Trial Outcomes & Findings for A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia (NCT NCT00542815)
NCT ID: NCT00542815
Last Updated: 2026-01-07
Results Overview
Change from Baseline to Week 52 (LOCF)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
632 participants
Primary outcome timeframe
52 weeks (Baseline-52 weeks)
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
MCI-196 From E07 / E08 Studies
3, 6, 9, 12, or 15g / day as titrated
|
MCI-196 From E07 Study
3, 6, 9, 12, or 15g / day as titrated
|
Sevelamer From E07 Study
2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
|
|---|---|---|---|
|
Overall Study
STARTED
|
432
|
76
|
124
|
|
Overall Study
COMPLETED
|
326
|
44
|
92
|
|
Overall Study
NOT COMPLETED
|
106
|
32
|
32
|
Reasons for withdrawal
| Measure |
MCI-196 From E07 / E08 Studies
3, 6, 9, 12, or 15g / day as titrated
|
MCI-196 From E07 Study
3, 6, 9, 12, or 15g / day as titrated
|
Sevelamer From E07 Study
2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
19
|
6
|
9
|
|
Overall Study
Death
|
10
|
7
|
3
|
|
Overall Study
Lack of Efficacy
|
9
|
2
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
41
|
5
|
8
|
|
Overall Study
Other reasons
|
24
|
10
|
10
|
Baseline Characteristics
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Baseline characteristics by cohort
| Measure |
MCI-196 From E07 / E08 Studies
n=432 Participants
3, 6, 9, 12, or 15g / day as titrated
|
MCI-196 From E07 Study
n=76 Participants
3, 6, 9, 12, or 15g / day as titrated
|
Sevelamer From E07 Study
n=124 Participants
2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
|
Total
n=632 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<65 years
|
374 participants
n=37 Participants
|
55 participants
n=56 Participants
|
77 participants
n=95 Participants
|
506 participants
n=61 Participants
|
|
Age, Customized
>=65 years
|
58 participants
n=37 Participants
|
21 participants
n=56 Participants
|
47 participants
n=95 Participants
|
126 participants
n=61 Participants
|
|
Sex: Female, Male
Female
|
203 Participants
n=37 Participants
|
25 Participants
n=56 Participants
|
53 Participants
n=95 Participants
|
281 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
229 Participants
n=37 Participants
|
51 Participants
n=56 Participants
|
71 Participants
n=95 Participants
|
351 Participants
n=61 Participants
|
PRIMARY outcome
Timeframe: 52 weeks (Baseline-52 weeks)Population: ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.
Change from Baseline to Week 52 (LOCF)
Outcome measures
| Measure |
MCI-196 From E07 / E08 Studies
n=429 Participants
3, 6, 9, 12, or 15g / day as titrated
|
MCI-196 From E07 Study
n=75 Participants
3, 6, 9, 12, or 15g / day as titrated
|
Sevelamer From E07 Study
n=124 Participants
2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
|
|---|---|---|---|
|
The Change in Serum Phosphorus for MCI-196 and Sevelamer
|
-1.23 mg / dL
Standard Deviation 1.78
|
-1.47 mg / dL
Standard Deviation 1.68
|
-2.26 mg / dL
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: 52 weeks (Baseline-52 weeks)Population: ITT2 population included all subjects who received enrolment number into MCI-196-E10, took at least 1 dose of study medication in original study and had at least 1 post-enrolment efficacy value after start of study medication in MCI-196-E10. Data collected from start of original studies to end of MCI-196-E10 were analysed for this population.
Percent Change from Baseline to Week 52 (LOCF)
Outcome measures
| Measure |
MCI-196 From E07 / E08 Studies
n=429 Participants
3, 6, 9, 12, or 15g / day as titrated
|
MCI-196 From E07 Study
n=75 Participants
3, 6, 9, 12, or 15g / day as titrated
|
Sevelamer From E07 Study
n=124 Participants
2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
|
|---|---|---|---|
|
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
|
-26.22 percentage change of LDL-cholesterol
Standard Deviation 27.08
|
-30.62 percentage change of LDL-cholesterol
Standard Deviation 20.12
|
-28.66 percentage change of LDL-cholesterol
Standard Deviation 23.61
|
Adverse Events
MCI-196 From E07/E08 Studies
Serious events: 74 serious events
Other events: 310 other events
Deaths: 0 deaths
MCI-196 From E07 Study
Serious events: 31 serious events
Other events: 75 other events
Deaths: 0 deaths
Sevelamer From E07 Study
Serious events: 48 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MCI-196 From E07/E08 Studies
n=432 participants at risk
3, 6, 9, 12, or 15g / day as titrated
|
MCI-196 From E07 Study
n=76 participants at risk
3, 6, 9, 12, or 15g / day as titrated
|
Sevelamer From E07 Study
n=124 participants at risk
2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
2/432
|
2.6%
2/76
|
2.4%
3/124
|
|
Cardiac disorders
Acute coronary syndrome
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
1/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/432
|
0.00%
0/76
|
1.6%
2/124
|
|
Cardiac disorders
Angina unstable
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
5/432
|
3.9%
3/76
|
0.00%
0/124
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Bundle branch block left
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Cardiac disorders
Cardiac arrest
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Cardiac failure acute
|
0.23%
1/432
|
1.3%
1/76
|
0.81%
1/124
|
|
Cardiac disorders
Cardiac failure congestive
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Cardiac disorders
Myocardial infarction
|
0.46%
2/432
|
2.6%
2/76
|
0.81%
1/124
|
|
Cardiac disorders
Myocardial ischaemia
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Cardiac disorders
Pericarditis
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Cardiac disorders
Ventricular fibrillation
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
1/432
|
1.3%
1/76
|
0.81%
1/124
|
|
Endocrine disorders
Hyperparathyroidism
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Endocrine disorders
Parathyroid gland enlargement
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Eye disorders
Iritis
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Gastrointestinal disorders
Abdominal pain
|
0.23%
1/432
|
0.00%
0/76
|
1.6%
2/124
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Gastrointestinal disorders
Ileal perforation
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Gastrointestinal disorders
Peritonitis
|
0.69%
3/432
|
0.00%
0/76
|
1.6%
2/124
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.23%
1/432
|
0.00%
0/76
|
0.81%
1/124
|
|
General disorders
Cardiac death
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
General disorders
Catheter related complication
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
General disorders
Catheter site haematoma
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
General disorders
Catheter site phlebitis
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
General disorders
Mass
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
General disorders
Pyrexia
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Infections and infestations
Abdominal abscess
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Infections and infestations
Acute sinusitis
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Infections and infestations
Aeromona infection
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Infections and infestations
Bronchitis
|
0.46%
2/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Infections and infestations
Catheter sepsis
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Infections and infestations
Cellulitis
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Infections and infestations
Clostridium difficile colitis
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Infections and infestations
Furuncle
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Infections and infestations
Gangrene
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Infections and infestations
Pneumonia
|
1.6%
7/432
|
3.9%
3/76
|
0.81%
1/124
|
|
Infections and infestations
Pyelonephritis chronic
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Infections and infestations
Pyonephrosis
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Infections and infestations
Salpingitis
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Infections and infestations
Sepsis
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Infections and infestations
Upper respiratory tract infection
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Infections and infestations
Urinary tract infection
|
0.23%
1/432
|
1.3%
1/76
|
0.81%
1/124
|
|
Infections and infestations
Wound sepsis
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.46%
2/432
|
2.6%
2/76
|
0.81%
1/124
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.2%
5/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Device failure
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Injury, poisoning and procedural complications
Dialysis device complication
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Shunt malfunction
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
0/432
|
0.00%
0/76
|
1.6%
2/124
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Investigations
Arteriogram coronary
|
0.23%
1/432
|
1.3%
1/76
|
1.6%
2/124
|
|
Investigations
Hepatic enzyme increased
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.46%
2/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.23%
1/432
|
1.3%
1/76
|
0.81%
1/124
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
Soft tissue haemorrhage
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Nervous system disorders
Brain stem ischaemia
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Nervous system disorders
Encephalomalacia
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Nervous system disorders
Ischaemic stroke
|
0.23%
1/432
|
1.3%
1/76
|
1.6%
2/124
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Psychiatric disorders
Confusional state
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Renal and urinary disorders
Calculus bladder
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Renal and urinary disorders
Reduced bladder capacity
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Renal and urinary disorders
Renal artery thrombosis
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Renal and urinary disorders
Renal failure chronic
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/432
|
0.00%
0/76
|
1.6%
2/124
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.46%
2/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.23%
1/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.23%
1/432
|
1.3%
1/76
|
0.81%
1/124
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
1/432
|
1.3%
1/76
|
0.81%
1/124
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.46%
2/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Vascular disorders
Accelerated hypertension
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Vascular disorders
Brachiocephalic vein stenosis
|
0.46%
2/432
|
2.6%
2/76
|
0.81%
1/124
|
|
Vascular disorders
Circulatory collapse
|
0.46%
2/432
|
2.6%
2/76
|
0.00%
0/124
|
|
Vascular disorders
Extremity necrosis
|
0.23%
1/432
|
1.3%
1/76
|
1.6%
2/124
|
|
Vascular disorders
Haematoma
|
0.00%
0/432
|
0.00%
0/76
|
1.6%
2/124
|
|
Vascular disorders
Hypertension
|
0.23%
1/432
|
0.00%
0/76
|
1.6%
2/124
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
1/432
|
0.00%
0/76
|
2.4%
3/124
|
|
Vascular disorders
Hypovolaemic shock
|
0.23%
1/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Vascular disorders
Venous insufficiency
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Vascular disorders
Venous occlusion
|
0.23%
1/432
|
0.00%
0/76
|
0.00%
0/124
|
Other adverse events
| Measure |
MCI-196 From E07/E08 Studies
n=432 participants at risk
3, 6, 9, 12, or 15g / day as titrated
|
MCI-196 From E07 Study
n=76 participants at risk
3, 6, 9, 12, or 15g / day as titrated
|
Sevelamer From E07 Study
n=124 participants at risk
2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.9%
34/432
|
17.1%
13/76
|
17.7%
22/124
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
1.4%
6/432
|
2.6%
2/76
|
0.81%
1/124
|
|
Cardiac disorders
Angina pectoris
|
1.2%
5/432
|
1.3%
1/76
|
3.2%
4/124
|
|
Cardiac disorders
Myocardial ischaemia
|
2.1%
9/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Ear and labyrinth disorders
Vertigo
|
1.4%
6/432
|
1.3%
1/76
|
3.2%
4/124
|
|
Endocrine disorders
Hyperparathyroidism
|
3.2%
14/432
|
6.6%
5/76
|
9.7%
12/124
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
1.2%
5/432
|
3.9%
3/76
|
3.2%
4/124
|
|
Eye disorders
Conjunctivitis
|
1.4%
6/432
|
2.6%
2/76
|
2.4%
3/124
|
|
Gastrointestinal disorders
Abdominal distension
|
3.2%
14/432
|
0.00%
0/76
|
0.81%
1/124
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
21/432
|
11.8%
9/76
|
10.5%
13/124
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.8%
25/432
|
10.5%
8/76
|
5.6%
7/124
|
|
Gastrointestinal disorders
Constipation
|
7.4%
32/432
|
18.4%
14/76
|
11.3%
14/124
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
31/432
|
19.7%
15/76
|
16.1%
20/124
|
|
Gastrointestinal disorders
Duodenitis
|
0.93%
4/432
|
2.6%
2/76
|
2.4%
3/124
|
|
Gastrointestinal disorders
Dyspepsia
|
9.3%
40/432
|
17.1%
13/76
|
7.3%
9/124
|
|
Gastrointestinal disorders
Flatulence
|
2.1%
9/432
|
2.6%
2/76
|
2.4%
3/124
|
|
Gastrointestinal disorders
Gastritis
|
2.3%
10/432
|
3.9%
3/76
|
1.6%
2/124
|
|
Gastrointestinal disorders
Gastritis erosive
|
2.1%
9/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.46%
2/432
|
2.6%
2/76
|
0.81%
1/124
|
|
Gastrointestinal disorders
Nausea
|
11.6%
50/432
|
10.5%
8/76
|
10.5%
13/124
|
|
Gastrointestinal disorders
Oesophagitis
|
0.69%
3/432
|
3.9%
3/76
|
0.81%
1/124
|
|
Gastrointestinal disorders
Toothache
|
0.69%
3/432
|
3.9%
3/76
|
2.4%
3/124
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
37/432
|
19.7%
15/76
|
10.5%
13/124
|
|
General disorders
Asthenia
|
4.4%
19/432
|
3.9%
3/76
|
1.6%
2/124
|
|
General disorders
Non-cardiac chest pain
|
0.93%
4/432
|
2.6%
2/76
|
1.6%
2/124
|
|
General disorders
Oedema peripheral
|
3.7%
16/432
|
11.8%
9/76
|
3.2%
4/124
|
|
General disorders
Pyrexia
|
2.8%
12/432
|
2.6%
2/76
|
5.6%
7/124
|
|
Infections and infestations
Bronchitis
|
3.5%
15/432
|
10.5%
8/76
|
8.9%
11/124
|
|
Infections and infestations
Catheter sepsis
|
0.46%
2/432
|
2.6%
2/76
|
0.81%
1/124
|
|
Infections and infestations
Cystitis
|
0.69%
3/432
|
0.00%
0/76
|
4.0%
5/124
|
|
Infections and infestations
Gastroenteritis
|
0.46%
2/432
|
0.00%
0/76
|
2.4%
3/124
|
|
Infections and infestations
Influenza
|
3.0%
13/432
|
3.9%
3/76
|
6.5%
8/124
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
13/432
|
10.5%
8/76
|
11.3%
14/124
|
|
Infections and infestations
Pharyngitis
|
1.6%
7/432
|
3.9%
3/76
|
4.0%
5/124
|
|
Infections and infestations
Respiratory tract infection
|
2.3%
10/432
|
5.3%
4/76
|
0.00%
0/124
|
|
Infections and infestations
Respiratory tract infection viral
|
2.1%
9/432
|
0.00%
0/76
|
0.00%
0/124
|
|
Infections and infestations
Rhinitis
|
1.2%
5/432
|
2.6%
2/76
|
1.6%
2/124
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
7/432
|
5.3%
4/76
|
6.5%
8/124
|
|
Infections and infestations
Urinary tract infection
|
1.2%
5/432
|
3.9%
3/76
|
4.8%
6/124
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
1.6%
7/432
|
7.9%
6/76
|
1.6%
2/124
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haematoma
|
0.23%
1/432
|
1.3%
1/76
|
4.0%
5/124
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
3.0%
13/432
|
3.9%
3/76
|
4.0%
5/124
|
|
Injury, poisoning and procedural complications
Dialysis device complication
|
0.69%
3/432
|
2.6%
2/76
|
0.81%
1/124
|
|
Injury, poisoning and procedural complications
Haemodialysis-induced symptom
|
5.1%
22/432
|
10.5%
8/76
|
10.5%
13/124
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.23%
1/432
|
1.3%
1/76
|
2.4%
3/124
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
3.2%
14/432
|
2.6%
2/76
|
4.8%
6/124
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
3.7%
16/432
|
7.9%
6/76
|
7.3%
9/124
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.69%
3/432
|
3.9%
3/76
|
0.81%
1/124
|
|
Investigations
Blood parathyroid hormone increased
|
3.2%
14/432
|
2.6%
2/76
|
5.6%
7/124
|
|
Investigations
C-reactive protein increased
|
1.2%
5/432
|
6.6%
5/76
|
5.6%
7/124
|
|
Investigations
Electrocardiogram QT interval abnormal
|
0.46%
2/432
|
2.6%
2/76
|
0.00%
0/124
|
|
Investigations
Haemoglobin decreased
|
0.69%
3/432
|
0.00%
0/76
|
2.4%
3/124
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.0%
13/432
|
5.3%
4/76
|
2.4%
3/124
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.46%
2/432
|
2.6%
2/76
|
2.4%
3/124
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.9%
8/432
|
2.6%
2/76
|
0.00%
0/124
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.5%
15/432
|
7.9%
6/76
|
5.6%
7/124
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
1.6%
7/432
|
3.9%
3/76
|
1.6%
2/124
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.46%
2/432
|
2.6%
2/76
|
0.00%
0/124
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.4%
32/432
|
15.8%
12/76
|
8.1%
10/124
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.93%
4/432
|
3.9%
3/76
|
0.81%
1/124
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.46%
2/432
|
2.6%
2/76
|
2.4%
3/124
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.9%
21/432
|
3.9%
3/76
|
7.3%
9/124
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
14/432
|
13.2%
10/76
|
4.8%
6/124
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
6/432
|
2.6%
2/76
|
4.0%
5/124
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.1%
9/432
|
3.9%
3/76
|
0.81%
1/124
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.46%
2/432
|
2.6%
2/76
|
2.4%
3/124
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
6/432
|
5.3%
4/76
|
5.6%
7/124
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.46%
2/432
|
0.00%
0/76
|
3.2%
4/124
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
3.0%
13/432
|
1.3%
1/76
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
9/432
|
3.9%
3/76
|
10.5%
13/124
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.46%
2/432
|
2.6%
2/76
|
0.00%
0/124
|
|
Nervous system disorders
Headache
|
7.2%
31/432
|
11.8%
9/76
|
9.7%
12/124
|
|
Psychiatric disorders
Anxiety
|
1.2%
5/432
|
3.9%
3/76
|
1.6%
2/124
|
|
Psychiatric disorders
Insomnia
|
1.4%
6/432
|
1.3%
1/76
|
3.2%
4/124
|
|
Renal and urinary disorders
Anuria
|
0.46%
2/432
|
2.6%
2/76
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.69%
3/432
|
2.6%
2/76
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.46%
2/432
|
2.6%
2/76
|
0.81%
1/124
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
16/432
|
10.5%
8/76
|
7.3%
9/124
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
10/432
|
7.9%
6/76
|
4.8%
6/124
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
6/432
|
0.00%
0/76
|
2.4%
3/124
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
6/432
|
3.9%
3/76
|
3.2%
4/124
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.5%
15/432
|
3.9%
3/76
|
5.6%
7/124
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.69%
3/432
|
2.6%
2/76
|
2.4%
3/124
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.23%
1/432
|
1.3%
1/76
|
4.0%
5/124
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.46%
2/432
|
1.3%
1/76
|
2.4%
3/124
|
|
Surgical and medical procedures
Renal transplant
|
2.8%
12/432
|
9.2%
7/76
|
4.0%
5/124
|
|
Vascular disorders
Accelerated hypertension
|
0.46%
2/432
|
2.6%
2/76
|
0.81%
1/124
|
|
Vascular disorders
Arteriosclerosis
|
0.46%
2/432
|
1.3%
1/76
|
2.4%
3/124
|
|
Vascular disorders
Hypertension
|
12.7%
55/432
|
30.3%
23/76
|
31.5%
39/124
|
|
Vascular disorders
Hypotension
|
3.0%
13/432
|
6.6%
5/76
|
4.0%
5/124
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER