Trial · NCT03329196

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

NCT03329196, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2021-04-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan. Trials, record NCT03329196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03329196

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Trial

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

Title: Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
NCT number: NCT03329196
Status: Completed
Phases: Phase 3
Enrollment: 304 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Anemia; Non-dialysis Dependent Chronic Kidney Disease
Interventions: MT-6548, Darbepoetin alfa
First posted: 2017-11-01
Last updated: 2026-04-06
Results first posted: 2021-04-12

Source ClinicalTrials.gov

Registered outcomes6

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
Secondary	Mean Hb Level of Week 48 and Week 52	Up to Week 52
Secondary	Hb Level at Each Assessment Time Point	Up to Week 52
Secondary	Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period	Up to Week 52
Secondary	Time to Reach the Target Hb Range in Correction Group Only	Up to Week 52
Secondary	Rate of Increase in Hb Level in Correction Group Only	Up to Week 6

Source ClinicalTrials.gov

Outcomes6

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		g/dL	LEAST_SQUARES_MEAN
SECONDARY	Mean Hb Level of Week 48 and Week 52	Up to Week 52		g/dL	LEAST_SQUARES_MEAN
SECONDARY	Hb Level at Each Assessment Time Point	Up to Week 52	This analysis was performed only in subjects who have Hb data at each visit.	g/dL	MEAN
SECONDARY	Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period	Up to Week 52	This analysis was performed only in subjects who have Hb data at each visit.	percentage of subjects	NUMBER
SECONDARY	Time to Reach the Target Hb Range in Correction Group Only	Up to Week 52	This analysis was performed in correction group except for subjects with Hb is 11.0 g/dL or more at baseline.	days	MEDIAN
SECONDARY	Rate of Increase in Hb Level in Correction Group Only	Up to Week 6	This analysis was performed in subjects of correction group who have Hb up to week 4 or week 6.	g/dL/week	MEAN

Source ClinicalTrials.gov

Results by group80

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		11.66	95% Confidence Interval 11.49 to 11.84	g/dL
Mean Hb Level of Week 20 and Week 24	Darbepoetin Alfa		11.93	95% Confidence Interval 11.76 to 12.10	g/dL
Mean Hb Level of Week 48 and Week 52	MT-6548		11.54	95% Confidence Interval 11.38 to 11.69	g/dL
Mean Hb Level of Week 48 and Week 52	Darbepoetin Alfa		11.63	95% Confidence Interval 11.48 to 11.77	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Baseline	10.44	95% Confidence Interval 10.29 to 10.59	g/dL
Hb Level at Each Assessment Time Point	Darbepoetin Alfa	Baseline	10.52	95% Confidence Interval 10.38 to 10.66	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 2	10.64	95% Confidence Interval 10.48 to 10.80	g/dL
Hb Level at Each Assessment Time Point	Darbepoetin Alfa	Week 2	10.75	95% Confidence Interval 10.62 to 10.89	g/dL
Hb Level at Each Assessment Time Point	MT-6548	Week 4	10.71	95% Confidence Interval 10.54 to 10.89	g/dL
Hb Level at Each Assessment Time Point	Darbepoetin Alfa	Week 4	10.90	95% Confidence Interval 10.76 to 11.05	g/dL

1 to 10 of 80Source ClinicalTrials.gov

See all 80 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	MT-6548	151
Overall Study	STARTED	Darbepoetin Alfa	153
Overall Study	COMPLETED	MT-6548	111
Overall Study	COMPLETED	Darbepoetin Alfa	123
Overall Study	NOT COMPLETED	MT-6548	40
Overall Study	NOT COMPLETED	Darbepoetin Alfa	30

Source ClinicalTrials.gov

Adverse events164

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	Constipation	Gastrointestinal disorders	MT-6548	14	151
other	Constipation	Gastrointestinal disorders	Darbepoetin Alfa	11	153
other	Diarrhoea	Gastrointestinal disorders	MT-6548	18	151
other	Diarrhoea	Gastrointestinal disorders	Darbepoetin Alfa	8	153
other	Vomiting	Gastrointestinal disorders	MT-6548	10	151
other	Vomiting	Gastrointestinal disorders	Darbepoetin Alfa	3	153
other	Oedema peripheral	General disorders	MT-6548	11	151
other	Oedema peripheral	General disorders	Darbepoetin Alfa	5	153
other	Pyrexia	General disorders	MT-6548	8	151
other	Pyrexia	General disorders	Darbepoetin Alfa	1	153

1 to 10 of 164Source ClinicalTrials.gov

See all 164 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MT-6548	0	151
Total, all-cause mortality	Darbepoetin Alfa	1	153
Total, other adverse events	MT-6548	85	151
Total, other adverse events	Darbepoetin Alfa	80	153
Total, serious adverse events	MT-6548	42	151
Total, serious adverse events	Darbepoetin Alfa	49	153

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33883252	RESULT	PubMed
36005278	DERIVED	PubMed
38530490	DERIVED	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 comparisons2

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

Comparison	Source
MT-6548 vs Darbepoetin Alfa: deaths from any cause	Trial comparisons
MT-6548 vs Darbepoetin Alfa: serious adverse events	Trial comparisons

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/NCT03329196

GET https://conductscience.org/api/trials/v1/NCT03329196/results?page=2

API reference For AI assistants