Trial Outcomes & Findings for Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan (NCT NCT03402386)
NCT ID: NCT03402386
Last Updated: 2023-12-28
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
42 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.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
Correction Group
|
2
|
|
Overall Study
Conversion Group
|
40
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
6
|
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.
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Difficult to control Hb
|
2
|
Baseline Characteristics
Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Baseline characteristics by cohort
| Measure |
MT-6548
n=42 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Japanese)
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Other)
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
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=41 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
|---|---|
|
Mean Hb Level of Week 20 and Week 24
|
11.35 g/dL
Interval 10.99 to 11.7
|
PRIMARY outcome
Timeframe: Up to Week 24Population: This analysis was performed only in subjects who have Hb data at each visit.
Outcome measures
| Measure |
MT-6548
n=42 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
|---|---|
|
Hb Level at Each Assessment Time Point
Baseline
|
10.90 g/dL
Interval 10.56 to 11.25
|
|
Hb Level at Each Assessment Time Point
Week 2
|
10.96 g/dL
Interval 10.54 to 11.38
|
|
Hb Level at Each Assessment Time Point
Week 4
|
10.74 g/dL
Interval 10.31 to 11.17
|
|
Hb Level at Each Assessment Time Point
Week 6
|
10.61 g/dL
Interval 10.09 to 11.13
|
|
Hb Level at Each Assessment Time Point
Week 8
|
10.87 g/dL
Interval 10.41 to 11.33
|
|
Hb Level at Each Assessment Time Point
Week 10
|
10.89 g/dL
Interval 10.45 to 11.32
|
|
Hb Level at Each Assessment Time Point
Week 12
|
11.10 g/dL
Interval 10.67 to 11.53
|
|
Hb Level at Each Assessment Time Point
Week 16
|
11.58 g/dL
Interval 11.12 to 12.04
|
|
Hb Level at Each Assessment Time Point
Week 20
|
11.68 g/dL
Interval 11.24 to 12.13
|
|
Hb Level at Each Assessment Time Point
Week 24
|
11.39 g/dL
Interval 11.0 to 11.79
|
|
Hb Level at Each Assessment Time Point
Week 24 (LOCF)
|
11.01 g/dL
Interval 10.54 to 11.47
|
PRIMARY outcome
Timeframe: Up to Week 24Population: This analysis was performed only in subjects who have Hb data at each visit.
Outcome measures
| Measure |
MT-6548
n=42 Participants
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day 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
|
57.1 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 2
|
60.0 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 4
|
41.5 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 6
|
35.9 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 8
|
47.4 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 10
|
44.7 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 12
|
44.7 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 16
|
32.4 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 20
|
66.7 percentage of subjects
|
|
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Week 24
|
65.7 percentage of subjects
|
PRIMARY outcome
Timeframe: Up to Week 24Population: The target number of subjects by correction and conversion group was not pre-specified in the study protocol, and only 2 subjects were enrolled in the correction group as a result. The reason no data have been shown in this column is that this planned analysis wasn't performed due to such insufficient and very small amount of data from the correction group.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to Week 6Population: The target number of subjects by correction and conversion group was not pre-specified in the study protocol, and only 2 subjects were enrolled in the correction group as a result. The reason no data have been shown in this column is that this planned analysis wasn't performed due to such insufficient and very small amount of data from the correction group.
Outcome measures
Outcome data not reported
Adverse Events
MT-6548
Serious events: 12 serious events
Other events: 21 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MT-6548
n=42 participants at risk
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
1/42 • 24 weeks
|
|
Cardiac disorders
Cardiac failure chronic
|
2.4%
1/42 • 24 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
2.4%
1/42 • 24 weeks
|
|
Gastrointestinal disorders
Gastric polyps
|
2.4%
1/42 • 24 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
2.4%
1/42 • 24 weeks
|
|
Infections and infestations
Catheter site infection
|
2.4%
1/42 • 24 weeks
|
|
Infections and infestations
Peritonitis
|
7.1%
3/42 • 24 weeks
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • 24 weeks
|
|
Injury, poisoning and procedural complications
Peritoneal dialysis complication
|
2.4%
1/42 • 24 weeks
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
2.4%
1/42 • 24 weeks
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
2.4%
1/42 • 24 weeks
|
|
Nervous system disorders
Cerebral infarction
|
2.4%
1/42 • 24 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
4.8%
2/42 • 24 weeks
|
Other adverse events
| Measure |
MT-6548
n=42 participants at risk
MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
3/42 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
19.0%
8/42 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
7.1%
3/42 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
9.5%
4/42 • 24 weeks
|
|
Infections and infestations
Catheter site infection
|
21.4%
9/42 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
6/42 • 24 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
3/42 • 24 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