Anemia Chronic Kidney Disease
Conditions
Interventions
None listed
Sponsors
GSK Research & Development Limited
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be
Exclusion criteria
Exclusion criteria: 1. Kidney transplant recipient with a functioning allograft. 2. Scheduled for elective kidney transplantation within 3 months. 3. Aplasias: History of bone marrow aplasia or pure red cell aplasia. 4. Other causes of anemia: e.g., thalassemia major, sickle cell disease or myelodysplastic syndrome. Note: Sickle cell trait is acceptable if the participant otherwise meets entry criteria. 5. Unresolved acute or active chronic infection requiring antimicrobial therapy. 6. History of malignancy within the prior 2 years or currently receiving treatment for cancer or renal lesions, for which, in the opinion of the investigator, malignancy cannot be excluded. Note: In the case of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated, the exclusion timeline is within the last 4 weeks. 7. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones and chronic hepatitis B or C) are acceptable if the participant otherwise meets entry criteria. 8. Participants who are currently participating in a clinical study with a study intervention (IMP or licensed drug), which is under evaluation to treat anemia associated with CKD or is anticipated to confound the interpretation of the Hgb status of the participant. 9. Participants with any history of hypersensitivity to daprodustat or its excipients, or to any other HIF-PHI. 10. Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study. 11. Participants who are receiving a HIF-PHI (including daprodustat), whether licensed or within a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At each study time point: • Hgb value. • Hgb change from baseline (Day 1). • Hgb above, below and within the range 10 to 12 g/dL. During the study: • For participants who initiate ESA therapy for the first time during the study, the Hgb value at the time of ESA initiation, and 4 and 8 weeks after ESA initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| ESA usage at each study time point described as: • ESA usage overall and by type • ESA dose and standardized ESA dose • ESA dose changes from baseline (Day 1) During the study: • Incidence of ESA initiation • Incidence of all AEs and Serious Adverse Events (SAEs). • In addition, although there is no study intervention, the incidence of: o Adverse Events of Special Interest (AESI) defined in this protocol. o AEs leading to discontinuation of ESA SoC therapy. • Changes from baseline in laboratory safety parameters, blood pressure (BP), heart rate (HR), height and weight at each time point. | — |
Countries
Netherlands
Outcome results
None listed