Trial Outcomes & Findings for Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan (NCT NCT03329196)
NCT ID: NCT03329196
Last Updated: 2023-12-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 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
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
153
|
|
Overall Study
COMPLETED
|
111
|
123
|
|
Overall Study
NOT COMPLETED
|
40
|
30
|
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
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
5
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
3
|
|
Overall Study
Hepatic function abnormalities
|
0
|
1
|
|
Overall Study
Conducting rescue therapy before Week 24
|
2
|
1
|
|
Overall Study
Difficult to control Hb
|
2
|
3
|
|
Overall Study
Dialysis or renal transplant
|
13
|
15
|
Baseline Characteristics
Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Baseline characteristics by cohort
| Measure |
MT-6548
n=151 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
Darbepoetin Alfa
n=153 Participants
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
118 Participants
n=93 Participants
|
125 Participants
n=4 Participants
|
243 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
156 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
151 Participants
n=93 Participants
|
153 Participants
n=4 Participants
|
304 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian (Other)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Outcome measures
| Measure |
MT-6548
n=151 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
Darbepoetin Alfa
n=153 Participants
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Mean Hb Level of Week 20 and Week 24
|
11.66 g/dL
Interval 11.49 to 11.84
|
11.93 g/dL
Interval 11.76 to 12.1
|
SECONDARY outcome
Timeframe: Up to Week 52Outcome measures
| Measure |
MT-6548
n=151 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
Darbepoetin Alfa
n=153 Participants
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Mean Hb Level of Week 48 and Week 52
|
11.54 g/dL
Interval 11.38 to 11.69
|
11.63 g/dL
Interval 11.48 to 11.77
|
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=151 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
Darbepoetin Alfa
n=153 Participants
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Hb Level at Each Assessment Time Point
Week 36
|
11.74 g/dL
Interval 11.58 to 11.91
|
11.99 g/dL
Interval 11.84 to 12.15
|
|
Hb Level at Each Assessment Time Point
Baseline
|
10.44 g/dL
Interval 10.29 to 10.59
|
10.52 g/dL
Interval 10.38 to 10.66
|
|
Hb Level at Each Assessment Time Point
Week 2
|
10.64 g/dL
Interval 10.48 to 10.8
|
10.75 g/dL
Interval 10.62 to 10.89
|
|
Hb Level at Each Assessment Time Point
Week 4
|
10.71 g/dL
Interval 10.54 to 10.89
|
10.90 g/dL
Interval 10.76 to 11.05
|
|
Hb Level at Each Assessment Time Point
Week 6
|
10.87 g/dL
Interval 10.69 to 11.04
|
11.23 g/dL
Interval 11.08 to 11.38
|
|
Hb Level at Each Assessment Time Point
Week 8
|
11.13 g/dL
Interval 10.96 to 11.3
|
11.42 g/dL
Interval 11.26 to 11.59
|
|
Hb Level at Each Assessment Time Point
Week 10
|
11.33 g/dL
Interval 11.17 to 11.49
|
11.70 g/dL
Interval 11.54 to 11.85
|
|
Hb Level at Each Assessment Time Point
Week 12
|
11.50 g/dL
Interval 11.34 to 11.67
|
11.88 g/dL
Interval 11.72 to 12.04
|
|
Hb Level at Each Assessment Time Point
Week 16
|
11.56 g/dL
Interval 11.39 to 11.74
|
12.00 g/dL
Interval 11.84 to 12.16
|
|
Hb Level at Each Assessment Time Point
Week 20
|
11.66 g/dL
Interval 11.47 to 11.84
|
11.92 g/dL
Interval 11.77 to 12.06
|
|
Hb Level at Each Assessment Time Point
Week 24
|
11.68 g/dL
Interval 11.49 to 11.87
|
11.94 g/dL
Interval 11.8 to 12.08
|
|
Hb Level at Each Assessment Time Point
Week 28
|
11.72 g/dL
Interval 11.56 to 11.88
|
11.89 g/dL
Interval 11.74 to 12.03
|
|
Hb Level at Each Assessment Time Point
Week 32
|
11.74 g/dL
Interval 11.57 to 11.91
|
11.79 g/dL
Interval 11.66 to 11.92
|
|
Hb Level at Each Assessment Time Point
Week 40
|
11.61 g/dL
Interval 11.46 to 11.76
|
11.78 g/dL
Interval 11.66 to 11.91
|
|
Hb Level at Each Assessment Time Point
Week 44
|
11.50 g/dL
Interval 11.35 to 11.66
|
11.68 g/dL
Interval 11.56 to 11.8
|
|
Hb Level at Each Assessment Time Point
Week 48
|
11.68 g/dL
Interval 11.52 to 11.84
|
11.73 g/dL
Interval 11.59 to 11.87
|
|
Hb Level at Each Assessment Time Point
Week 52
|
11.62 g/dL
Interval 11.47 to 11.77
|
11.64 g/dL
Interval 11.52 to 11.76
|
|
Hb Level at Each Assessment Time Point
Week 52 (LOCF)
|
11.29 g/dL
Interval 11.11 to 11.47
|
11.50 g/dL
Interval 11.34 to 11.65
|
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=151 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
Darbepoetin Alfa
n=153 Participants
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Baseline
|
31.1 percentage of subjects
|
32.7 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 2
|
36.4 percentage of subjects
|
37.9 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 4
|
46.3 percentage of subjects
|
53.3 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 6
|
45.3 percentage of subjects
|
63.8 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 8
|
57.9 percentage of subjects
|
65.6 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 10
|
59.3 percentage of subjects
|
68.0 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 12
|
68.3 percentage of subjects
|
67.6 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 16
|
68.5 percentage of subjects
|
71.6 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 20
|
65.5 percentage of subjects
|
73.6 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 24
|
68.2 percentage of subjects
|
77.9 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 28
|
77.6 percentage of subjects
|
76.6 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 32
|
75.0 percentage of subjects
|
78.8 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 36
|
77.3 percentage of subjects
|
77.5 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 40
|
76.3 percentage of subjects
|
87.4 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 44
|
71.9 percentage of subjects
|
85.5 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 48
|
74.5 percentage of subjects
|
79.8 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 52
|
75.2 percentage of subjects
|
80.3 percentage of subjects
|
SECONDARY outcome
Timeframe: Up to Week 52Population: This analysis was performed in correction group except for subjects with Hb is 11.0 g/dL or more at baseline.
Outcome measures
| Measure |
MT-6548
n=60 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
Darbepoetin Alfa
n=64 Participants
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Time to Reach the Target Hb Range in Correction Group Only
|
43.0 days
Interval 12.0 to 361.0
|
29.0 days
Interval 14.0 to 225.0
|
SECONDARY outcome
Timeframe: Up to Week 6Population: This analysis was performed in subjects of correction group who have Hb up to week 4 or week 6.
Outcome measures
| Measure |
MT-6548
n=69 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
Darbepoetin Alfa
n=70 Participants
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Rate of Increase in Hb Level in Correction Group Only
Calculated based on Hb at baseline and Week 4
|
0.14 g/dL/week
Interval 0.09 to 0.19
|
0.21 g/dL/week
Interval 0.17 to 0.24
|
|
Rate of Increase in Hb Level in Correction Group Only
Calculated based on Hb up to Week6
|
0.13 g/dL/week
Interval 0.09 to 0.17
|
0.21 g/dL/week
Interval 0.18 to 0.25
|
Adverse Events
MT-6548
Serious events: 42 serious events
Other events: 85 other events
Deaths: 0 deaths
Darbepoetin Alfa
Serious events: 49 serious events
Other events: 80 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MT-6548
n=151 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
n=153 participants at risk
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure chronic
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
1.3%
2/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Cardiac disorders
Ventricular tachycardia
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Eye disorders
Cataract
|
2.0%
3/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/151 • 52 weeks
|
1.3%
2/153 • 52 weeks
|
|
Gastrointestinal disorders
Ischaemic enteritis
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.66%
1/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
General disorders
Chest pain
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
General disorders
Oedema peripheral
|
0.66%
1/151 • 52 weeks
|
1.3%
2/153 • 52 weeks
|
|
Hepatobiliary disorders
Bile duct stone
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Infections and infestations
Abscess limb
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Infections and infestations
Cellulitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/151 • 52 weeks
|
1.3%
2/153 • 52 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Infections and infestations
Diverticulitis
|
0.66%
1/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Infections and infestations
Mediastinal abscess
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Infections and infestations
Osteomyelitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Infections and infestations
Periodontitis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
1.3%
2/151 • 52 weeks
|
2.0%
3/153 • 52 weeks
|
|
Infections and infestations
Pneumonia chlamydial
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Infections and infestations
Pyelonephritis acute
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Infections and infestations
Renal cyst infection
|
0.66%
1/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.66%
1/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Seroma
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.3%
2/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/151 • 52 weeks
|
1.3%
2/153 • 52 weeks
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.66%
1/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.66%
1/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Nervous system disorders
Intracranial aneurysm
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Nervous system disorders
Presyncope
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.6%
7/151 • 52 weeks
|
7.2%
11/153 • 52 weeks
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Renal and urinary disorders
End stage renal disease
|
2.0%
3/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Renal and urinary disorders
Renal failure
|
1.3%
2/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Renal and urinary disorders
Renal impairment
|
4.0%
6/151 • 52 weeks
|
3.9%
6/153 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Vascular disorders
Vascular rupture
|
0.66%
1/151 • 52 weeks
|
0.00%
0/153 • 52 weeks
|
Other adverse events
| Measure |
MT-6548
n=151 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
n=153 participants at risk
Darbepoetin alfa: Subcutaneous. The dose was adjusted to 15-180 ug/week, 2 weeks or 4 weeks according to the pre-specified dose adjustment algorithm.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
9.3%
14/151 • 52 weeks
|
7.2%
11/153 • 52 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
11.9%
18/151 • 52 weeks
|
5.2%
8/153 • 52 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
10/151 • 52 weeks
|
2.0%
3/153 • 52 weeks
|
|
General disorders
Oedema peripheral
|
7.3%
11/151 • 52 weeks
|
3.3%
5/153 • 52 weeks
|
|
General disorders
Pyrexia
|
5.3%
8/151 • 52 weeks
|
0.65%
1/153 • 52 weeks
|
|
Infections and infestations
Cystitis
|
4.0%
6/151 • 52 weeks
|
5.9%
9/153 • 52 weeks
|
|
Infections and infestations
Nasopharyngitis
|
24.5%
37/151 • 52 weeks
|
28.1%
43/153 • 52 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
7.3%
11/151 • 52 weeks
|
4.6%
7/153 • 52 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.3%
5/151 • 52 weeks
|
5.2%
8/153 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.3%
5/151 • 52 weeks
|
5.2%
8/153 • 52 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.6%
7/151 • 52 weeks
|
5.2%
8/153 • 52 weeks
|
|
Vascular disorders
Hypertension
|
1.3%
2/151 • 52 weeks
|
7.2%
11/153 • 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