Trial Outcomes & Findings for Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan (NCT NCT03439137)
NCT ID: NCT03439137
Last Updated: 2023-12-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
323 participants
Primary outcome timeframe
Up to Week 24
Results posted on
2023-12-28
Participant Flow
Participant milestones
| Measure |
MT-6548
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Darbepoetin alfa matching placebo: Intravenous administration
|
Darbepoetin Alfa
Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
MT-6548-matching placebo: Oral tablet
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
161
|
|
Overall Study
COMPLETED
|
120
|
135
|
|
Overall Study
NOT COMPLETED
|
42
|
26
|
Reasons for withdrawal
| Measure |
MT-6548
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Darbepoetin alfa matching placebo: Intravenous administration
|
Darbepoetin Alfa
Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
MT-6548-matching placebo: Oral tablet
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
12
|
|
Overall Study
Physician Decision
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
14
|
4
|
|
Overall Study
Conducting rescue therapy
|
2
|
1
|
|
Overall Study
Difficult to control Hb
|
10
|
2
|
|
Overall Study
Initiation of a renal transplant
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
Baseline characteristics by cohort
| Measure |
MT-6548
n=162 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Darbepoetin alfa matching placebo: Intravenous administration
|
Darbepoetin Alfa
n=161 Participants
Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
MT-6548-matching placebo: Oral tablet
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
101 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
162 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Other)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: This analysis was performed in subjects who measured Hb at least one visit after baseline.
Outcome measures
| Measure |
MT-6548
n=160 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Darbepoetin alfa matching placebo: Intravenous administration
|
Darbepoetin Alfa
n=160 Participants
Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
MT-6548-matching placebo: Oral tablet
|
|---|---|---|
|
Mean Hb Level of Week 20 and Week 24
|
10.61 g/dL
Interval 10.45 to 10.76
|
10.65 g/dL
Interval 10.5 to 10.8
|
SECONDARY outcome
Timeframe: Up to Week 52Population: This analysis was performed in subjects who measured Hb at least one visit after baseline.
Outcome measures
| Measure |
MT-6548
n=160 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Darbepoetin alfa matching placebo: Intravenous administration
|
Darbepoetin Alfa
n=160 Participants
Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
MT-6548-matching placebo: Oral tablet
|
|---|---|---|
|
Mean Hb Level of Week 48 and Week 52
|
10.42 g/dL
Interval 10.27 to 10.56
|
10.62 g/dL
Interval 10.49 to 10.76
|
SECONDARY outcome
Timeframe: Up to Week 52Population: This analysis was performed only in subjects who have Hb data at each visit.
Outcome measures
| Measure |
MT-6548
n=162 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Darbepoetin alfa matching placebo: Intravenous administration
|
Darbepoetin Alfa
n=161 Participants
Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
MT-6548-matching placebo: Oral tablet
|
|---|---|---|
|
Hb Level at Each Assessment Time Point
Baseline
|
10.73 g/dL
Interval 10.62 to 10.85
|
10.73 g/dL
Interval 10.62 to 10.84
|
|
Hb Level at Each Assessment Time Point
Week 2
|
10.61 g/dL
Interval 10.49 to 10.73
|
10.85 g/dL
Interval 10.73 to 10.96
|
|
Hb Level at Each Assessment Time Point
Week 4
|
10.38 g/dL
Interval 10.24 to 10.52
|
10.88 g/dL
Interval 10.77 to 10.99
|
|
Hb Level at Each Assessment Time Point
Week 6
|
10.24 g/dL
Interval 10.09 to 10.4
|
10.83 g/dL
Interval 10.72 to 10.94
|
|
Hb Level at Each Assessment Time Point
Week 8
|
10.24 g/dL
Interval 10.08 to 10.4
|
10.84 g/dL
Interval 10.74 to 10.95
|
|
Hb Level at Each Assessment Time Point
Week 10
|
10.24 g/dL
Interval 10.06 to 10.41
|
10.86 g/dL
Interval 10.75 to 10.98
|
|
Hb Level at Each Assessment Time Point
Week 12
|
10.43 g/dL
Interval 10.25 to 10.61
|
10.90 g/dL
Interval 10.79 to 11.01
|
|
Hb Level at Each Assessment Time Point
Week 16
|
10.57 g/dL
Interval 10.41 to 10.73
|
10.80 g/dL
Interval 10.68 to 10.92
|
|
Hb Level at Each Assessment Time Point
Week 20
|
10.69 g/dL
Interval 10.54 to 10.84
|
10.65 g/dL
Interval 10.52 to 10.78
|
|
Hb Level at Each Assessment Time Point
Week 24
|
10.65 g/dL
