Trial · NCT03461146
Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
NCT03461146, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2021-05-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan. Trials, record NCT03461146. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03461146
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 Hemodialysis Subjects Not Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan
- NCT number
- NCT03461146
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 24 participants, actual
- Lead sponsor
- Tanabe Pharma Corporation
- Conditions
- Anemia; Hemodialysis Dependent Chronic Kidney Disease
- Interventions
- MT-6548
- First posted
- 2018-03-09
- Last updated
- 2026-04-06
- Results first posted
- 2021-05-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Up to Week 24 | |
| Primary | Rate of Increase in Hb Level | 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 | Up to Week 24 | This analysis was performed except for subjects with Hb of 10.0 g/dL or more at baseline. | days | MEAN |
| PRIMARY | Rate of Increase in Hb Level | Up to Week 6 | This analysis was performed in subjects who measured Hb up to week 4 or week 6. | g/dL/week | MEAN |
Source ClinicalTrials.gov
Results by group25
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 | 10.75 | 95% Confidence Interval 10.35 to 11.14 | g/dL | |
| Hb Level at Each Assessment Time Point | MT-6548 | Baseline | 9.15 | 95% Confidence Interval 8.73 to 9.57 | g/dL |
| Hb Level at Each Assessment Time Point | MT-6548 | Week 2 | 9.25 | 95% Confidence Interval 8.83 to 9.68 | g/dL |
| Hb Level at Each Assessment Time Point | MT-6548 | Week 4 | 9.53 | 95% Confidence Interval 9.03 to 10.04 | g/dL |
| Hb Level at Each Assessment Time Point | MT-6548 | Week 6 | 9.90 | 95% Confidence Interval 9.37 to 10.43 | g/dL |
| Hb Level at Each Assessment Time Point | MT-6548 | Week 8 | 10.33 | 95% Confidence Interval 9.80 to 10.85 | g/dL |
| Hb Level at Each Assessment Time Point | MT-6548 | Week 10 | 10.56 | 95% Confidence Interval 10.08 to 11.04 | g/dL |
| Hb Level at Each Assessment Time Point | MT-6548 | Week 12 | 10.68 | 95% Confidence Interval 10.18 to 11.19 | g/dL |
| Hb Level at Each Assessment Time Point | MT-6548 | Week 16 | 11.17 | 95% Confidence Interval 10.66 to 11.68 | g/dL |
| Hb Level at Each Assessment Time Point | MT-6548 | Week 20 | 11.08 | 95% Confidence Interval 10.73 to 11.43 | g/dL |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MT-6548 | 24 | |
| Overall Study | COMPLETED | MT-6548 | 21 | |
| Overall Study | NOT COMPLETED | MT-6548 | 3 |
Source ClinicalTrials.gov
Adverse events14
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | MT-6548 | 4 | 24 | |
| other | Vomiting | Gastrointestinal disorders | MT-6548 | 2 | 24 | |
| other | Nasopharyngitis | Infections and infestations | MT-6548 | 5 | 24 | |
| other | Shunt stenosis | Injury, poisoning and procedural complications | MT-6548 | 5 | 24 | |
| other | Skin abrasion | Injury, poisoning and procedural complications | MT-6548 | 3 | 24 | |
| serious | Duodenal ulcer haemorrhage | Gastrointestinal disorders | MT-6548 | 1 | 24 | |
| serious | Pneumonia | Infections and infestations | MT-6548 | 1 | 24 | |
| serious | Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | MT-6548 | 1 | 24 | |
| serious | Clavicle fracture | Injury, poisoning and procedural complications | MT-6548 | 1 | 24 | |
| serious | Pelvic fracture | Injury, poisoning and procedural complications | MT-6548 | 1 | 24 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MT-6548 | 0 | 24 |
| Total, other adverse events | MT-6548 | 15 | 24 |
| Total, serious adverse events | MT-6548 | 7 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34115437 | 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.
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/NCT03461146
GET https://conductscience.org/api/trials/v1/NCT03461146/results?page=2