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Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis (LEAP)

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ClinicalTrials.gov Identifier: NCT00853242
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : May 1, 2015
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Kidney Failure, Chronic
Interventions Drug: Placebo
Drug: Genz-644470
Drug: Sevelamer carbonate
Enrollment 349
Recruitment Details The study was conducted at 64 centers in the United States between 11 February 2009 and 20 August 2009.
Pre-assignment Details A total of 670 participants were screened of which 321 were screen failure and 349 participants were randomized. After screening, participants entered a two-week phosphate binder washout period prior to randomization.
Arm/Group Title Placebo Genz-644470 2.4 Grams Per Day (g/Day) Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day
Hide Arm/Group Description Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks. Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Period Title: Overall Study
Started 50 50 49 50 50 51 49
Treated 50 49 48 50 50 51 48
Completed 47 47 46 46 46 49 44
Not Completed 3 3 3 4 4 2 5
Reason Not Completed
Adverse Event             0             1             1             0             3             1             1
Noncompliant             0             0             0             0             1             0             0
Withdrawal by Subject             1             2             0             4             0             0             2
Other             2             0             2             0             0             1             2
Arm/Group Title Placebo Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day Total
Hide Arm/Group Description Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks. Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks. Total of all reporting groups
Overall Number of Baseline Participants 50 49 48 50 50 51 48 346
Hide Baseline Analysis Population Description
Safety Set included all randomized participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 49 participants 48 participants 50 participants 50 participants 51 participants 48 participants 346 participants
59.1  (13.6) 58.3  (12.0) 54.7  (11.3) 56.7  (13.3) 54.6  (13.4) 56.6  (11.9) 53.6  (13.1) 56.2  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 48 participants 50 participants 50 participants 51 participants 48 participants 346 participants
Female
20
  40.0%
24
  49.0%
23
  47.9%
19
  38.0%
22
  44.0%
21
  41.2%
15
  31.3%
144
  41.6%
Male
30
  60.0%
25
  51.0%
25
  52.1%
31
  62.0%
28
  56.0%
30
  58.8%
33
  68.8%
202
  58.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 48 participants 50 participants 50 participants 51 participants 48 participants 346 participants
Asian 0 2 1 1 2 0 2 8
Black or African American 21 20 25 25 23 25 22 161
White 29 27 22 22 25 25 23 173
Other 0 0 0 2 0 1 1 4
Serum Phosphorus Level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 48 participants 50 participants 50 participants 51 participants 48 participants 346 participants
less than (<) 7.0 milligram per deciliter (mg/dL) 22 22 21 21 22 20 17 145
Greater Than or Equal to (>=) 7.0 mg/dL 28 27 27 29 28 31 31 201
1.Primary Outcome
Title Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
Hide Description [Not Specified]
Time Frame Baseline, Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure less than or equal to (<=) 3 days after date of last study drug.
Arm/Group Title Placebo Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day
Hide Arm/Group Description:
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Overall Number of Participants Analyzed 50 48 47 46
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.0  (1.3) -0.6  (1.5) -1.2  (1.6) -1.8  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Genz-644470 2.4 g/Day
Comments Analysis was performed using Wilcoxon rank sum tests.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0249
Comments [Not Specified]
Method Wilcoxon Rank Sum Tests
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Genz-644470 4.8 g/Day
Comments Analysis was performed using Wilcoxon rank sum tests.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon Rank Sum Tests
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Genz-644470 7.2 g/Day
Comments Analysis was performed using Wilcoxon rank sum tests.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon Rank Sum Tests
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
Hide Description [Not Specified]
Time Frame Baseline, Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who received at least one dose of study drug and had baseline and at least one post-baseline phosphorus measure <= 3 days after date of last study drug.
Arm/Group Title Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day
Hide Arm/Group Description:
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Overall Number of Participants Analyzed 48 47 46 49 48 47
Mean (Standard Deviation)
Unit of Measure: mg/dL
-0.6  (1.5) -1.2  (1.6) -1.8  (1.9) -0.9  (1.7) -1.3  (1.9) -2.0  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Genz-644470 2.4 g/Day, Sevelamer Carbonate 2.4 g/Day
Comments Analysis was performed using Wilcoxon rank sum tests.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2647
Comments [Not Specified]
Method Wilcoxon Rank Sum Tests
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Genz-644470 4.8 g/Day, Sevelamer Carbonate 4.8 g/Day
Comments Analysis was performed using Wilcoxon rank sum tests.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7944
Comments [Not Specified]
Method Wilcoxon Rank Sum Tests
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Genz-644470 7.2 g/Day, Sevelamer Carbonate 7.2 g/Day
Comments Analysis was performed using Wilcoxon rank sum tests.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3724
Comments [Not Specified]
Method Wilcoxon Rank Sum Tests
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
Hide Description [Not Specified]
Time Frame Baseline, Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Placebo Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day
Hide Arm/Group Description:
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Overall Number of Participants Analyzed 50 48 47 46 49 48 47
Mean (Standard Deviation)
Unit of Measure: mg^2/dL^2
-0.1  (12.7) -4.5  (12.3) -9.2  (14.7) -16.1  (16.1) -8.3  (17.4) -10.3  (17.5) -17.5  (13.4)
4.Secondary Outcome
Title Change From Baseline in Total Cholesterol at Day 22
Hide Description [Not Specified]
Time Frame Baseline, Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Placebo Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day
Hide Arm/Group Description:
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Overall Number of Participants Analyzed 50 48 47 46 49 48 47
Mean (Standard Deviation)
Unit of Measure: mg/dL
-3.8  (20.9) -13.5  (20.7) -11.2  (19.7) -17.8  (22.8) -2.9  (17.1) -15.8  (16.3) -18.1  (27.8)
5.Secondary Outcome
Title Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
Hide Description [Not Specified]
Time Frame Baseline, Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title Placebo Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day
Hide Arm/Group Description:
Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Overall Number of Participants Analyzed 50 48 47 46 49 48 47
Mean (Standard Deviation)
Unit of Measure: mg/dL
-1.3  (17.4) -15.4  (19.8) -13.2  (18.6) -21.9  (23.5) -7.5  (13.0) -17.7  (14.8) -22.6  (24.5)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 22) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (from the first dose of study drug up to 30 days after last dose of study drug). The Safety Set included all randomized participants who were treated with at least one dose of study drug.
 
Arm/Group Title Placebo Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day
Hide Arm/Group Description Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks. Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
All-Cause Mortality
Placebo Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/50 (8.00%)   2/49 (4.08%)   6/48 (12.50%)   6/50 (12.00%)   8/50 (16.00%)   5/51 (9.80%)   5/48 (10.42%) 
Blood and lymphatic system disorders               
Anaemia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Cardiac disorders               
Acute myocardial infarction  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Cardiac failure congestive  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Cardio-respiratory arrest  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Coronary artery disease  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  1/50 (2.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Myocardial infarction  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Tachycardia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Gastrointestinal disorders               
Abdominal pain upper  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Colitis  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Diverticulum  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Haemorrhoidal haemorrhage  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Intestinal perforation  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Oesophagitis  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Pancreatitis acute  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
General disorders               
Asthenia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Non-cardiac chest pain  1  1/50 (2.00%)  1/49 (2.04%)  0/48 (0.00%)  1/50 (2.00%)  1/50 (2.00%)  1/51 (1.96%)  0/48 (0.00%) 
Infections and infestations               
Appendicitis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Arteriovenous graft site abscess  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Bacteraemia  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Catheter bacteraemia  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Cellulitis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Endocarditis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Gangrene  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Gastroenteritis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Osteomyelitis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Pneumonia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Sepsis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Septic shock  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Injury, poisoning and procedural complications               
Arteriovenous fistula site complication  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Arteriovenous fistula thrombosis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Arteriovenous graft site haemorrhage  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Arteriovenous graft thrombosis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Hip fracture  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Procedural nausea  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Metabolism and nutrition disorders               
Fluid overload  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  1/50 (2.00%)  0/50 (0.00%)  1/51 (1.96%)  1/48 (2.08%) 
Hyperkalaemia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Musculoskeletal and connective tissue disorders               
Intervertebral disc protrusion  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Osteoarthritis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Nervous system disorders               
Cerebrovascular accident  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Presyncope  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Syncope  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Renal and urinary disorders               
Haematuria  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Pleural effusion  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Skin and subcutaneous tissue disorders               
Skin ulcer  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Surgical and medical procedures               
Renal transplant  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Vascular disorders               
Malignant hypertension  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Peripheral vascular disorder  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Genz-644470 2.4 g/Day Genz-644470 4.8 g/Day Genz-644470 7.2 g/Day Sevelamer Carbonate 2.4 g/Day Sevelamer Carbonate 4.8 g/Day Sevelamer Carbonate 7.2 g/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/50 (34.00%)   17/49 (34.69%)   17/48 (35.42%)   25/50 (50.00%)   22/50 (44.00%)   25/51 (49.02%)   22/48 (45.83%) 
Blood and lymphatic system disorders               
Anaemia  1  1/50 (2.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Monocytosis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Congenital, familial and genetic disorders               
Congenital cystic kidney disease  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Endocrine disorders               
Hyperparathyroidism secondary  1  2/50 (4.00%)  0/49 (0.00%)  1/48 (2.08%)  2/50 (4.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Eye disorders               
Cataract  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Glaucoma  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Gastrointestinal disorders               
Abdominal discomfort  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Abdominal distension  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Abdominal pain  1  1/50 (2.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Abdominal pain upper  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  1/50 (2.00%)  1/51 (1.96%)  0/48 (0.00%) 
Colonic polyp  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Constipation  1  1/50 (2.00%)  2/49 (4.08%)  0/48 (0.00%)  1/50 (2.00%)  2/50 (4.00%)  1/51 (1.96%)  0/48 (0.00%) 
Diarrhoea  1  2/50 (4.00%)  1/49 (2.04%)  1/48 (2.08%)  3/50 (6.00%)  1/50 (2.00%)  4/51 (7.84%)  4/48 (8.33%) 
Dry mouth  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Dyspepsia  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  1/51 (1.96%)  1/48 (2.08%) 
Flatulence  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Gastric ulcer  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Gastritis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Gastrooesophageal reflux disease  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  1/48 (2.08%) 
Gingival pain  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Haemorrhoidal haemorrhage  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Hypoaesthesia oral  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Nausea  1  2/50 (4.00%)  3/49 (6.12%)  3/48 (6.25%)  3/50 (6.00%)  2/50 (4.00%)  3/51 (5.88%)  7/48 (14.58%) 
Retching  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Toothache  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Vomiting  1  1/50 (2.00%)  0/49 (0.00%)  2/48 (4.17%)  1/50 (2.00%)  1/50 (2.00%)  2/51 (3.92%)  3/48 (6.25%) 
General disorders               
Asthenia  1  1/50 (2.00%)  0/49 (0.00%)  1/48 (2.08%)  1/50 (2.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Catheter related complication  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Catheter site swelling  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Chills  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Face oedema  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Non-cardiac chest pain  1  0/50 (0.00%)  0/49 (0.00%)  2/48 (4.17%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Oedema  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Oedema peripheral  1  1/50 (2.00%)  0/49 (0.00%)  1/48 (2.08%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Pyrexia  1  0/50 (0.00%)  1/49 (2.04%)  1/48 (2.08%)  1/50 (2.00%)  1/50 (2.00%)  1/51 (1.96%)  0/48 (0.00%) 
Infections and infestations               
Bronchitis  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Catheter related infection  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Cellulitis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Gastroenteritis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Gingival infection  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Hordeolum  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Influenza  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Localised infection  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Nasopharyngitis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Otitis externa  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Sinusitis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  2/51 (3.92%)  0/48 (0.00%) 
Upper respiratory tract infection  1  1/50 (2.00%)  0/49 (0.00%)  2/48 (4.17%)  1/50 (2.00%)  0/50 (0.00%)  1/51 (1.96%)  2/48 (4.17%) 
Urinary tract infection  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Injury, poisoning and procedural complications               
Arteriovenous fistula site complication  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  1/48 (2.08%) 
Arteriovenous fistula thrombosis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Arteriovenous graft aneurysm  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Arteriovenous graft thrombosis  1  0/50 (0.00%)  1/49 (2.04%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Contusion  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Excoriation  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Fall  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Limb injury  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Muscle strain  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Procedural headache  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Procedural hypotension  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  1/51 (1.96%)  1/48 (2.08%) 
Vascular graft complication  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Investigations               
Blood triglycerides increased  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Heart rate irregular  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Weight increased  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Metabolism and nutrition disorders               
Anorexia  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Decreased appetite  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  1/48 (2.08%) 
Dyslipidaemia  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Fluid overload  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Hypercalcaemia  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  1/50 (2.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Hyperglycaemia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Hyperkalaemia  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  1/50 (2.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Hyperlipidaemia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  2/48 (4.17%) 
Hyperphosphataemia  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  2/50 (4.00%)  1/51 (1.96%)  1/48 (2.08%) 
Hyperuricaemia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Hypoalbuminaemia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Hypocalcaemia  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  1/50 (2.00%)  0/51 (0.00%)  2/48 (4.17%) 
Hypoglycaemia  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Hypophosphataemia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Vitamin D deficiency  1  1/50 (2.00%)  0/49 (0.00%)  1/48 (2.08%)  1/50 (2.00%)  1/50 (2.00%)  0/51 (0.00%)  1/48 (2.08%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  1/50 (2.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Back pain  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Muscle spasms  1  2/50 (4.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Muscular weakness  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  1/51 (1.96%)  0/48 (0.00%) 
Neck pain  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Osteoarthritis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  1/51 (1.96%)  0/48 (0.00%) 
Pain in extremity  1  1/50 (2.00%)  1/49 (2.04%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Rheumatoid arthritis  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Nervous system disorders               
Dizziness  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  2/48 (4.17%) 
Dysgeusia  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Headache  1  0/50 (0.00%)  2/49 (4.08%)  0/48 (0.00%)  2/50 (4.00%)  0/50 (0.00%)  1/51 (1.96%)  1/48 (2.08%) 
Lethargy  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Migraine  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Restless legs syndrome  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Somnolence  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Psychiatric disorders               
Anxiety  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Depression  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Insomnia  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Renal and urinary disorders               
Nephrolithiasis  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough  1  0/50 (0.00%)  1/49 (2.04%)  3/48 (6.25%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Dyspnoea  1  1/50 (2.00%)  1/49 (2.04%)  1/48 (2.08%)  4/50 (8.00%)  1/50 (2.00%)  1/51 (1.96%)  1/48 (2.08%) 
Dyspnoea exertional  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Hypocapnia  1  1/50 (2.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  1/50 (2.00%)  0/51 (0.00%)  0/48 (0.00%) 
Nasal congestion  1  0/50 (0.00%)  1/49 (2.04%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Oropharyngeal pain  1  1/50 (2.00%)  0/49 (0.00%)  1/48 (2.08%)  2/50 (4.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Rhinorrhoea  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Sneezing  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/48 (2.08%) 
Skin and subcutaneous tissue disorders               
Acne  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Blister  1  1/50 (2.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  1/51 (1.96%)  0/48 (0.00%) 
Pruritus  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  2/50 (4.00%)  1/50 (2.00%)  0/51 (0.00%)  1/48 (2.08%) 
Skin ulcer  1  0/50 (0.00%)  0/49 (0.00%)  0/48 (0.00%)  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Vascular disorders               
Hot flush  1  0/50 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Hypertension  1  1/50 (2.00%)  1/49 (2.04%)  1/48 (2.08%)  0/50 (0.00%)  0/50 (0.00%)  2/51 (3.92%)  0/48 (0.00%) 
Hypotension  1  0/50 (0.00%)  1/49 (2.04%)  0/48 (0.00%)  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  0/48 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00853242     History of Changes
Other Study ID Numbers: APB00108
First Submitted: February 27, 2009
First Posted: March 2, 2009
Results First Submitted: April 15, 2015
Results First Posted: May 1, 2015
Last Update Posted: May 1, 2015