Interval 10.5 to 10.81
|
10.63 g/dL
Interval 10.5 to 10.75
|
|
Hb Level at Each Assessment Time Point
Week 28
|
10.58 g/dL
Interval 10.42 to 10.75
|
10.66 g/dL
Interval 10.54 to 10.78
|
|
Hb Level at Each Assessment Time Point
Week 32
|
10.60 g/dL
Interval 10.43 to 10.76
|
10.77 g/dL
Interval 10.64 to 10.89
|
|
Hb Level at Each Assessment Time Point
Week 36
|
10.49 g/dL
Interval 10.32 to 10.66
|
10.75 g/dL
Interval 10.61 to 10.88
|
|
Hb Level at Each Assessment Time Point
Week 40
|
10.53 g/dL
Interval 10.37 to 10.68
|
10.67 g/dL
Interval 10.56 to 10.79
|
|
Hb Level at Each Assessment Time Point
Week 44
|
10.54 g/dL
Interval 10.38 to 10.71
|
10.64 g/dL
Interval 10.52 to 10.76
|
|
Hb Level at Each Assessment Time Point
Week 48
|
10.50 g/dL
Interval 10.33 to 10.66
|
10.63 g/dL
Interval 10.5 to 10.75
|
|
Hb Level at Each Assessment Time Point
Week 52
|
10.47 g/dL
Interval 10.3 to 10.63
|
10.63 g/dL
Interval 10.52 to 10.74
|
|
Hb Level at Each Assessment Time Point
Week 52 (LOCF)
|
10.24 g/dL
Interval 10.08 to 10.41
|
10.61 g/dL
Interval 10.49 to 10.73
|
SECONDARY outcome
Timeframe: Up to Week 52Population: This analysis was performed only in subjects who have Hb data at each visit.
Outcome measures
| Measure |
MT-6548
n=162 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Darbepoetin alfa matching placebo: Intravenous administration
|
Darbepoetin Alfa
n=161 Participants
Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
MT-6548-matching placebo: Oral tablet
|
|---|---|---|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Baseline
|
81.5 percentage of subjects
|
78.9 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 2
|
75.0 percentage of subjects
|
81.3 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 4
|
63.7 percentage of subjects
|
83.0 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 6
|
58.1 percentage of subjects
|
84.3 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 8
|
56.0 percentage of subjects
|
85.4 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 10
|
56.7 percentage of subjects
|
81.5 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 12
|
61.9 percentage of subjects
|
86.6 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 16
|
68.8 percentage of subjects
|
84.6 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 20
|
73.6 percentage of subjects
|
74.0 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 24
|
75.4 percentage of subjects
|
75.7 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 28
|
70.5 percentage of subjects
|
77.3 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 32
|
73.3 percentage of subjects
|
79.5 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 36
|
67.5 percentage of subjects
|
78.9 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 40
|
77.0 percentage of subjects
|
81.6 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 44
|
74.6 percentage of subjects
|
85.6 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 48
|
72.9 percentage of subjects
|
79.7 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 52
|
75.7 percentage of subjects
|
86.5 percentage of subjects
|
Adverse Events
MT-6548
Serious events: 41 serious events
Other events: 130 other events
Deaths: 2 deaths
Darbepoetin Alfa
Serious events: 44 serious events
Other events: 131 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MT-6548
n=162 participants at risk
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Darbepoetin alfa matching placebo: Intravenous administration
|
Darbepoetin Alfa
n=161 participants at risk
Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
MT-6548-matching placebo: Oral tablet
|
|---|---|---|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.62%
1/162 • 52 weeks
|
1.9%
3/161 • 52 weeks
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
2/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Cardiac disorders
Coronary artery perforation
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Cardiac disorders
Coronary artery stenosis
|
0.62%
1/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.62%
1/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Eye disorders
Retinal detachment
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.62%
1/162 • 52 weeks
|
1.2%
2/161 • 52 weeks
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Hepatobiliary disorders
Cholangitis
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Infections and infestations
Bacterial infection
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Infections and infestations
Device related infection
