations
Sepsis
|
1.8%
1/55
|
3.4%
2/59
|
|
Infections and infestations
Soft tissue infection
|
1.8%
1/55
|
0.00%
0/59
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/55
|
5.1%
3/59
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
1.8%
1/55
|
1.7%
1/59
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.8%
1/55
|
0.00%
0/59
|
|
Injury, poisoning and procedural complications
Renal lymphocele
|
0.00%
0/55
|
1.7%
1/59
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.8%
1/55
|
0.00%
0/59
|
|
Investigations
Blood creatinine increased
|
1.8%
1/55
|
0.00%
0/59
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.8%
1/55
|
0.00%
0/59
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.8%
1/55
|
0.00%
0/59
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/55
|
1.7%
1/59
|
|
Renal and urinary disorders
Haematuria
|
1.8%
1/55
|
0.00%
0/59
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/55
|
1.7%
1/59
|
|
Renal and urinary disorders
Renal failure acute
|
5.5%
3/55
|
0.00%
0/59
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/55
|
3.4%
2/59
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
1.8%
1/55
|
0.00%
0/59
|
|
Vascular disorders
Haemorrhage
|
1.8%
1/55
|
0.00%
0/59
|
|
Vascular disorders
Lymphocele
|
1.8%
1/55
|
3.4%
2/59
|
Other adverse events
| Measure |
Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal
n=55 participants at risk
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
Everolimus (Certican) With Cyclosporine (Neoral) Continuation
n=59 participants at risk
Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
5/55
|
13.6%
8/59
|
|
Blood and lymphatic system disorders
Polycythaemia
|
5.5%
3/55
|
1.7%
1/59
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
3/55
|
8.5%
5/59
|
|
General disorders
Oedema
|
10.9%
6/55
|
6.8%
4/59
|
|
General disorders
Oedema peripheral
|
10.9%
6/55
|
6.8%
4/59
|
|
General disorders
Pyrexia
|
7.3%
4/55
|
8.5%
5/59
|
|
Infections and infestations
Bronchitis
|
1.8%
1/55
|
5.1%
3/59
|
|
Infections and infestations
Gastroenteritis
|
5.5%
3/55
|
0.00%
0/59
|
|
Infections and infestations
Nasopharyngitis
|
12.7%
7/55
|
1.7%
1/59
|
|
Infections and infestations
Urinary tract infection
|
9.1%
5/55
|
15.3%
9/59
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
7.3%
4/55
|
3.4%
2/59
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
3.6%
2/55
|
10.2%
6/59
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.6%
2/55
|
5.1%
3/59
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/55
|
5.1%
3/59
|
|
Renal and urinary disorders
Proteinuria
|
7.3%
4/55
|
1.7%
1/59
|
|
Renal and urinary disorders
Renal impairment
|
7.3%
4/55
|
6.8%
4/59
|
|
Skin and subcutaneous tissue disorders
Acne
|
7.3%
4/55
|
0.00%
0/59
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER