Trial Outcomes & Findings for Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients (NCT NCT00965094)

Last Updated: 2014-08-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

9 months

Results posted on

2014-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	19	17
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	5	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Everolimus n=19 Participants 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 n=17 Participants 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.	Total n=36 Participants Total of all reporting groups
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	53.1 Years STANDARD_DEVIATION 13.4 • n=5 Participants	49.6 Years STANDARD_DEVIATION 12.1 • n=7 Participants	51.4 Years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: 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).

Outcome measures

Outcome measures
Measure	Everolimus n=15 Participants 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 n=15 Participants Control Arm: 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.
Renal Function Assessed as Glomerula Filtration Rate (GFR) - Nankivell Method - 9 Months After Renal Transplantation (LOCF)	15.0 mL/min/1.73m^2 Standard Deviation 10.3	16.6 mL/min/1.73m^2 Standard Deviation 7.0

SECONDARY outcome

Timeframe: 9 months

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.

Outcome measures

Outcome measures
Measure	Everolimus n=15 Participants 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 n=15 Participants Control Arm: 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.
Assessment of GFR by the Cockcroft-Gault Method (LOCF)	72.6 mL/min Standard Deviation 18.9	72.7 mL/min Standard Deviation 20.5

SECONDARY outcome

Timeframe: 9 months

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.

Outcome measures

Outcome measures
Measure	Everolimus n=15 Participants 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 n=15 Participants Control Arm: 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.
Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death. No	14 Participants	14 Participants
Participants Who Had Occurrence of Biopsy Proven Acute Rejection, Graft Loss or Death. Yes	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 9 months

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.

Outcome measures

Outcome measures
Measure	Everolimus n=15 Participants 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 n=15 Participants Control Arm: 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.
Participants Who Had Occurrence of Treatment Failure. No	10 Participants	14 Participants
Participants Who Had Occurrence of Treatment Failure. Yes	5 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months, 5 months, 7 months, 9 months

X(slope)=(1/value of creatinine).

Outcome measures

Outcome measures
Measure	Everolimus n=15 Participants 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 n=15 Participants Control Arm: 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.
Change in Renal Function (Creatinine Slope) (PP) Month 5 N=11, 15	0.8 mg/dl per month Standard Deviation 0.2	0.7 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (ITT) Baseline 2: Month 3 N=15, 15	0.7 mg/dl per month Standard Deviation 0.1	0.7 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (ITT) Month 3 (1st week) N=15, 4	0.7 mg/dl per month Standard Deviation 0.2	0.8 mg/dl per month Standard Deviation 0.1
Change in Renal Function (Creatinine Slope) (ITT) Month 3 (2nd week) N=15, 4	0.8 mg/dl per month Standard Deviation 0.1	0.9 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (ITT) Month 3 (3rd week) N=13, 2	0.7 mg/dl per month Standard Deviation 0.1	0.9 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (ITT) Month 3 (4th week) N=12, 0*	0.8 mg/dl per month Standard Deviation 0.1	NA mg/dl per month Standard Deviation NA No participants analyzed for this time point.
Change in Renal Function (Creatinine Slope) (ITT) Month 5 N=14, 15	0.8 mg/dl per month Standard Deviation 0.2	0.7 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (ITT) Month 7 N=14, 14	0.7 mg/dl per month Standard Deviation 0.2	0.7 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (ITT) Month 9 N=11, 15	0.8 mg/dl per month Standard Deviation 0.2	0.8 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (PP) Baseline 2: Month 3 N=11, 15	0.7 mg/dl per month Standard Deviation 0.1	0.7 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (PP) Month 3 (first week) N=11, 4	0.7 mg/dl per month Standard Deviation 0.2	0.8 mg/dl per month Standard Deviation 0.1
Change in Renal Function (Creatinine Slope) (PP) Month 3 (second week) N=11, 4	0.8 mg/dl per month Standard Deviation 0.1	0.9 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (PP) Month 3 (third week) N=10, 2	0.7 mg/dl per month Standard Deviation 0.1	0.9 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (PP) Month 3 (fourth week) N=9, 0*	0.8 mg/dl per month Standard Deviation 0.1	NA mg/dl per month Standard Deviation NA No participants analyzed for this time point.
Change in Renal Function (Creatinine Slope) (PP) Month 7 N=11, 14	0.8 mg/dl per month Standard Deviation 0.2	0.7 mg/dl per month Standard Deviation 0.2
Change in Renal Function (Creatinine Slope) (PP) Month 9 N=11, 15	0.8 mg/dl per month Standard Deviation 0.2	0.8 mg/dl per month Standard Deviation 0.2

Adverse Events

Everolimus

Serious events: 7 serious events

Other events: 19 other events

Deaths: 0 deaths

Reference Therapy

Serious events: 7 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Everolimus n=19 participants at risk 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 n=17 participants at risk 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.
Gastrointestinal disorders Abdominal pain	5.3% 1/19	0.00% 0/17
Gastrointestinal disorders Diarrhoea	0.00% 0/19	5.9% 1/17
Gastrointestinal disorders Vomiting	0.00% 0/19	5.9% 1/17
General disorders Pyrexia	0.00% 0/19	5.9% 1/17
Immune system disorders Transplant rejection	10.5% 2/19	5.9% 1/17
Infections and infestations Gastroenteritis viral	5.3% 1/19	0.00% 0/17
Infections and infestations Herpes zoster	5.3% 1/19	0.00% 0/17
Infections and infestations Urinary tract infection	5.3% 1/19	5.9% 1/17
Injury, poisoning and procedural complications Hip fracture	5.3% 1/19	0.00% 0/17
Investigations Blood creatinine increased	5.3% 1/19	17.6% 3/17
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/19	5.9% 1/17
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	5.3% 1/19	0.00% 0/17
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage unspecified	5.3% 1/19	0.00% 0/17
Surgical and medical procedures Craniotomy	5.3% 1/19	0.00% 0/17
Vascular disorders Lymphocele	5.3% 1/19	0.00% 0/17

Other adverse events

Other adverse events
Measure	Everolimus n=19 participants at risk 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 n=17 participants at risk 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.
Blood and lymphatic system disorders Anaemia	15.8% 3/19	5.9% 1/17
Blood and lymphatic system disorders Leukopenia	26.3% 5/19	5.9% 1/17
Blood and lymphatic system disorders Monocytosis	5.3% 1/19	0.00% 0/17
Blood and lymphatic system disorders Neutropenia	10.5% 2/19	0.00% 0/17
Cardiac disorders Atrial fibrillation	5.3% 1/19	0.00% 0/17
Cardiac disorders Sinus tachycardia	0.00% 0/19	5.9% 1/17
Cardiac disorders Tachycardia	5.3% 1/19	0.00% 0/17
Endocrine disorders Diabetes mellitus	10.5% 2/19	17.6% 3/17
Endocrine disorders Hypercalcaemia	5.3% 1/19	0.00% 0/17
Eye disorders Orbital oedema	5.3% 1/19	0.00% 0/17
Gastrointestinal disorders Abdominal distension	0.00% 0/19	5.9% 1/17
Gastrointestinal disorders Abdominal pain	15.8% 3/19	0.00% 0/17
Gastrointestinal disorders Abdominal pain upper	0.00% 0/19	5.9% 1/17
Gastrointestinal disorders Aphthous stomatitis	26.3% 5/19	0.00% 0/17
Gastrointestinal disorders Diarrhoea	10.5% 2/19	5.9% 1/17
Gastrointestinal disorders Inguinal hernia	0.00% 0/19	5.9% 1/17
Gastrointestinal disorders Oral discomfort	5.3% 1/19	0.00% 0/17
Gastrointestinal disorders Reflux oesophagitis	5.3% 1/19	0.00% 0/17
Gastrointestinal disorders Vomiting	5.3% 1/19	0.00% 0/17
General disorders Fatigue	0.00% 0/19	5.9% 1/17
General disorders Oedema	0.00% 0/19	5.9% 1/17
General disorders Oedema peripheral	10.5% 2/19	11.8% 2/17
General disorders Pyrexia	15.8% 3/19	0.00% 0/17
Immune system disorders Transplant rejection	5.3% 1/19	0.00% 0/17
Infections and infestations Herpes zoster	5.3% 1/19	0.00% 0/17
Infections and infestations Human polyomavirus infection	15.8% 3/19	11.8% 2/17
Infections and infestations Infection	5.3% 1/19	0.00% 0/17
Infections and infestations Sinusitis	0.00% 0/19	5.9% 1/17
Infections and infestations Urinary tract infection	0.00% 0/19	11.8% 2/17
Infections and infestations Urosepsis	5.3% 1/19	0.00% 0/17
Injury, poisoning and procedural complications Abdominal wound dehiscence	5.3% 1/19	0.00% 0/17
Investigations Blood creatinine increased	10.5% 2/19	17.6% 3/17
Investigations Blood lactate dehydrogenase	21.1% 4/19	5.9% 1/17
Investigations Blood lactate dehydrogenase increased	5.3% 1/19	0.00% 0/17
Investigations Epstein-Barr virus test positive	5.3% 1/19	0.00% 0/17
Investigations Hepatic enzyme increased	0.00% 0/19	5.9% 1/17
Investigations Liver function test abnormal	0.00% 0/19	5.9% 1/17
Metabolism and nutrition disorders Hypercholesterolaemia	15.8% 3/19	0.00% 0/17
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/19	5.9% 1/17
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/19	5.9% 1/17
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/19	41.2% 7/17
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/19	5.9% 1/17
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19	5.9% 1/17
Nervous system disorders Dizziness	5.3% 1/19	0.00% 0/17
Nervous system disorders Headache	0.00% 0/19	5.9% 1/17
Nervous system disorders Paraesthesia	5.3% 1/19	0.00% 0/17
Nervous system disorders Tremor	10.5% 2/19	0.00% 0/17
Psychiatric disorders Hallucination	5.3% 1/19	0.00% 0/17
Renal and urinary disorders Bladder pain	5.3% 1/19	0.00% 0/17
Renal and urinary disorders Dysuria	0.00% 0/19	17.6% 3/17
Renal and urinary disorders Glycosuria	10.5% 2/19	0.00% 0/17
Renal and urinary disorders Haematuria	0.00% 0/19	5.9% 1/17
Renal and urinary disorders Proteinuria	31.6% 6/19	0.00% 0/17
Renal and urinary disorders Ureteric stenosis	5.3% 1/19	0.00% 0/17
Renal and urinary disorders Urinary incontinence	0.00% 0/19	11.8% 2/17
Renal and urinary disorders Vesicoureteric reflux	5.3% 1/19	0.00% 0/17
Reproductive system and breast disorders Amenorrhoea	5.3% 1/19	0.00% 0/17
Respiratory, thoracic and mediastinal disorders Cough	5.3% 1/19	5.9% 1/17
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.5% 2/19	0.00% 0/17
Skin and subcutaneous tissue disorders Acne	10.5% 2/19	0.00% 0/17
Skin and subcutaneous tissue disorders Blister	0.00% 0/19	5.9% 1/17
Skin and subcutaneous tissue disorders Pruritus	5.3% 1/19	0.00% 0/17
Surgical and medical procedures Bladder anastomosis	0.00% 0/19	5.9% 1/17
Surgical and medical procedures Urethral repair	5.3% 1/19	0.00% 0/17
Vascular disorders Hypertension	0.00% 0/19	5.9% 1/17

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER