Trial · NCT03402386

Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

NCT03402386, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2021-07-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan. Trials, record NCT03402386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03402386

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
NCT number: NCT03402386
Status: Completed
Phases: Phase 3
Enrollment: 42 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease
Interventions: MT-6548
First posted: 2018-01-18
Last updated: 2026-04-06
Results first posted: 2021-07-06

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Mean Hb Level of Week 20 and Week 24	Up to Week 24
Primary	Hb Level at Each Assessment Time Point	Up to Week 24
Primary	Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period	Up to Week 24
Primary	Time to Reach the Target Hb Range in Correction Group Only	Up to Week 24
Primary	Rate of Increase in Hb Level in Correction Group Only	Up to Week 6

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Hb Level of Week 20 and Week 24	Up to Week 24	This analysis was performed in subjects who measured Hb at least one visit after baseline.	g/dL	LEAST_SQUARES_MEAN
PRIMARY	Hb Level at Each Assessment Time Point	Up to Week 24	This analysis was performed only in subjects who have Hb data at each visit.	g/dL	MEAN
PRIMARY	Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period	Up to Week 24	This analysis was performed only in subjects who have Hb data at each visit.	percentage of subjects	NUMBER
PRIMARY	Time to Reach the Target Hb Range in Correction Group Only	Up to Week 24	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.
PRIMARY	Rate of Increase in Hb Level in Correction Group Only	Up to Week 6	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.

Source ClinicalTrials.gov

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Hb Level of Week 20 and Week 24	MT-6548		11.35	95% Confidence Interval 10.99 to 11.70	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Baseline	10.90	95% Confidence Interval 10.56 to 11.25	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 2	10.96	95% Confidence Interval 10.54 to 11.38	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 4	10.74	95% Confidence Interval 10.31 to 11.17	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 6	10.61	95% Confidence Interval 10.09 to 11.13	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 8	10.87	95% Confidence Interval 10.41 to 11.33	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 10	10.89	95% Confidence Interval 10.45 to 11.32	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 12	11.10	95% Confidence Interval 10.67 to 11.53	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 16	11.58	95% Confidence Interval 11.12 to 12.04	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 20	11.68	95% Confidence Interval 11.24 to 12.13	g/dL

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow5

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	MT-6548	42
Overall Study	Correction Group	MT-6548	2
Overall Study	Conversion Group	MT-6548	40
Overall Study	COMPLETED	MT-6548	36
Overall Study	NOT COMPLETED	MT-6548	6

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain upper	Gastrointestinal disorders	MT-6548	3	42
other	Diarrhoea	Gastrointestinal disorders	MT-6548	8	42
other	Nausea	Gastrointestinal disorders	MT-6548	3	42
other	Vomiting	Gastrointestinal disorders	MT-6548	4	42
other	Catheter site infection	Infections and infestations	MT-6548	9	42
other	Nasopharyngitis	Infections and infestations	MT-6548	6	42
other	Decreased appetite	Metabolism and nutrition disorders	MT-6548	3	42
serious	Anaemia	Blood and lymphatic system disorders	MT-6548	1	42
serious	Cardiac failure chronic	Cardiac disorders	MT-6548	1	42
serious	Myocardial ischaemia	Cardiac disorders	MT-6548	1	42

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MT-6548	1	42
Total, other adverse events	MT-6548	21	42
Total, serious adverse events	MT-6548	12	42

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33283981	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03402386

GET https://conductscience.org/api/trials/v1/NCT03402386/results?page=2

API reference For AI assistants