Phase 3 N=42 Treatment

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

Anemia; Peritoneal Dialysis Dependent Chronic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT03402386 ↗

Enrolled (actual)

Serious AEs

28.6%

Results posted

Jul 2021

Primary outcome: Primary: Mean Hb Level of Week 20 and Week 24 — 11.35 g/dL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MT-6548 (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Tanabe Pharma Corporation
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Hb Level of Week 20 and Week 24	11.35	—
PRIMARY Hb Level at Each Assessment Time Point	10.90; 10.96; 10.74; 10.61; 10.87; 10.89	—
PRIMARY Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period	57.1; 60.0; 41.5; 35.9; 47.4; 44.7	—
PRIMARY Time to Reach the Target Hb Range in Correction Group Only	—	—
PRIMARY Rate of Increase in Hb Level in Correction Group Only	—	—

Summary

To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease

Eligibility Criteria

Inclusion Criteria

Diagnosis of CKD
Receiving peritoneal dialysis for more than 4 weeks prior to the screening period. However, receiving hemodialysis is excluded
Not expected to start hemodialysis during the study
Correction group: Not being treated with ESAs for the recent 8 weeks prior to the screening period
Conversion group: Being treated with ESAs for the recent 8 weeks prior to the screening period
Mean of the two screening Hb levels closest in time to the baseline visit. Correction group: ≥8.0 g/dL and 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 (e.g. 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03402386). 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.