Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associa… (NCT03402386) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety Study to Evaluate MT-6548 in Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Japan42 participantsStarted 2018-01-03
Plain-language summary
To evaluate the efficacy and safety of MT-6548 in peritoneal dialysis subjects with anemia associated with chronic kidney disease
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \< 11.0 g/dL Conversion group: ≥9.0 g/dL and ≤12.5 g/dL
* Fluctuation between the two Hb levels closest in time to the baseline visit during the screening period less than 1.5 g/dL
* Serum ferritin ≥ 100 ng/mL, or TSAT ≥20% during the screening period
* Folate and vitamin B12 ≥ lower limit of normal during the screening period
Exclusion Criteria:
* Anemia due to a main cause other than CKD: sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia
* Active bleeding or recent blood loss within 8 weeks prior to the screening period
* RBC transfusion within 8 weeks prior to the screening period
* Received testosterone enanthate or mepitiostane within 8 weeks prior to the screening period
* Peritonitis within 4 weeks prior to the screening period
* AST, ALT, or total bilirubin \>2.5 x upper limit of normal during the screening period
* Uncontrolled hypertension (diasto…
What they're measuring
1
Mean Hb Level of Week 20 and Week 24
Timeframe: Up to Week 24
2
Hb Level at Each Assessment Time Point
Timeframe: Up to Week 24
3
Percentage of Subjects With Hb Level at Each Assessment Time Point Within the Target Range During the Treatment Period
Timeframe: Up to Week 24
4
Time to Reach the Target Hb Range in Correction Group Only
Timeframe: Up to Week 24
5
Rate of Increase in Hb Level in Correction Group Only