Phase 3
N=304
Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Anemia; Non-dialysis Dependent Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT03329196 ↗Enrolled (actual)
304
Serious AEs
29.9%
Results posted
Apr 2021
Primary outcome: Primary: Mean Hb Level of Week 20 and Week 24 — 11.66; 11.93 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MT-6548 (Drug); Darbepoetin alfa (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Hb Level of Week 20 and Week 24 |
11.66; 11.93 | — |
| SECONDARY Mean Hb Level of Week 48 and Week 52 |
11.54; 11.63 | — |
| SECONDARY Hb Level at Each Assessment Time Point |
10.44; 10.52; 10.64; 10.75; 10.71; 10.90 | — |
| SECONDARY Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period |
31.1; 32.7; 36.4; 37.9; 46.3; 53.3 | — |
| SECONDARY Time to Reach the Target Hb Range in Correction Group Only |
43.0; 29.0 | — |
| SECONDARY Rate of Increase in Hb Level in Correction Group Only |
0.14; 0.21; 0.13; 0.21 | — |
Summary
For Non-dialysis subjects with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548.
For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance effect of MT-6548
Eligibility Criteria
Inclusion Criteria
- Diagnosis of CKD
- eGFR 2.5 x upper limit of normal during the screening period
- Uncontrolled hypertension (diastolic blood pressure >110 mm Hg or systolic blood pressure >180 mm Hg) during the screening period and Day 1
- Ophthalmic examinations during the screening period correspond to either of the following criteria;
- No available fundal findings
- Findings indicating the presence of active fundal disease
- Severe heart failure (New York Heart Association Class IV)
- Cerebrovascular disorder or acute coronary syndrome (hospitalization due to unstable angina or myocardial infarction), requiring hospitalization due to urgent percutaneous intervention for coronary or heart failure within 12 weeks prior to the screening period
- Current or history of malignancy. History of malignancy with no recurrence for the recent 5 years is not an exclusion criterion
- New onset or recurrent event of deep vein thrombosis or pulmonary embolism within 12 weeks prior to the screening period
- Current or history of hemosiderosis or hemochromatosis
- History of prior organ transplantation or scheduled organ transplant, or prior transplantation of hematopoietic stem cell or bone marrow
- Males and females of childbearing potential who are unwilling to use an acceptable method of contraception during the designated period (Males: during the study and 90 days after the last dose, females: during study and 30 days after the last dose)
- Females who are pregnant or breast feeding, or are predicted to be pregnant
Data sourced from ClinicalTrials.gov (NCT03329196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.