EUCTR2021-004022-30-HUActive, not recruitingPhase 1
A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE AFTER CONVERSION FROM AN ERYTHROPOIESIS-STIMULATING AGENT
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Akebia Therapeutics, Inc.
- Enrollment
- 71
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •*Diagnosis of anemia of chronic kidney disease (CKD)
- •*Diagnosis of non-dialysis-dependent (NDD) CKD with an estimated glomerular filtration rate of greater than (>) 10 and less than (<) 60 milliliters/minute/1.73 meters^2 (mL/min/1.73 m^2) or diagnosis of dialysis dependent (DD) CKD
- •*Mean hemoglobin (Hb) between 9.0 and 12.0 grams/deciliters (g/dL) (inclusive)
- •*Transferrin Saturation = 20%
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 71
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •*Anemia due to a cause other than CKD
- •*Active bleeding or recent clinically significant blood loss
- •*History of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia
- •*Red Blood Cells transfusion within 4 weeks
- •*Serum albumin level less than 2.5 g/dL
- •*Uncontrolled hypertension
- •*Active malignancy or treatment for malignancy within the past 2 years prior to Screening
- •*Evidence of iron overload or diagnosis of hemochromatosis
- •*Known hypersensitivity to vadadustat or any excipients in vadadustat tablet
Investigators
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