Trial Outcomes & Findings for Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan (NCT NCT03461146)

NCT ID: NCT03461146

Last Updated: 2023-12-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 24 participants
• Primary outcome timeframe: Up to Week 24
• Results posted on: 2023-12-29

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	24
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	3

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	2
Overall Study Physician Decision	1

Baseline Characteristics

Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

Baseline characteristics by cohort

Measure	MT-6548 n=24 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	11 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race/Ethnicity, Customized Asian (Japanese)	24 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 24

Population: This analysis was performed in subjects who measured Hb at least one visit after baseline.

Outcome measures

Measure	MT-6548 n=23 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	10.75 g/dL Interval 10.35 to 11.14

PRIMARY outcome

Timeframe: Up to Week 24

Population: This analysis was performed only in subjects who have Hb data at each visit.

Outcome measures

Measure	MT-6548 n=24 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	9.15 g/dL Interval 8.73 to 9.57
Hb Level at Each Assessment Time Point Week 2	9.25 g/dL Interval 8.83 to 9.68
Hb Level at Each Assessment Time Point Week 4	9.53 g/dL Interval 9.03 to 10.04
Hb Level at Each Assessment Time Point Week 6	9.90 g/dL Interval 9.37 to 10.43
Hb Level at Each Assessment Time Point Week 8	10.33 g/dL Interval 9.8 to 10.85
Hb Level at Each Assessment Time Point Week 10	10.56 g/dL Interval 10.08 to 11.04
Hb Level at Each Assessment Time Point Week 12	10.68 g/dL Interval 10.18 to 11.19
Hb Level at Each Assessment Time Point Week 16	11.17 g/dL Interval 10.66 to 11.68
Hb Level at Each Assessment Time Point Week 20	11.08 g/dL Interval 10.73 to 11.43
Hb Level at Each Assessment Time Point Week 24	11.03 g/dL Interval 10.6 to 11.45
Hb Level at Each Assessment Time Point Week 24 (LOCF)	10.56 g/dL Interval 9.95 to 11.17

PRIMARY outcome

Timeframe: Up to Week 24

Population: This analysis was performed only in subjects who have Hb data at each visit.

Outcome measures

Measure	MT-6548 n=24 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 Week 10	63.2 percentage of subjects
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period Week 12	68.4 percentage of subjects
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period Week 16	63.2 percentage of subjects
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period Week 20	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 24	73.7 percentage of subjects
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period Baseline	16.7 percentage of subjects
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period Week 2	21.7 percentage of subjects
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period Week 4	36.4 percentage of subjects
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period Week 6	47.6 percentage of subjects
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period Week 8	55.0 percentage of subjects

PRIMARY outcome

Timeframe: Up to Week 24

Population: This analysis was performed except for subjects with Hb of 10.0 g/dL or more at baseline.

Outcome measures

Measure	MT-6548 n=20 Participants MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Time to Reach the Target Hb Range	67.2 days Interval 45.8 to 88.6

PRIMARY outcome

Timeframe: Up to Week 6

Population: This analysis was performed in subjects who measured Hb up to week 4 or week 6.

Outcome measures

Measure	MT-6548 n=22 Participants MT-6548: Oral tablet. The dose was adjusted to 150-600 mg/day according to the pre-specified dose adjustment algorithm.
Rate of Increase in Hb Level Calculated based on Hb at baseline and Week 4	0.05 g/dL/week Interval -0.05 to 0.16
Rate of Increase in Hb Level Calculated based on Hb up to Week6	0.09 g/dL/week Interval 0.01 to 0.17

Adverse Events

MT-6548

Serious events: 7 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	MT-6548 n=24 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 Duodenal ulcer haemorrhage	4.2% 1/24 • 24 weeks
Infections and infestations Pneumonia	4.2% 1/24 • 24 weeks
Injury, poisoning and procedural complications Arteriovenous fistula occlusion	4.2% 1/24 • 24 weeks
Injury, poisoning and procedural complications Clavicle fracture	4.2% 1/24 • 24 weeks
Injury, poisoning and procedural complications Pelvic fracture	4.2% 1/24 • 24 weeks
Injury, poisoning and procedural complications Shunt stenosis	4.2% 1/24 • 24 weeks
Injury, poisoning and procedural complications Vascular access malfunction	4.2% 1/24 • 24 weeks
Vascular disorders Aneurysm	4.2% 1/24 • 24 weeks
Vascular disorders Peripheral arterial occlusive disease	4.2% 1/24 • 24 weeks

Other adverse events

Measure	MT-6548 n=24 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 Diarrhoea	16.7% 4/24 • 24 weeks
Gastrointestinal disorders Vomiting	8.3% 2/24 • 24 weeks
Infections and infestations Nasopharyngitis	20.8% 5/24 • 24 weeks
Injury, poisoning and procedural complications Shunt stenosis	20.8% 5/24 • 24 weeks
Injury, poisoning and procedural complications Skin abrasion	12.5% 3/24 • 24 weeks

Additional Information

Clinical Trials, Information Desk

Mitsubishi Tanabe Pharma Corporation

Phone: +81-3-5960-9608 Japanese only

Email: cti-inq-ml@ml.mt-pharma.co.jp

Results disclosure agreements

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

Restriction type: OTHER