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Trial Outcomes & Findings for Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients (NCT NCT00369278)

NCT ID: NCT00369278

Last Updated: 2011-03-29

Results Overview

Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

128 participants

Primary outcome timeframe

Assessed on day 3, 10, 21, 42, 56 and 84

Results posted on

2011-03-29

Participant Flow

Participant milestones

Participant milestones
Measure
Intensified Mycophenolate Sodium
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
Overall Study
STARTED
63
65
Overall Study
COMPLETED
39
44
Overall Study
NOT COMPLETED
24
21

Reasons for withdrawal

Reasons for withdrawal
Measure
Intensified Mycophenolate Sodium
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
Overall Study
Adverse Event
14
11
Overall Study
Unsatisfactory therapeutic effect
4
5
Overall Study
Protocol Violation
2
1
Overall Study
Withdrawal by Subject
2
2
Overall Study
Lost to Follow-up
1
0
Overall Study
Graft loss
1
2

Baseline Characteristics

Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intensified Mycophenolate Sodium
n=63 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
n=65 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
Total
n=128 Participants
Total of all reporting groups
Age Continuous
52.4 years
STANDARD_DEVIATION 12.5 • n=5 Participants
50.4 years
STANDARD_DEVIATION 14.6 • n=7 Participants
51.4 years
STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male
Female
29 Participants
n=5 Participants
30 Participants
n=7 Participants
59 Participants
n=5 Participants
Sex: Female, Male
Male
34 Participants
n=5 Participants
35 Participants
n=7 Participants
69 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Assessed on day 3, 10, 21, 42, 56 and 84

Population: Pharmacokinetic profiles were performed only in patients involved in Phase I of the study. The pharmacokinetic population consisted of 42 participants.

Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.

Outcome measures

Outcome measures
Measure
Intensified Mycophenolate Sodium
n=23 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
n=19 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L
7.00 Days
Interval 5.0 to 23.0
43.00 Days
Interval 12.0 to 58.0

PRIMARY outcome

Timeframe: 6 months

Median time to first occurrence of treatment failure was not reached in this study.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.

Outcome measures

Outcome measures
Measure
Intensified Mycophenolate Sodium
n=63 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
n=65 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
Number of Participants With Any Treatment Failure
19 Participants
24 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Intent-to-treat population

Rates for all individual components of the primary endpoint 'treatment failure' until day 180: * Acute rejection diagnosed by biopsy (BPAR) * graft loss * death * loss to follow up * discontinuation from study drug due to lack of efficacy or toxicity (adverse events, every adverse event had to be interpreted as toxicity) * conversion to another dosing regimen (conversion to tacrolimus, prograf, etc.)

Outcome measures

Outcome measures
Measure
Intensified Mycophenolate Sodium
n=63 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
n=65 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
Number of Participants With Single Treatment Failures
Biopsy-proven acute rejection
2 Participants
11 Participants
Number of Participants With Single Treatment Failures
Graft loss
1 Participants
2 Participants
Number of Participants With Single Treatment Failures
Death
0 Participants
0 Participants
Number of Participants With Single Treatment Failures
Loss to follow-up
1 Participants
0 Participants
Number of Participants With Single Treatment Failures
Discontinuation due to lack of efficacy / toxicity
17 Participants
15 Participants
Number of Participants With Single Treatment Failures
Conversion of doses
8 Participants
10 Participants
Number of Participants With Single Treatment Failures
Treated rejections
13 Participants
24 Participants

SECONDARY outcome

Timeframe: 6 months

Due to a small number of events, median time to \<event\> was not reached.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Due to a small number of events, median time to \<event\> was not reached.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure
Intensified Mycophenolate Sodium
n=63 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
n=65 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
Renal Function as Measured by Serum Creatinine
End of study
2.2 mg/dL
Standard Deviation 1.5
2.6 mg/dL
Standard Deviation 2.2
Renal Function as Measured by Serum Creatinine
Baseline
8.0 mg/dL
Standard Deviation 2.7
7.8 mg/dL
Standard Deviation 2.9

SECONDARY outcome

Timeframe: 6 months

Population: Intent-to-treat population for whom data was available. End of Study data was imputed using Last Observation Carried Forward (LOCF).

The Glomerular Filtration Rate (GFR) was calculated using the following formulas: * Cockcroft-Gault formula: calculation using the participant's age, gender, weight, and serum creatinine levels. * MDRD formula: calculation using the participant's age, gender, serum creatinine, urea nitrogen, and albumin levels.

Outcome measures

Outcome measures
Measure
Intensified Mycophenolate Sodium
n=63 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
n=65 Participants
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
Renal Function as Measured by Glomerular Filtration Rate (GFR)
MDRD formula: Baseline [n=44, 56]
9.0 ml/min
Standard Deviation 3.9
9.4 ml/min
Standard Deviation 3.9
Renal Function as Measured by Glomerular Filtration Rate (GFR)
MDRD formula: End of study [n=61, 64]
41.1 ml/min
Standard Deviation 17.1
40.6 ml/min
Standard Deviation 24.8
Renal Function as Measured by Glomerular Filtration Rate (GFR)
Cockcroft-Gault formula: Baseline [n=61, 65]
12.1 ml/min
Standard Deviation 4.8
12.0 ml/min
Standard Deviation 5.0
Renal Function as Measured by Glomerular Filtration Rate (GFR)
Cockcroft-Gault formula: End of study [n=63, 65]
52.4 ml/min
Standard Deviation 23.9
47.9 ml/min
Standard Deviation 27.1

Adverse Events

Intensified Mycophenolate Sodium

Serious events: 44 serious events
Other events: 62 other events
Deaths: 0 deaths

Standard Mycophenolate Sodium

Serious events: 40 serious events
Other events: 63 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Intensified Mycophenolate Sodium
n=63 participants at risk
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
n=65 participants at risk
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study (month 6): 1440 mg/day (2 x 720 mg)
Blood and lymphatic system disorders
Anaemia
3.2%
2/63
0.00%
0/65
Blood and lymphatic system disorders
Disseminated intravascular coagulation
1.6%
1/63
0.00%
0/65
Blood and lymphatic system disorders
Leukopenia
1.6%
1/63
1.5%
1/65
Cardiac disorders
Myocardial infarction
1.6%
1/63
0.00%
0/65
Cardiac disorders
Supraventricular tachycardia
0.00%
0/63
1.5%
1/65
Cardiac disorders
Tricuspid valve incompetence
0.00%
0/63
1.5%
1/65
Cardiac disorders
Wolff-Parkinson-White syndrome
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Abdominal pain
3.2%
2/63
0.00%
0/65
Gastrointestinal disorders
Diarrhoea
6.3%
4/63
1.5%
1/65
Gastrointestinal disorders
Duodenal ulcer
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Duodenitis
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Gastritis
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Ileus
0.00%
0/63
3.1%
2/65
Gastrointestinal disorders
Inguinal hernia
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Inguinal hernia, obstructive
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Intra-abdominal haematoma
1.6%
1/63
0.00%
0/65
Gastrointestinal disorders
Intra-abdominal haemorrhage
1.6%
1/63
0.00%
0/65
Gastrointestinal disorders
Large intestine perforation
1.6%
1/63
0.00%
0/65
Gastrointestinal disorders
Nausea
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Pancreatitis acute
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Reflux oesophagitis
0.00%
0/63
1.5%
1/65
Gastrointestinal disorders
Small intestinal perforation
1.6%
1/63
0.00%
0/65
Gastrointestinal disorders
Vomiting
1.6%
1/63
1.5%
1/65
General disorders
Catheter related complication
0.00%
0/63
1.5%
1/65
General disorders
Impaired healing
1.6%
1/63
0.00%
0/65
General disorders
Multi-organ failure
0.00%
0/63
1.5%
1/65
General disorders
Oedema peripheral
1.6%
1/63
0.00%
0/65
General disorders
Pyrexia
1.6%
1/63
0.00%
0/65
Immune system disorders
Transplant rejection
0.00%
0/63
3.1%
2/65
Infections and infestations
Abdominal abscess
1.6%
1/63
0.00%
0/65
Infections and infestations
Clostridium difficile colitis
0.00%
0/63
1.5%
1/65
Infections and infestations
Cytomegalovirus gastritis
1.6%
1/63
0.00%
0/65
Infections and infestations
Cytomegalovirus infection
3.2%
2/63
1.5%
1/65
Infections and infestations
Enterococcal infection
1.6%
1/63
1.5%
1/65
Infections and infestations
Escherichia bacteraemia
1.6%
1/63
0.00%
0/65
Infections and infestations
Gastroenteritis
1.6%
1/63
0.00%
0/65
Infections and infestations
Gastroenteritis clostridial
1.6%
1/63
0.00%
0/65
Infections and infestations
Gastroenteritis norovirus
3.2%
2/63
1.5%
1/65
Infections and infestations
Gastrointestinal infection
0.00%
0/63
1.5%
1/65
Infections and infestations
Haematoma infection
1.6%
1/63
0.00%
0/65
Infections and infestations
Human polyomavirus infection
1.6%
1/63
1.5%
1/65
Infections and infestations
Infected lymphocele
0.00%
0/63
3.1%
2/65
Infections and infestations
Infection
3.2%
2/63
1.5%
1/65
Infections and infestations
Oesophageal candidiasis
0.00%
0/63
1.5%
1/65
Infections and infestations
Otitis media
1.6%
1/63
0.00%
0/65
Infections and infestations
Perinephric abscess
1.6%
1/63
0.00%
0/65
Infections and infestations
Pneumonia
6.3%
4/63
0.00%
0/65
Infections and infestations
Renal abscess
0.00%
0/63
1.5%
1/65
Infections and infestations
Renal cyst infection
0.00%
0/63
1.5%
1/65
Infections and infestations
Respiratory tract infection
0.00%
0/63
1.5%
1/65
Infections and infestations
Sepsis
0.00%
0/63
1.5%
1/65
Infections and infestations
Staphylococcal infection
1.6%
1/63
0.00%
0/65
Infections and infestations
Tracheobronchitis
1.6%
1/63
0.00%
0/65
Infections and infestations
Upper respiratory tract infection
1.6%
1/63
0.00%
0/65
Infections and infestations
Urinary tract infection
7.9%
5/63
13.8%
9/65
Infections and infestations
Urosepsis
1.6%
1/63
6.2%
4/65
Infections and infestations
Wound abscess
1.6%
1/63
0.00%
0/65
Infections and infestations
Wound infection
3.2%
2/63
0.00%
0/65
Infections and infestations
Wound infection bacterial
1.6%
1/63
0.00%
0/65
Infections and infestations
Wound infection staphylococcal
1.6%
1/63
0.00%
0/65
Injury, poisoning and procedural complications
Anastomotic leak
1.6%
1/63
0.00%
0/65
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
3.2%
2/63
0.00%
0/65
Injury, poisoning and procedural complications
Clavicle fracture
0.00%
0/63
1.5%
1/65
Injury, poisoning and procedural complications
Complications of transplanted kidney
3.2%
2/63
4.6%
3/65
Injury, poisoning and procedural complications
Femoral neck fracture
0.00%
0/63
1.5%
1/65
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/63
1.5%
1/65
Injury, poisoning and procedural complications
Graft loss
3.2%
2/63
3.1%
2/65
Injury, poisoning and procedural complications
Incisional hernia
1.6%
1/63
1.5%
1/65
Injury, poisoning and procedural complications
Perirenal haematoma
0.00%
0/63
3.1%
2/65
Injury, poisoning and procedural complications
Post procedural urine leak
3.2%
2/63
1.5%
1/65
Injury, poisoning and procedural complications
Seroma
0.00%
0/63
1.5%
1/65
Injury, poisoning and procedural complications
Shunt aneurysm
1.6%
1/63
0.00%
0/65
Injury, poisoning and procedural complications
Thoracic vertebral fracture
1.6%
1/63
0.00%
0/65
Injury, poisoning and procedural complications
Transplant failure
0.00%
0/63
7.7%
5/65
Injury, poisoning and procedural complications
Wound dehiscence
1.6%
1/63
1.5%
1/65
Investigations
Blood creatinine increased
14.3%
9/63
9.2%
6/65
Investigations
Haemoglobin decreased
0.00%
0/63
1.5%
1/65
Metabolism and nutrition disorders
Calciphylaxis
0.00%
0/63
1.5%
1/65
Metabolism and nutrition disorders
Dehydration
1.6%
1/63
0.00%
0/65
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/63
1.5%
1/65
Metabolism and nutrition disorders
Hypervolaemia
0.00%
0/63
1.5%
1/65
Nervous system disorders
Cerebral infarction
0.00%
0/63
1.5%
1/65
Nervous system disorders
Cerebrovascular accident
0.00%
0/63
1.5%
1/65
Nervous system disorders
Migraine
0.00%
0/63
1.5%
1/65
Nervous system disorders
Transient ischaemic attack
1.6%
1/63
1.5%
1/65
Nervous system disorders
Uraemic encephalopathy
0.00%
0/63
1.5%
1/65
Psychiatric disorders
Delirium
0.00%
0/63
1.5%
1/65
Psychiatric disorders
Depression
1.6%
1/63
0.00%
0/65
Psychiatric disorders
Hallucination, visual
1.6%
1/63
0.00%
0/65
Renal and urinary disorders
Haematuria
0.00%
0/63
1.5%
1/65
Renal and urinary disorders
Renal artery occlusion
1.6%
1/63
0.00%
0/65
Renal and urinary disorders
Renal artery stenosis
3.2%
2/63
0.00%
0/65
Renal and urinary disorders
Renal failure
1.6%
1/63
0.00%
0/65
Renal and urinary disorders
Renal failure acute
6.3%
4/63
7.7%
5/65
Renal and urinary disorders
Ureteral necrosis
0.00%
0/63
1.5%
1/65
Renal and urinary disorders
Urinary retention
3.2%
2/63
1.5%
1/65
Renal and urinary disorders
Urinary tract obstruction
1.6%
1/63
1.5%
1/65
Renal and urinary disorders
Urinoma
1.6%
1/63
3.1%
2/65
Renal and urinary disorders
Vesicoureteric reflux
1.6%
1/63
0.00%
0/65
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.00%
0/63
1.5%
1/65
Reproductive system and breast disorders
Pelvic congestion
3.2%
2/63
3.1%
2/65
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/63
1.5%
1/65
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/63
1.5%
1/65
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/63
1.5%
1/65
Respiratory, thoracic and mediastinal disorders
Pneumothorax
1.6%
1/63
0.00%
0/65
Skin and subcutaneous tissue disorders
Skin inflammation
1.6%
1/63
0.00%
0/65
Surgical and medical procedures
Pneumatic compression therapy
0.00%
0/63
1.5%
1/65
Surgical and medical procedures
Wound treatment
1.6%
1/63
0.00%
0/65
Vascular disorders
Deep vein thrombosis
0.00%
0/63
3.1%
2/65
Vascular disorders
Femoral arterial stenosis
1.6%
1/63
0.00%
0/65
Vascular disorders
Haematoma
1.6%
1/63
0.00%
0/65
Vascular disorders
Hypertension
3.2%
2/63
1.5%
1/65
Vascular disorders
Lymphocele
6.3%
4/63
4.6%
3/65
Vascular disorders
Peripheral artery aneurysm
1.6%
1/63
0.00%
0/65
Vascular disorders
Peripheral artery dissection
1.6%
1/63
0.00%
0/65
Vascular disorders
Shock
0.00%
0/63
1.5%
1/65
Vascular disorders
Shock haemorrhagic
1.6%
1/63
0.00%
0/65

Other adverse events

Other adverse events
Measure
Intensified Mycophenolate Sodium
n=63 participants at risk
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
Standard Mycophenolate Sodium
n=65 participants at risk
Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study (month 6): 1440 mg/day (2 x 720 mg)
Blood and lymphatic system disorders
Anaemia
25.4%
16/63
29.2%
19/65
Blood and lymphatic system disorders
Leukopenia
19.0%
12/63
21.5%
14/65
Blood and lymphatic system disorders
Thrombocytopenia
6.3%
4/63
1.5%
1/65
Gastrointestinal disorders
Abdominal pain
17.5%
11/63
7.7%
5/65
Gastrointestinal disorders
Constipation
30.2%
19/63
23.1%
15/65
Gastrointestinal disorders
Diarrhoea
30.2%
19/63
35.4%
23/65
Gastrointestinal disorders
Dyspepsia
6.3%
4/63
0.00%
0/65
Gastrointestinal disorders
Flatulence
20.6%
13/63
10.8%
7/65
Gastrointestinal disorders
Nausea
36.5%
23/63
29.2%
19/65
Gastrointestinal disorders
Vomiting
25.4%
16/63
24.6%
16/65
General disorders
Oedema
25.4%
16/63
21.5%
14/65
General disorders
Oedema peripheral
23.8%
15/63
24.6%
16/65
General disorders
Pain
1.6%
1/63
6.2%
4/65
General disorders
Pyrexia
4.8%
3/63
12.3%
8/65
Infections and infestations
BK virus infection
6.3%
4/63
1.5%
1/65
Infections and infestations
Cytomegalovirus infection
3.2%
2/63
10.8%
7/65
Infections and infestations
Nasopharyngitis
4.8%
3/63
12.3%
8/65
Infections and infestations
Pneumonia
1.6%
1/63
10.8%
7/65
Infections and infestations
Rhinitis
6.3%
4/63
7.7%
5/65
Infections and infestations
Urinary tract infection
38.1%
24/63
40.0%
26/65
Injury, poisoning and procedural complications
Complications of transplanted kidney
31.7%
20/63
33.8%
22/65
Injury, poisoning and procedural complications
Procedural pain
4.8%
3/63
6.2%
4/65
Injury, poisoning and procedural complications
Wound complication
14.3%
9/63
20.0%
13/65
Injury, poisoning and procedural complications
Wound dehiscence
11.1%
7/63
13.8%
9/65
Investigations
Blood creatinine increased
11.1%
7/63
18.5%
12/65
Investigations
Blood glucose increased
7.9%
5/63
3.1%
2/65
Investigations
C-reactive protein increased
11.1%
7/63
1.5%
1/65
Investigations
Haemoglobin decreased
6.3%
4/63
1.5%
1/65
Investigations
Weight increased
6.3%
4/63
1.5%
1/65
Metabolism and nutrition disorders
Diabetes mellitus
7.9%
5/63
9.2%
6/65
Metabolism and nutrition disorders
Hypercholesterolaemia
11.1%
7/63
9.2%
6/65
Metabolism and nutrition disorders
Hyperkalaemia
14.3%
9/63
13.8%
9/65
Metabolism and nutrition disorders
Hyperphosphataemia
6.3%
4/63
9.2%
6/65
Metabolism and nutrition disorders
Hyperuricaemia
6.3%
4/63
7.7%
5/65
Metabolism and nutrition disorders
Hypocalcaemia
30.2%
19/63
21.5%
14/65
Metabolism and nutrition disorders
Hypokalaemia
36.5%
23/63
47.7%
31/65
Metabolism and nutrition disorders
Hypomagnesaemia
9.5%
6/63
7.7%
5/65
Metabolism and nutrition disorders
Hypophosphataemia
20.6%
13/63
15.4%
10/65
Musculoskeletal and connective tissue disorders
Back pain
3.2%
2/63
7.7%
5/65
Musculoskeletal and connective tissue disorders
Muscle spasms
11.1%
7/63
1.5%
1/65
Musculoskeletal and connective tissue disorders
Pain in extremity
4.8%
3/63
7.7%
5/65
Nervous system disorders
Headache
12.7%
8/63
13.8%
9/65
Nervous system disorders
Tremor
6.3%
4/63
4.6%
3/65
Psychiatric disorders
Sleep disorder
17.5%
11/63
18.5%
12/65
Renal and urinary disorders
Bladder pain
9.5%
6/63
13.8%
9/65
Renal and urinary disorders
Dysuria
9.5%
6/63
4.6%
3/65
Renal and urinary disorders
Haematuria
11.1%
7/63
7.7%
5/65
Renal and urinary disorders
Residual urine
6.3%
4/63
1.5%
1/65
Renal and urinary disorders
Urinary retention
9.5%
6/63
3.1%
2/65
Renal and urinary disorders
Urinary tract obstruction
1.6%
1/63
10.8%
7/65
Respiratory, thoracic and mediastinal disorders
Cough
11.1%
7/63
10.8%
7/65
Respiratory, thoracic and mediastinal disorders
Dyspnoea
7.9%
5/63
12.3%
8/65
Vascular disorders
Haematoma
0.00%
0/63
7.7%
5/65
Vascular disorders
Hypertension
15.9%
10/63
6.2%
4/65
Vascular disorders
Hypotension
12.7%
8/63
4.6%
3/65
Vascular disorders
Lymphocele
6.3%
4/63
21.5%
14/65

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