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
1.2%
2/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Infections and infestations
Hepatic cyst infection
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Infections and infestations
Hydrocele male infected
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Infections and infestations
Influenza
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Infections and infestations
Mycotic endophthalmitis
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
1.9%
3/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Infections and infestations
Shunt infection
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.62%
1/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Haemodialysis complication
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Shunt blood flow excessive
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
2.5%
4/162 • 52 weeks
|
1.9%
3/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
2.5%
4/162 • 52 weeks
|
2.5%
4/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.2%
2/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.62%
1/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.62%
1/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal papilloma
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral neoplasm
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.62%
1/162 • 52 weeks
|
1.9%
3/161 • 52 weeks
|
|
Nervous system disorders
Facial paralysis
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Nervous system disorders
Intracranial aneurysm
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Nervous system disorders
Myelopathy
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.62%
1/162 • 52 weeks
|
0.00%
0/161 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Surgical and medical procedures
Renal transplant
|
0.00%
0/162 • 52 weeks
|
1.2%
2/161 • 52 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.2%
2/162 • 52 weeks
|
1.2%
2/161 • 52 weeks
|
|
Vascular disorders
Peripheral artery aneurysm rupture
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
Other adverse events
| Measure |
MT-6548
n=162 participants at risk
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Darbepoetin alfa matching placebo: Intravenous administration
|
Darbepoetin Alfa
n=161 participants at risk
Darbepoetin alfa: Intravenous administration. The dose was adjusted to 5-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
MT-6548-matching placebo: Oral tablet
|
|---|---|---|
|
Eye disorders
Retinal haemorrhage
|
9.9%
16/162 • 52 weeks
|
6.2%
10/161 • 52 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.3%
7/162 • 52 weeks
|
7.5%
12/161 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
25/162 • 52 weeks
|
14.9%
24/161 • 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.2%
10/162 • 52 weeks
|
1.2%
2/161 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
10/162 • 52 weeks
|
10.6%
17/161 • 52 weeks
|
|
Immune system disorders
Seasonal allergy
|
2.5%
4/162 • 52 weeks
|
7.5%
12/161 • 52 weeks
|
|
Infections and infestations
Conjunctivitis
|
6.8%
11/162 • 52 weeks
|
2.5%
4/161 • 52 weeks
|
|
Infections and infestations
Gastroenteritis
|
6.2%
10/162 • 52 weeks
|
0.62%
1/161 • 52 weeks
|
|
Infections and infestations
Influenza
|
4.9%
8/162 • 52 weeks
|
7.5%
12/161 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
45.7%
74/162 • 52 weeks
|
45.3%
73/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
13.0%
21/162 • 52 weeks
|
11.8%
19/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
12.3%
20/162 • 52 weeks
|
14.9%
24/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.6%
9/162 • 52 weeks
|
9.3%
15/161 • 52 weeks
|
|
Injury, poisoning and procedural complications
Wound
|
6.2%
10/162 • 52 weeks
|
4.3%
7/161 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
10/162 • 52 weeks
|
6.8%
11/161 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
15/162 • 52 weeks
|
6.8%
11/161 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
9/162 • 52 weeks
|
3.1%
5/161 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
13/162 • 52 weeks
|
2.5%
4/161 • 52 weeks
|
|
Nervous system disorders
Headache
|
8.0%
13/162 • 52 weeks
|
3.1%
5/161 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.2%
10/162 • 52 weeks
|
5.0%
8/161 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.4%
12/162 • 52 weeks
|
5.6%
9/161 • 52 weeks
|
Additional Information
Clinical Trials, Information Desk
Mitsubishi Tanabe Pharma Corporation
Phone: +81-3-5960-9608 Japanese only
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER