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

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ClinicalTrials.gov Identifier: NCT00369278
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : January 12, 2011
Last Update Posted : March 29, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Transplantation
Intervention Drug: Enteric-coated mycophenolate sodium (EC-MPS)
Enrollment 128
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Hide Arm/Group Description 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) 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)
Period Title: Overall Study
Started 63 65
Completed 39 44
Not Completed 24 21
Reason Not Completed
Adverse Event             14             11
Unsatisfactory therapeutic effect             4             5
Protocol Violation             2             1
Withdrawal by Subject             2             2
Lost to Follow-up             1             0
Graft loss             1             2
Arm/Group Title Intensified Mycophenolate Sodium Standard Mycophenolate Sodium Total
Hide Arm/Group Description 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) 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 of all reporting groups
Overall Number of Baseline Participants 63 65 128
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 65 participants 128 participants
52.4  (12.5) 50.4  (14.6) 51.4  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 65 participants 128 participants
Female
29
  46.0%
30
  46.2%
59
  46.1%
Male
34
  54.0%
35
  53.8%
69
  53.9%
1.Primary Outcome
Title Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L
Hide Description 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.
Time Frame Assessed on day 3, 10, 21, 42, 56 and 84
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic profiles were performed only in patients involved in Phase I of the study. The pharmacokinetic population consisted of 42 participants.
Arm/Group Title Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Hide Arm/Group Description:
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)
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 Number of Participants Analyzed 23 19
Median (95% Confidence Interval)
Unit of Measure: Days
7.00
(5.0 to 23.0)
43.00
(12.0 to 58.0)
2.Primary Outcome
Title Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment
Hide Description Median time to first occurrence of treatment failure was not reached in this study.
Time Frame 6 months
Outcome Measure Data Not Reported
3.Primary Outcome
Title Number of Participants With Any Treatment Failure
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Hide Arm/Group Description:
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)
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 Number of Participants Analyzed 63 65
Measure Type: Number
Unit of Measure: Participants
19 24
4.Secondary Outcome
Title Number of Participants With Single Treatment Failures
Hide Description

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.)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Hide Arm/Group Description:
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)
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 Number of Participants Analyzed 63 65
Measure Type: Number
Unit of Measure: Participants
Biopsy-proven acute rejection 2 11
Graft loss 1 2
Death 0 0
Loss to follow-up 1 0
Discontinuation due to lack of efficacy / toxicity 17 15
Conversion of doses 8 10
Treated rejections 13 24
5.Secondary Outcome
Title Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180
Hide Description Due to a small number of events, median time to <event> was not reached.
Time Frame 6 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Time to “Event” for the Composite Endpoint as Well as All Individual Components of That Endpoint “Treatment Failure” Including Clinical Rejections
Hide Description Due to a small number of events, median time to <event> was not reached.
Time Frame 6 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Renal Function as Measured by Serum Creatinine
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Hide Arm/Group Description:
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)
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 Number of Participants Analyzed 63 65
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 8.0  (2.7) 7.8  (2.9)
End of study 2.2  (1.5) 2.6  (2.2)
8.Secondary Outcome
Title Renal Function as Measured by Glomerular Filtration Rate (GFR)
Hide Description

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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population for whom data was available. End of Study data was imputed using Last Observation Carried Forward (LOCF).
Arm/Group Title Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Hide Arm/Group Description:
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)
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 Number of Participants Analyzed 63 65
Mean (Standard Deviation)
Unit of Measure: ml/min
MDRD formula: Baseline [n=44, 56] 9.0  (3.9) 9.4  (3.9)
MDRD formula: End of study [n=61, 64] 41.1  (17.1) 40.6  (24.8)
Cockcroft-Gault formula: Baseline [n=61, 65] 12.1  (4.8) 12.0  (5.0)
Cockcroft-Gault formula: End of study [n=63, 65] 52.4  (23.9) 47.9  (27.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Hide Arm/Group Description 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) 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)
All-Cause Mortality
Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   44/63 (69.84%)   40/65 (61.54%) 
Blood and lymphatic system disorders     
Anaemia  1  2/63 (3.17%)  0/65 (0.00%) 
Disseminated intravascular coagulation  1  1/63 (1.59%)  0/65 (0.00%) 
Leukopenia  1  1/63 (1.59%)  1/65 (1.54%) 
Cardiac disorders     
Myocardial infarction  1  1/63 (1.59%)  0/65 (0.00%) 
Supraventricular tachycardia  1  0/63 (0.00%)  1/65 (1.54%) 
Tricuspid valve incompetence  1  0/63 (0.00%)  1/65 (1.54%) 
Wolff-Parkinson-White syndrome  1  0/63 (0.00%)  1/65 (1.54%) 
Gastrointestinal disorders     
Abdominal pain  1  2/63 (3.17%)  0/65 (0.00%) 
Diarrhoea  1  4/63 (6.35%)  1/65 (1.54%) 
Duodenal ulcer  1  0/63 (0.00%)  1/65 (1.54%) 
Duodenitis  1  0/63 (0.00%)  1/65 (1.54%) 
Gastritis  1  0/63 (0.00%)  1/65 (1.54%) 
Gastrointestinal haemorrhage  1  0/63 (0.00%)  1/65 (1.54%) 
Ileus  1  0/63 (0.00%)  2/65 (3.08%) 
Inguinal hernia  1  0/63 (0.00%)  1/65 (1.54%) 
Inguinal hernia, obstructive  1  0/63 (0.00%)  1/65 (1.54%) 
Intra-abdominal haematoma  1  1/63 (1.59%)  0/65 (0.00%) 
Intra-abdominal haemorrhage  1  1/63 (1.59%)  0/65 (0.00%) 
Large intestine perforation  1  1/63 (1.59%)  0/65 (0.00%) 
Nausea  1  0/63 (0.00%)  1/65 (1.54%) 
Pancreatitis acute  1  0/63 (0.00%)  1/65 (1.54%) 
Reflux oesophagitis  1  0/63 (0.00%)  1/65 (1.54%) 
Small intestinal perforation  1  1/63 (1.59%)  0/65 (0.00%) 
Vomiting  1  1/63 (1.59%)  1/65 (1.54%) 
General disorders     
Catheter related complication  1  0/63 (0.00%)  1/65 (1.54%) 
Impaired healing  1  1/63 (1.59%)  0/65 (0.00%) 
Multi-organ failure  1  0/63 (0.00%)  1/65 (1.54%) 
Oedema peripheral  1  1/63 (1.59%)  0/65 (0.00%) 
Pyrexia  1  1/63 (1.59%)  0/65 (0.00%) 
Immune system disorders     
Transplant rejection  1  0/63 (0.00%)  2/65 (3.08%) 
Infections and infestations     
Abdominal abscess  1  1/63 (1.59%)  0/65 (0.00%) 
Clostridium difficile colitis  1  0/63 (0.00%)  1/65 (1.54%) 
Cytomegalovirus gastritis  1  1/63 (1.59%)  0/65 (0.00%) 
Cytomegalovirus infection  1  2/63 (3.17%)  1/65 (1.54%) 
Enterococcal infection  1  1/63 (1.59%)  1/65 (1.54%) 
Escherichia bacteraemia  1  1/63 (1.59%)  0/65 (0.00%) 
Gastroenteritis  1  1/63 (1.59%)  0/65 (0.00%) 
Gastroenteritis clostridial  1  1/63 (1.59%)  0/65 (0.00%) 
Gastroenteritis norovirus  1  2/63 (3.17%)  1/65 (1.54%) 
Gastrointestinal infection  1  0/63 (0.00%)  1/65 (1.54%) 
Haematoma infection  1  1/63 (1.59%)  0/65 (0.00%) 
Human polyomavirus infection  1  1/63 (1.59%)  1/65 (1.54%) 
Infected lymphocele  1  0/63 (0.00%)  2/65 (3.08%) 
Infection  1  2/63 (3.17%)  1/65 (1.54%) 
Oesophageal candidiasis  1  0/63 (0.00%)  1/65 (1.54%) 
Otitis media  1  1/63 (1.59%)  0/65 (0.00%) 
Perinephric abscess  1  1/63 (1.59%)  0/65 (0.00%) 
Pneumonia  1  4/63 (6.35%)  0/65 (0.00%) 
Renal abscess  1  0/63 (0.00%)  1/65 (1.54%) 
Renal cyst infection  1  0/63 (0.00%)  1/65 (1.54%) 
Respiratory tract infection  1  0/63 (0.00%)  1/65 (1.54%) 
Sepsis  1  0/63 (0.00%)  1/65 (1.54%) 
Staphylococcal infection  1  1/63 (1.59%)  0/65 (0.00%) 
Tracheobronchitis  1  1/63 (1.59%)  0/65 (0.00%) 
Upper respiratory tract infection  1  1/63 (1.59%)  0/65 (0.00%) 
Urinary tract infection  1  5/63 (7.94%)  9/65 (13.85%) 
Urosepsis  1  1/63 (1.59%)  4/65 (6.15%) 
Wound abscess  1  1/63 (1.59%)  0/65 (0.00%) 
Wound infection  1  2/63 (3.17%)  0/65 (0.00%) 
Wound infection bacterial  1  1/63 (1.59%)  0/65 (0.00%) 
Wound infection staphylococcal  1  1/63 (1.59%)  0/65 (0.00%) 
Injury, poisoning and procedural complications     
Anastomotic leak  1  1/63 (1.59%)  0/65 (0.00%) 
Arteriovenous graft thrombosis  1  2/63 (3.17%)  0/65 (0.00%) 
Clavicle fracture  1  0/63 (0.00%)  1/65 (1.54%) 
Complications of transplanted kidney  1  2/63 (3.17%)  3/65 (4.62%) 
Femoral neck fracture  1  0/63 (0.00%)  1/65 (1.54%) 
Foot fracture  1  0/63 (0.00%)  1/65 (1.54%) 
Graft loss  1  2/63 (3.17%)  2/65 (3.08%) 
Incisional hernia  1  1/63 (1.59%)  1/65 (1.54%) 
Perirenal haematoma  1  0/63 (0.00%)  2/65 (3.08%) 
Post procedural urine leak  1  2/63 (3.17%)  1/65 (1.54%) 
Seroma  1  0/63 (0.00%)  1/65 (1.54%) 
Shunt aneurysm  1  1/63 (1.59%)  0/65 (0.00%) 
Thoracic vertebral fracture  1  1/63 (1.59%)  0/65 (0.00%) 
Transplant failure  1  0/63 (0.00%)  5/65 (7.69%) 
Wound dehiscence  1  1/63 (1.59%)  1/65 (1.54%) 
Investigations     
Blood creatinine increased  1  9/63 (14.29%)  6/65 (9.23%) 
Haemoglobin decreased  1  0/63 (0.00%)  1/65 (1.54%) 
Metabolism and nutrition disorders     
Calciphylaxis  1  0/63 (0.00%)  1/65 (1.54%) 
Dehydration  1  1/63 (1.59%)  0/65 (0.00%) 
Hyperglycaemia  1  0/63 (0.00%)  1/65 (1.54%) 
Hypervolaemia  1  0/63 (0.00%)  1/65 (1.54%) 
Nervous system disorders     
Cerebral infarction  1  0/63 (0.00%)  1/65 (1.54%) 
Cerebrovascular accident  1  0/63 (0.00%)  1/65 (1.54%) 
Migraine  1  0/63 (0.00%)  1/65 (1.54%) 
Transient ischaemic attack  1  1/63 (1.59%)  1/65 (1.54%) 
Uraemic encephalopathy  1  0/63 (0.00%)  1/65 (1.54%) 
Psychiatric disorders     
Delirium  1  0/63 (0.00%)  1/65 (1.54%) 
Depression  1  1/63 (1.59%)  0/65 (0.00%) 
Hallucination, visual  1  1/63 (1.59%)  0/65 (0.00%) 
Renal and urinary disorders     
Haematuria  1  0/63 (0.00%)  1/65 (1.54%) 
Renal artery occlusion  1  1/63 (1.59%)  0/65 (0.00%) 
Renal artery stenosis  1  2/63 (3.17%)  0/65 (0.00%) 
Renal failure  1  1/63 (1.59%)  0/65 (0.00%) 
Renal failure acute  1  4/63 (6.35%)  5/65 (7.69%) 
Ureteral necrosis  1  0/63 (0.00%)  1/65 (1.54%) 
Urinary retention  1  2/63 (3.17%)  1/65 (1.54%) 
Urinary tract obstruction  1  1/63 (1.59%)  1/65 (1.54%) 
Urinoma  1  1/63 (1.59%)  2/65 (3.08%) 
Vesicoureteric reflux  1  1/63 (1.59%)  0/65 (0.00%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  0/63 (0.00%)  1/65 (1.54%) 
Pelvic congestion  1  2/63 (3.17%)  2/65 (3.08%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/63 (0.00%)  1/65 (1.54%) 
Chronic obstructive pulmonary disease  1  0/63 (0.00%)  1/65 (1.54%) 
Dyspnoea  1  0/63 (0.00%)  1/65 (1.54%) 
Pneumothorax  1  1/63 (1.59%)  0/65 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin inflammation  1  1/63 (1.59%)  0/65 (0.00%) 
Surgical and medical procedures     
Pneumatic compression therapy  1  0/63 (0.00%)  1/65 (1.54%) 
Wound treatment  1  1/63 (1.59%)  0/65 (0.00%) 
Vascular disorders     
Deep vein thrombosis  1  0/63 (0.00%)  2/65 (3.08%) 
Femoral arterial stenosis  1  1/63 (1.59%)  0/65 (0.00%) 
Haematoma  1  1/63 (1.59%)  0/65 (0.00%) 
Hypertension  1  2/63 (3.17%)  1/65 (1.54%) 
Lymphocele  1  4/63 (6.35%)  3/65 (4.62%) 
Peripheral artery aneurysm  1  1/63 (1.59%)  0/65 (0.00%) 
Peripheral artery dissection  1  1/63 (1.59%)  0/65 (0.00%) 
Shock  1  0/63 (0.00%)  1/65 (1.54%) 
Shock haemorrhagic  1  1/63 (1.59%)  0/65 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intensified Mycophenolate Sodium Standard Mycophenolate Sodium
Affected / at Risk (%) Affected / at Risk (%)
Total   62/63 (98.41%)   63/65 (96.92%) 
Blood and lymphatic system disorders     
Anaemia  1  16/63 (25.40%)  19/65 (29.23%) 
Leukopenia  1  12/63 (19.05%)  14/65 (21.54%) 
Thrombocytopenia  1  4/63 (6.35%)  1/65 (1.54%) 
Gastrointestinal disorders     
Abdominal pain  1  11/63 (17.46%)  5/65 (7.69%) 
Constipation  1  19/63 (30.16%)  15/65 (23.08%) 
Diarrhoea  1  19/63 (30.16%)  23/65 (35.38%) 
Dyspepsia  1  4/63 (6.35%)  0/65 (0.00%) 
Flatulence  1  13/63 (20.63%)  7/65 (10.77%) 
Nausea  1  23/63 (36.51%)  19/65 (29.23%) 
Vomiting  1  16/63 (25.40%)  16/65 (24.62%) 
General disorders     
Oedema  1  16/63 (25.40%)  14/65 (21.54%) 
Oedema peripheral  1  15/63 (23.81%)  16/65 (24.62%) 
Pain  1  1/63 (1.59%)  4/65 (6.15%) 
Pyrexia  1  3/63 (4.76%)  8/65 (12.31%) 
Infections and infestations     
BK virus infection  1  4/63 (6.35%)  1/65 (1.54%) 
Cytomegalovirus infection  1  2/63 (3.17%)  7/65 (10.77%) 
Nasopharyngitis  1  3/63 (4.76%)  8/65 (12.31%) 
Pneumonia  1  1/63 (1.59%)  7/65 (10.77%) 
Rhinitis  1  4/63 (6.35%)  5/65 (7.69%) 
Urinary tract infection  1  24/63 (38.10%)  26/65 (40.00%) 
Injury, poisoning and procedural complications     
Complications of transplanted kidney  1  20/63 (31.75%)  22/65 (33.85%) 
Procedural pain  1  3/63 (4.76%)  4/65 (6.15%) 
Wound complication  1  9/63 (14.29%)  13/65 (20.00%) 
Wound dehiscence  1  7/63 (11.11%)  9/65 (13.85%) 
Investigations     
Blood creatinine increased  1  7/63 (11.11%)  12/65 (18.46%) 
Blood glucose increased  1  5/63 (7.94%)  2/65 (3.08%) 
C-reactive protein increased  1  7/63 (11.11%)  1/65 (1.54%) 
Haemoglobin decreased  1  4/63 (6.35%)  1/65 (1.54%) 
Weight increased  1  4/63 (6.35%)  1/65 (1.54%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  5/63 (7.94%)  6/65 (9.23%) 
Hypercholesterolaemia  1  7/63 (11.11%)  6/65 (9.23%) 
Hyperkalaemia  1  9/63 (14.29%)  9/65 (13.85%) 
Hyperphosphataemia  1  4/63 (6.35%)  6/65 (9.23%) 
Hyperuricaemia  1  4/63 (6.35%)  5/65 (7.69%) 
Hypocalcaemia  1  19/63 (30.16%)  14/65 (21.54%) 
Hypokalaemia  1  23/63 (36.51%)  31/65 (47.69%) 
Hypomagnesaemia  1  6/63 (9.52%)  5/65 (7.69%) 
Hypophosphataemia  1  13/63 (20.63%)  10/65 (15.38%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/63 (3.17%)  5/65 (7.69%) 
Muscle spasms  1  7/63 (11.11%)  1/65 (1.54%) 
Pain in extremity  1  3/63 (4.76%)  5/65 (7.69%) 
Nervous system disorders     
Headache  1  8/63 (12.70%)  9/65 (13.85%) 
Tremor  1  4/63 (6.35%)  3/65 (4.62%) 
Psychiatric disorders     
Sleep disorder  1  11/63 (17.46%)  12/65 (18.46%) 
Renal and urinary disorders     
Bladder pain  1  6/63 (9.52%)  9/65 (13.85%) 
Dysuria  1  6/63 (9.52%)  3/65 (4.62%) 
Haematuria  1  7/63 (11.11%)  5/65 (7.69%) 
Residual urine  1  4/63 (6.35%)  1/65 (1.54%) 
Urinary retention  1  6/63 (9.52%)  2/65 (3.08%) 
Urinary tract obstruction  1  1/63 (1.59%)  7/65 (10.77%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  7/63 (11.11%)  7/65 (10.77%) 
Dyspnoea  1  5/63 (7.94%)  8/65 (12.31%) 
Vascular disorders     
Haematoma  1  0/63 (0.00%)  5/65 (7.69%) 
Hypertension  1  10/63 (15.87%)  4/65 (6.15%) 
Hypotension  1  8/63 (12.70%)  3/65 (4.62%) 
Lymphocele  1  4/63 (6.35%)  14/65 (21.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00369278     History of Changes
Other Study ID Numbers: CERL080ADE12
First Submitted: August 25, 2006
First Posted: August 29, 2006
Results First Submitted: December 15, 2010
Results First Posted: January 12, 2011
Last Update Posted: March 29, 2011