Last updated 10 months ago

Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)

120 patients around the world

Available in Spain, Argentina, United States

GlaxoSmithKline

120Patients around the world

This study is for people with

Anemia

Renal disease

Chronic kidney disease

Requirements for the patient

To 17 Years

All Gender

Medical requirements

: 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.

: Kidney transplant recipient with a functioning allograft.
Scheduled for elective kidney transplantation within 3 months.
Transferrin saturation (TSAT) < 20 percent (%), or Ferritin <25 nanogram (ng)/milliliter (mL).
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.

StudyASCEND-P

SponsorGlaxoSmithKline

Conditions

Chronic kidney disease

Requirements

To 17 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05682326