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Trial Outcomes & Findings for A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia (NCT NCT00416520)

NCT ID: NCT00416520

Last Updated: 2026-01-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

336 participants

Primary outcome timeframe

week16 minus week12

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure
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".
Sevelamer (Open-label Period)
2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated * There was a gap of 2 subjects between "STARTED" and "Overall Number of Baseline Participants". * Three subjects in Sevelamer group were randomised in error and did not take any study medication. These 3 subjects were excluded from "Baseline Participants" of Sevelamer group. * However, 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".
MCI-196 (Placebo-controlled Withdrawal Period)
dose level at the end of dose titration in the flexible dose period
Placebo (Placebo-controlled Withdrawal Period)
dose level at the end of dose titration in the flexible dose period There was a gap of 1 subject between "STARTED" and "Overall Number of Baseline Participants" One subject did not take any study medication and excluded from "Baseline Participants".
Open-label Period
STARTED
165
171
0
0
Open-label Period
COMPLETED
105
139
0
0
Open-label Period
NOT COMPLETED
60
32
0
0
Placebo-controlled Withdrawal Period
STARTED
0
0
50
54
Placebo-controlled Withdrawal Period
COMPLETED
0
0
49
49
Placebo-controlled Withdrawal Period
NOT COMPLETED
0
0
1
5

Reasons for withdrawal

Reasons for withdrawal
Measure
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".
Sevelamer (Open-label Period)
2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated * There was a gap of 2 subjects between "STARTED" and "Overall Number of Baseline Participants". * Three subjects in Sevelamer group were randomised in error and did not take any study medication. These 3 subjects were excluded from "Baseline Participants" of Sevelamer group. * However, 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".
MCI-196 (Placebo-controlled Withdrawal Period)
dose level at the end of dose titration in the flexible dose period
Placebo (Placebo-controlled Withdrawal Period)
dose level at the end of dose titration in the flexible dose period There was a gap of 1 subject between "STARTED" and "Overall Number of Baseline Participants" One subject did not take any study medication and excluded from "Baseline Participants".
Open-label Period
Adverse Event
28
10
0
0
Open-label Period
Death
2
1
0
0
Open-label Period
Lack of Efficacy
8
1
0
0
Open-label Period
Protocol Violation
3
3
0
0
Open-label Period
Withdrawal by Subject
16
5
0
0
Open-label Period
Other Reasons
3
12
0
0
Placebo-controlled Withdrawal Period
Adverse Event
0
0
0
1
Placebo-controlled Withdrawal Period
Lack of Efficacy
0
0
0
3
Placebo-controlled Withdrawal Period
Protocol Violation
0
0
1
1

Baseline Characteristics

A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MCI-196 (Open-label Period)
n=162 Participants
Sevelamer (Open-label Period)
n=169 Participants
Total
n=331 Participants
Total of all reporting groups
Age, Continuous
56.4 years
STANDARD_DEVIATION 14.7 • n=18 Participants
59.5 years
STANDARD_DEVIATION 13.8 • n=17 Participants
58.0 years
STANDARD_DEVIATION 14.3 • n=35 Participants
Sex: Female, Male
Female
54 Participants
n=18 Participants
72 Participants
n=17 Participants
126 Participants
n=35 Participants
Sex: Female, Male
Male
108 Participants
n=18 Participants
97 Participants
n=17 Participants
205 Participants
n=35 Participants

PRIMARY outcome

Timeframe: week16 minus week12

Population: 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.

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.

Outcome measures

Outcome measures
Measure
MCI-196 (Placebo-controlled Withdrawal Period)
n=50 Participants
dose level at the end of dose titration in the flexible dose period
Placebo (Placebo-controlled Withdrawal Period)
n=53 Participants
dose level at the end of dose titration in the flexible dose period
Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
-0.24 mg / dL
Standard Deviation 1.46
1.27 mg / dL
Standard Deviation 1.48

SECONDARY outcome

Timeframe: week12 minus week0

Population: 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.

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.

Outcome measures

Outcome measures
Measure
MCI-196 (Placebo-controlled Withdrawal Period)
n=160 Participants
dose level at the end of dose titration in the flexible dose period
Placebo (Placebo-controlled Withdrawal Period)
n=167 Participants
dose level at the end of dose titration in the flexible dose period
Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)
-1.12 mg / dL
Standard Deviation 1.63
-2.16 mg / dL
Standard Deviation 1.55

Adverse Events

MCI-196 (Open-label Period)

Serious events: 26 serious events
Other events: 126 other events
Deaths: 0 deaths

Sevelamer (Open-label Period)

Serious events: 25 serious events
Other events: 113 other events
Deaths: 0 deaths

MCI-196 (Placebo-Controlled Period)

Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths

Placebo (Placebo-Controlled Period)

Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
MCI-196 (Open-label Period)
n=162 participants at risk
3, 6, 9, 12, or 15g/day as titrated
Sevelamer (Open-label Period)
n=169 participants at risk
2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
MCI-196 (Placebo-Controlled Period)
n=50 participants at risk
dose level at the end of dose titration in the flexible dose period
Placebo (Placebo-Controlled Period)
n=53 participants at risk
dose level at the end of dose titration in the flexible dose period
Blood and lymphatic system disorders
Anaemia
1.2%
2/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Cardiac disorders
Acute coronary syndrome
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Angina pectoris
0.62%
1/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Atrial fibrillation
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Atrioventricular block complete
0.00%
0/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Cardiac arrest
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Cardiovascular insufficiency
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Congestive cardiomyopathy
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Coronary artery disease
0.62%
1/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Coronary artery insufficiency
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Coronary artery stenosis
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Ischaemic cardiomyopathy
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Cardiac disorders
Myocardial infarction
1.9%
3/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Diverticulum intestinal
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Duodenal ulcer haemorrhage
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Haemorrhoids
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Nausea
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Peritonitis
0.62%
1/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Vomiting
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
General disorders
Hernia
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
General disorders
Impaired healing
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
General disorders
Pyrexia
0.62%
1/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Hepatobiliary disorders
Biliary colic
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Hepatobiliary disorders
Cholelithiasis
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Immune system disorders
Anaphylactic reaction
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Bronchopneumonia
0.00%
0/162
0.59%
1/169
2.0%
1/50
0.00%
0/53
Infections and infestations
Catheter sepsis
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Cellulitis
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Diverticulitis
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Fungal infection
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Pyelonephritis acute
0.62%
1/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Infections and infestations
Septic shock
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Urinary tract infection
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
1.2%
2/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Investigations
Arteriogram coronary
0.00%
0/162
1.2%
2/169
0.00%
0/50
1.9%
1/53
Investigations
Hepatic enzyme increased
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Metabolism and nutrition disorders
Fluid overload
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Metabolism and nutrition disorders
Fluid retention
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Nervous system disorders
Carotid artery stenosis
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Nervous system disorders
Cerebrovascular disorder
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Reproductive system and breast disorders
Genital haemorrhage
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Reproductive system and breast disorders
Testicular pain
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Surgical and medical procedures
Cataract operation
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Surgical and medical procedures
Coronary arterial stent insertion
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Surgical and medical procedures
Renal transplant
0.62%
1/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Surgical and medical procedures
Toe amputation
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Vascular disorders
Circulatory collapse
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Vascular disorders
Hypovolaemic shock
0.62%
1/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Vascular disorders
Peripheral vascular disorder
0.00%
0/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Pneumonia
0.00%
0/162
0.00%
0/169
2.0%
1/50
0.00%
0/53
Injury, poisoning and procedural complications
Dialysis device complication
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.00%
0/162
0.00%
0/169
2.0%
1/50
0.00%
0/53

Other adverse events

Other adverse events
Measure
MCI-196 (Open-label Period)
n=162 participants at risk
3, 6, 9, 12, or 15g/day as titrated
Sevelamer (Open-label Period)
n=169 participants at risk
2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
MCI-196 (Placebo-Controlled Period)
n=50 participants at risk
dose level at the end of dose titration in the flexible dose period
Placebo (Placebo-Controlled Period)
n=53 participants at risk
dose level at the end of dose titration in the flexible dose period
Blood and lymphatic system disorders
Anaemia
3.7%
6/162
3.6%
6/169
0.00%
0/50
3.8%
2/53
Cardiac disorders
Angina pectoris
1.2%
2/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Endocrine disorders
Hyperparathyroidism
1.2%
2/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Endocrine disorders
Hyperparathyroidism secondary
1.2%
2/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Eye disorders
Eye haemorrhage
0.00%
0/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Abdominal distension
0.62%
1/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Abdominal pain
4.9%
8/162
2.4%
4/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Abdominal pain upper
6.2%
10/162
4.7%
8/169
2.0%
1/50
0.00%
0/53
Gastrointestinal disorders
Constipation
8.0%
13/162
6.5%
11/169
4.0%
2/50
0.00%
0/53
Gastrointestinal disorders
Diarrhoea
13.0%
21/162
9.5%
16/169
4.0%
2/50
1.9%
1/53
Gastrointestinal disorders
Duodenitis
0.00%
0/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Dyspepsia
8.0%
13/162
3.6%
6/169
0.00%
0/50
1.9%
1/53
Gastrointestinal disorders
Eructation
0.62%
1/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Faeces discoloured
1.2%
2/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Flatulence
2.5%
4/162
1.2%
2/169
0.00%
0/50
1.9%
1/53
Gastrointestinal disorders
Frequent bowel movements
1.9%
3/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Gastritis
1.2%
2/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Haemorrhoids
0.62%
1/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Gastrointestinal disorders
Nausea
9.3%
15/162
7.1%
12/169
0.00%
0/50
1.9%
1/53
Gastrointestinal disorders
Vomiting
16.7%
27/162
5.3%
9/169
2.0%
1/50
0.00%
0/53
General disorders
Asthenia
1.2%
2/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
General disorders
Catheter site erythema
0.00%
0/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
General disorders
Catheter site pain
1.2%
2/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
General disorders
Chest pain
1.2%
2/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
General disorders
Fatigue
1.2%
2/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
General disorders
Non-cardiac chest pain
1.2%
2/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
General disorders
Oedema peripheral
1.2%
2/162
0.59%
1/169
4.0%
2/50
0.00%
0/53
General disorders
Pyrexia
3.1%
5/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Bronchitis
3.1%
5/162
1.8%
3/169
4.0%
2/50
1.9%
1/53
Infections and infestations
Bronchopneumonia
1.2%
2/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Cellulitis
0.62%
1/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Cystitis
0.00%
0/162
1.8%
3/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Gastroenteritis
0.00%
0/162
1.2%
2/169
2.0%
1/50
0.00%
0/53
Infections and infestations
Influenza
0.62%
1/162
2.4%
4/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Nasopharyngitis
4.9%
8/162
4.1%
7/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Pharyngitis
0.62%
1/162
3.0%
5/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Respiratory tract infection
1.2%
2/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Upper respiratory tract infection
2.5%
4/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Infections and infestations
Urinary tract infection
1.2%
2/162
0.59%
1/169
0.00%
0/50
0.00%
0/53
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
2.5%
4/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
1.2%
2/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Injury, poisoning and procedural complications
Haemodialysis-induced symptom
3.7%
6/162
5.3%
9/169
6.0%
3/50
0.00%
0/53
Injury, poisoning and procedural complications
Limb injury
0.62%
1/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Injury, poisoning and procedural complications
Procedural hypertension
0.00%
0/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Injury, poisoning and procedural complications
Procedural hypotension
1.9%
3/162
4.1%
7/169
0.00%
0/50
0.00%
0/53
Investigations
Blood parathyroid hormone increased
0.62%
1/162
1.8%
3/169
2.0%
1/50
0.00%
0/53
Investigations
C-reactive protein increased
1.2%
2/162
1.2%
2/169
2.0%
1/50
1.9%
1/53
Investigations
Electrocardiogram QT interval abnormal
1.9%
3/162
0.00%
0/169
2.0%
1/50
0.00%
0/53
Investigations
Haemoglobin decreased
0.62%
1/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Metabolism and nutrition disorders
Decreased appetite
1.9%
3/162
1.8%
3/169
0.00%
0/50
0.00%
0/53
Metabolism and nutrition disorders
Fluid overload
0.00%
0/162
1.2%
2/169
0.00%
0/50
1.9%
1/53
Metabolism and nutrition disorders
Fluid retention
1.2%
2/162
0.59%
1/169
4.0%
2/50
0.00%
0/53
Metabolism and nutrition disorders
Hyperkalaemia
0.62%
1/162
1.2%
2/169
2.0%
1/50
0.00%
0/53
Metabolism and nutrition disorders
Hyperphosphataemia
1.2%
2/162
0.00%
0/169
2.0%
1/50
0.00%
0/53
Metabolism and nutrition disorders
Hypocalcaemia
4.9%
8/162
3.6%
6/169
2.0%
1/50
0.00%
0/53
Metabolism and nutrition disorders
Hypoglycaemia
0.62%
1/162
1.2%
2/169
4.0%
2/50
0.00%
0/53
Musculoskeletal and connective tissue disorders
Arthralgia
3.1%
5/162
2.4%
4/169
2.0%
1/50
1.9%
1/53
Musculoskeletal and connective tissue disorders
Back pain
3.1%
5/162
2.4%
4/169
2.0%
1/50
0.00%
0/53
Musculoskeletal and connective tissue disorders
Muscle spasms
3.1%
5/162
0.59%
1/169
2.0%
1/50
1.9%
1/53
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Musculoskeletal and connective tissue disorders
Pain in extremity
3.1%
5/162
3.0%
5/169
2.0%
1/50
0.00%
0/53
Nervous system disorders
Headache
3.7%
6/162
3.0%
5/169
2.0%
1/50
1.9%
1/53
Nervous system disorders
Hypotonia
0.62%
1/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Psychiatric disorders
Anxiety
1.2%
2/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Psychiatric disorders
Insomnia
0.62%
1/162
1.2%
2/169
0.00%
0/50
3.8%
2/53
Psychiatric disorders
Sleep disorder
1.2%
2/162
0.00%
0/169
0.00%
0/50
0.00%
0/53
Respiratory, thoracic and mediastinal disorders
Cough
3.1%
5/162
3.0%
5/169
0.00%
0/50
0.00%
0/53
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.9%
3/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.62%
1/162
1.8%
3/169
2.0%
1/50
0.00%
0/53
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Skin and subcutaneous tissue disorders
Pruritus
3.1%
5/162
3.0%
5/169
0.00%
0/50
0.00%
0/53
Skin and subcutaneous tissue disorders
Skin ulcer
0.62%
1/162
1.2%
2/169
0.00%
0/50
0.00%
0/53
Surgical and medical procedures
Renal transplant
1.2%
2/162
2.4%
4/169
0.00%
0/50
0.00%
0/53
Vascular disorders
Hypertension
7.4%
12/162
7.1%
12/169
2.0%
1/50
1.9%
1/53
Vascular disorders
Hypotension
0.62%
1/162
3.6%
6/169
0.00%
0/50
1.9%
1/53
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/162
0.00%
0/169
2.0%
1/50
0.00%
0/53
Blood and lymphatic system disorders
Spontaneous haematoma
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Cardiac disorders
Cardiac failure
0.00%
0/162
0.59%
1/169
2.0%
1/50
0.00%
0/53
Cardiac disorders
Sinus bradycardia
0.00%
0/162
0.00%
0/169
2.0%
1/50
0.00%
0/53
Gastrointestinal disorders
Toothache
0.00%
0/162
0.59%
1/169
2.0%
1/50
0.00%
0/53
Infections and infestations
Bacteraemia
0.00%
0/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Infections and infestations
Catheter site infection
0.00%
0/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Infections and infestations
Rhinitis
0.00%
0/162
0.59%
1/169
4.0%
2/50
0.00%
0/53
Infections and infestations
Tonsillitis
0.00%
0/162
0.00%
0/169
2.0%
1/50
0.00%
0/53
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Injury, poisoning and procedural complications
Eschar
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Investigations
Blood phosphorus decreased
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Investigations
Gamma-glutamyltransferase increased
0.62%
1/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Investigations
Vitamin D decreased
0.00%
0/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Investigations
Weight increased
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Metabolism and nutrition disorders
Acidosis
0.00%
0/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Metabolism and nutrition disorders
Metabolic acidosis
0.62%
1/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.62%
1/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Musculoskeletal and connective tissue disorders
Osteonecrosis
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Nervous system disorders
Restless legs syndrome
0.00%
0/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Renal and urinary disorders
Haematuria
0.62%
1/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/162
0.59%
1/169
0.00%
0/50
1.9%
1/53
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/162
0.00%
0/169
0.00%
0/50
1.9%
1/53

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER