A Phase III, Multicentre, Double-Blind, Placebo-Controlle... | NCT00416520

NCT00416520

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)
2	Placebo Comparator	Drug: Placebo
3	Active Comparator	Drug: Another phosphate binder (Sevelamer)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)	Drug	3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)	ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.	week16 minus week12

Secondary Outcomes

Measure	Description	Time Frame
Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)	ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.	week12 minus week0

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Professor	Information at Mitsubishi Pharma Europe	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40576086	Derived	Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	MCI-196 (Open-label Period)	3, 6, 9, 12, or 15g/day as titrated There was a gap of 3 subjects between "STARTED" and "Overall Number of Baseline Participants". Two subjects were randomised to receive MCI-196, but did not take study medication. These 2 subjects were excluded from "Baseline Participants" of MCI-196 group. In addition, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for "STARTED" but counted as Sevelamer group for "Baseline Participants".

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-0.24± 1.46 OG0011.27± 1.48

Secondary

Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)

ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.

Posted

Mean

Standard Deviation

mg / dL

week12 minus week0

ID	Title	Description
OG000	MCI-196 (Open-label Period)	3, 6, 9, 12, or 15g/day as titrated
OG001	Sevelamer (Open-label Period)	2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MCI-196 (Open-label Period)	3, 6, 9, 12, or 15g/day as titrated	26	162	126	162
EG001	Sevelamer (Open-label Period)	2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated	25	169	113	169
EG002	MCI-196 (Placebo-Controlled Period)	dose level at the end of dose titration in the flexible dose period	2	50	20	50
EG003	Placebo (Placebo-Controlled Period)	dose level at the end of dose titration in the flexible dose period	3	53	23	53

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0002 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG0031 affected53 at risk
Acute coronary syndrome	Cardiac disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Angina pectoris	Cardiac disorders	EG0001 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Atrial fibrillation	Cardiac disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Atrioventricular block complete	Cardiac disorders	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Cardiac arrest	Cardiac disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Cardiovascular insufficiency	Cardiac disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Coronary artery disease	Cardiac disorders	EG0001 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Coronary artery insufficiency	Cardiac disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Coronary artery stenosis	Cardiac disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Myocardial infarction	Cardiac disorders	EG0003 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Haemorrhoids	Gastrointestinal disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Nausea	Gastrointestinal disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Peritonitis	Gastrointestinal disorders	EG0001 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Vomiting	Gastrointestinal disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Hernia	General disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Impaired healing	General disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Pyrexia	General disorders	EG0001 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Biliary colic	Hepatobiliary disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Cholelithiasis	Hepatobiliary disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Anaphylactic reaction	Immune system disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Bronchopneumonia	Infections and infestations	EG0000 affected162 at risk EG0011 affected169 at risk EG0021 affected50 at risk EG003
Catheter sepsis	Infections and infestations	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Cellulitis	Infections and infestations	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Diverticulitis	Infections and infestations	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Fungal infection	Infections and infestations	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Pyelonephritis acute	Infections and infestations	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Septic shock	Infections and infestations	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Urinary tract infection	Infections and infestations	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	EG0002 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Arteriogram coronary	Investigations	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Hepatic enzyme increased	Investigations	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Fluid overload	Metabolism and nutrition disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Fluid retention	Metabolism and nutrition disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Carotid artery stenosis	Nervous system disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Cerebrovascular disorder	Nervous system disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Genital haemorrhage	Reproductive system and breast disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Testicular pain	Reproductive system and breast disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Cataract operation	Surgical and medical procedures	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Coronary arterial stent insertion	Surgical and medical procedures	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Renal transplant	Surgical and medical procedures	EG0001 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Toe amputation	Surgical and medical procedures	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Circulatory collapse	Vascular disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Hypovolaemic shock	Vascular disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Peripheral vascular disorder	Vascular disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Pneumonia	Infections and infestations	EG0000 affected162 at risk EG0010 affected169 at risk EG0021 affected50 at risk EG003
Dialysis device complication	Injury, poisoning and procedural complications	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	EG0000 affected162 at risk EG0010 affected169 at risk EG0021 affected50 at risk EG003

Other Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0006 affected162 at risk EG0016 affected169 at risk EG0020 affected50 at risk EG0032 affected53 at risk
Angina pectoris	Cardiac disorders	EG0002 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Hyperparathyroidism	Endocrine disorders	EG0002 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Hyperparathyroidism secondary	Endocrine disorders	EG0002 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Eye haemorrhage	Eye disorders	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Abdominal distension	Gastrointestinal disorders	EG0001 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Abdominal pain	Gastrointestinal disorders	EG0008 affected162 at risk EG0014 affected169 at risk EG0020 affected50 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	EG00010 affected162 at risk EG0018 affected169 at risk EG0021 affected50 at risk EG003
Constipation	Gastrointestinal disorders	EG00013 affected162 at risk EG00111 affected169 at risk EG0022 affected50 at risk EG003
Diarrhoea	Gastrointestinal disorders	EG00021 affected162 at risk EG00116 affected169 at risk EG0022 affected50 at risk EG003
Duodenitis	Gastrointestinal disorders	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Dyspepsia	Gastrointestinal disorders	EG00013 affected162 at risk EG0016 affected169 at risk EG0020 affected50 at risk EG003
Eructation	Gastrointestinal disorders	EG0001 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Faeces discoloured	Gastrointestinal disorders	EG0002 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Flatulence	Gastrointestinal disorders	EG0004 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	EG0003 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Gastritis	Gastrointestinal disorders	EG0002 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Haemorrhoids	Gastrointestinal disorders	EG0001 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Nausea	Gastrointestinal disorders	EG00015 affected162 at risk EG00112 affected169 at risk EG0020 affected50 at risk EG003
Vomiting	Gastrointestinal disorders	EG00027 affected162 at risk EG0019 affected169 at risk EG0021 affected50 at risk EG003
Asthenia	General disorders	EG0002 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Catheter site erythema	General disorders	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Catheter site pain	General disorders	EG0002 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Chest pain	General disorders	EG0002 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Fatigue	General disorders	EG0002 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Non-cardiac chest pain	General disorders	EG0002 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Oedema peripheral	General disorders	EG0002 affected162 at risk EG0011 affected169 at risk EG0022 affected50 at risk EG003
Pyrexia	General disorders	EG0005 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Bronchitis	Infections and infestations	EG0005 affected162 at risk EG0013 affected169 at risk EG0022 affected50 at risk EG003
Bronchopneumonia	Infections and infestations	EG0002 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Cellulitis	Infections and infestations	EG0001 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Cystitis	Infections and infestations	EG0000 affected162 at risk EG0013 affected169 at risk EG0020 affected50 at risk EG003
Gastroenteritis	Infections and infestations	EG0000 affected162 at risk EG0012 affected169 at risk EG0021 affected50 at risk EG003
Influenza	Infections and infestations	EG0001 affected162 at risk EG0014 affected169 at risk EG0020 affected50 at risk EG003
Nasopharyngitis	Infections and infestations	EG0008 affected162 at risk EG0017 affected169 at risk EG0020 affected50 at risk EG003
Pharyngitis	Infections and infestations	EG0001 affected162 at risk EG0015 affected169 at risk EG0020 affected50 at risk EG003
Respiratory tract infection	Infections and infestations	EG0002 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Upper respiratory tract infection	Infections and infestations	EG0004 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Urinary tract infection	Infections and infestations	EG0002 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	EG0004 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	EG0002 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Haemodialysis-induced symptom	Injury, poisoning and procedural complications	EG0006 affected162 at risk EG0019 affected169 at risk EG0023 affected50 at risk EG003
Limb injury	Injury, poisoning and procedural complications	EG0001 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Procedural hypertension	Injury, poisoning and procedural complications	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Procedural hypotension	Injury, poisoning and procedural complications	EG0003 affected162 at risk EG0017 affected169 at risk EG0020 affected50 at risk EG003
Blood parathyroid hormone increased	Investigations	EG0001 affected162 at risk EG0013 affected169 at risk EG0021 affected50 at risk EG003
C-reactive protein increased	Investigations	EG0002 affected162 at risk EG0012 affected169 at risk EG0021 affected50 at risk EG003
Electrocardiogram QT interval abnormal	Investigations	EG0003 affected162 at risk EG0010 affected169 at risk EG0021 affected50 at risk EG003
Haemoglobin decreased	Investigations	EG0001 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	EG0003 affected162 at risk EG0013 affected169 at risk EG0020 affected50 at risk EG003
Fluid overload	Metabolism and nutrition disorders	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Fluid retention	Metabolism and nutrition disorders	EG0002 affected162 at risk EG0011 affected169 at risk EG0022 affected50 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	EG0001 affected162 at risk EG0012 affected169 at risk EG0021 affected50 at risk EG003
Hyperphosphataemia	Metabolism and nutrition disorders	EG0002 affected162 at risk EG0010 affected169 at risk EG0021 affected50 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	EG0008 affected162 at risk EG0016 affected169 at risk EG0021 affected50 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	EG0001 affected162 at risk EG0012 affected169 at risk EG0022 affected50 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	EG0005 affected162 at risk EG0014 affected169 at risk EG0021 affected50 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	EG0005 affected162 at risk EG0014 affected169 at risk EG0021 affected50 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	EG0005 affected162 at risk EG0011 affected169 at risk EG0021 affected50 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	EG0005 affected162 at risk EG0015 affected169 at risk EG0021 affected50 at risk EG003
Headache	Nervous system disorders	EG0006 affected162 at risk EG0015 affected169 at risk EG0021 affected50 at risk EG003
Hypotonia	Nervous system disorders	EG0001 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Anxiety	Psychiatric disorders	EG0002 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Insomnia	Psychiatric disorders	EG0001 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Sleep disorder	Psychiatric disorders	EG0002 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	EG0005 affected162 at risk EG0015 affected169 at risk EG0020 affected50 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0003 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	EG0001 affected162 at risk EG0013 affected169 at risk EG0021 affected50 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	EG0000 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	EG0005 affected162 at risk EG0015 affected169 at risk EG0020 affected50 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	EG0001 affected162 at risk EG0012 affected169 at risk EG0020 affected50 at risk EG003
Renal transplant	Surgical and medical procedures	EG0002 affected162 at risk EG0014 affected169 at risk EG0020 affected50 at risk EG003
Hypertension	Vascular disorders	EG00012 affected162 at risk EG00112 affected169 at risk EG0021 affected50 at risk EG003
Hypotension	Vascular disorders	EG0001 affected162 at risk EG0016 affected169 at risk EG0020 affected50 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	EG0000 affected162 at risk EG0010 affected169 at risk EG0021 affected50 at risk EG003
Spontaneous haematoma	Blood and lymphatic system disorders	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Cardiac failure	Cardiac disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0021 affected50 at risk EG003
Sinus bradycardia	Cardiac disorders	EG0000 affected162 at risk EG0010 affected169 at risk EG0021 affected50 at risk EG003
Toothache	Gastrointestinal disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0021 affected50 at risk EG003
Bacteraemia	Infections and infestations	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Catheter site infection	Infections and infestations	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Rhinitis	Infections and infestations	EG0000 affected162 at risk EG0011 affected169 at risk EG0022 affected50 at risk EG003
Tonsillitis	Infections and infestations	EG0000 affected162 at risk EG0010 affected169 at risk EG0021 affected50 at risk EG003
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Eschar	Injury, poisoning and procedural complications	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Blood phosphorus decreased	Investigations	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Gamma-glutamyltransferase increased	Investigations	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Vitamin D decreased	Investigations	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Weight increased	Investigations	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Acidosis	Metabolism and nutrition disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	EG0001 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Restless legs syndrome	Nervous system disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Haematuria	Renal and urinary disorders	EG0001 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	EG0000 affected162 at risk EG0011 affected169 at risk EG0020 affected50 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	EG0000 affected162 at risk EG0010 affected169 at risk EG0020 affected50 at risk EG003

ID	Term
D051436	Renal Insufficiency, Chronic
D054559	Hyperphosphatemia

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C106574	cholebine
D000069603	Sevelamer

Facility	Status	City	State	ZIP	Country	Contacts
		Adelaide			Australia

ID	Term
D011073	Polyamines
D000588	Amines
D009930	Organic Chemicals

ID	Title	Description
BG000	MCI-196 (Open-label Period)
BG001	Sevelamer (Open-label Period)
BG002	Total	Total of all reporting groups