The objective of this study is to evaluate the safety and efficacy of ASP1517 in peritoneal dialysis chronic kidney disease patients with anemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Oral
Site JP00002
Aichi, Japan
Site JP00004
Aichi, Japan
Site JP00010
Aichi, Japan
Site JP00013
Aichi, Japan
Hemoglobin (Hb) Response Rate from Week 18 to Week 24
Hb response defined as average Hb within the target range in this outcome
Time frame: Up to Week 24
Hb Response rate
Hb response is defined as reaching target values for Hb and change of Hb from baseline in this outcome.
Time frame: Up to Week 24
Average Hb levels from week 18 to week 24
Time frame: Up to week 24
Change from baseline in the average Hb levels of week 18 to week 24
Time frame: Baseline and up to Week 24
Rate of rise in Hb levels (g/dL/week)
Time frame: Up to Week 4
Proportion of time points with target Hb levels
Time frame: Up to Week 24
Proportion of participants who achieve the target Hb level at each week
Time frame: Up to Week 24
Proportion of participants who achieve the lower limit of the target Hb level
Time frame: Up to Week 24
Time to achieve the lower limit of the target Hb level
Time frame: Up to Week 24
Change from baseline in Hb level at each week
Time frame: Baseline and Up to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site JP00001
Fukuoka, Japan
Site JP00005
Fukuoka, Japan
Site JP00012
Hokkaido, Japan
Site JP00014
Hokkaido, Japan
Site JP00006
Ishikawa, Japan
Site JP00008
Kanagawa, Japan
...and 5 more locations
Efficacy assessed by hematocrit
Hematocrit will be summarized by ASP1517 low dose Erythropoieses Stimulating Agent (ESA) untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
Time frame: Up to Week 24
Efficacy assessed by reticulocytes/ erythrocytes
Reticulocytes/Erythrocytes will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
Time frame: Up to Week 24
Efficacy assessed by Iron (Fe)
Fe will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
Time frame: Up to Week 24
Efficacy assessed by ferritin
Ferritin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
Time frame: Up to Week 24
Efficacy assessed by transferrin
Transferrin will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
Time frame: Up to Week 24
Efficacy assessed by total iron binding capacity
Total iron binding capacity will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
Time frame: Up to Week 24
Efficacy assessed by soluble transferrin receptor
Soluble transferrin receptor will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
Time frame: Up to Week 24
Efficacy assessed by transferrin saturation
Transferrin saturation will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
Time frame: Up to Week 24
Efficacy assessed by reticulocyte hemoglobin content
Reticulocyte hemoglobin content will be summarized by ASP1517 low dose ESA untreated group, ASP1517 high dose ESA untreated group and ASP1517 ESAs treated Group.
Time frame: Up to Week 24
Quality of life assessed by SF-36
SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey
Time frame: Up to Week 24
Quality of life assessed by EQ-5D
EQ-5D: EuroQol 5 Dimension
Time frame: Up to Week 24
Quality of life assessed by FACT-An
FACT-An: Functional Assessment of Cancer Therapy-Anemia
Time frame: Up to Week 24
Occurrence of hospitalizations
Time frame: Up to Week 24
Safety assessed by incidence of adverse events
Time frame: Up to Week 24
Number of participants with abnormal Vital signs and/or adverse events related to treatment
Time frame: Up to Week 24
Safety assessed by standard 12-lead electrocardiogram
Time frame: Up to Week 24
Number of participants with abnormal Laboratory values and/or adverse events related to treatment
Time frame: Up to Week 24
Plasma concentration of unchanged ASP1517
Time frame: Up to Week 24