Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
0–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant must be 3 months to less than (\<)18 years of age.
Anemia associated with CKD stage 3, 4, 5 (not on dialysis) or who have dialysis-dependent CKD, defined as Hgb 7.0 to 11.0 g/dL (if not using erythropoiesis stimulating agents \[ESAs\]) or Hgb 9.5 to 12.0 g/dL if using ESAs.
Written informed consent or assent as appropriate.
You may not be if
Kidney transplant recipient with a functioning allograft.
Scheduled for elective kidney transplantation within 3 months.
History of bone marrow aplasia or pure red cell aplasia.
Active hemolysis.
Other causes of anemia.
Active gastrointestinal bleeding within the last 4 weeks.
Active or previous malignancy within the last 2 years.
Acute or chronic infection requiring antimicrobial therapy.
History of significant thrombotic or thromboembolic events within the last 8 weeks.
Heart failure (HF) New York Heart Association (NYHA) Class IV
Uncontrolled hypertension.
Alanine aminotransferase (ALT) \>2× upper limit of normal (ULN), bilirubin \>1.5× ULN (unless bilirubin is fractionated and direct bilirubin \<35%), and cirrhosis or current unstable liver or biliary disease.
Clareo Health | Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)