Renal anemia
Conditions
Interventions
There is no study intervention in this study. However, participant response to SoC therapies including ESAs will be documented.
Sponsors
Fujii Katsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Participant must be 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 receiving treatment for anemia with an erythropoiesis stimulating agent (ESA) or have a Hgb <= 12.0 g/dL in ESA non-users. - Written informed consent or assent as appropriate.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - 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. - Other causes of anemia. - Active or previous malignancy within the last 2 years. - Acute or chronic infection requiring antimicrobial therapy. - Cirrhosis or current unstable liver or biliary disease. - Participation in a clinical study with a study intervention under evaluation to treatment anemia of CKD or anticipated to confound the interpretation of the Hgb.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the impact of SoC anemia management on Hgb concentrations. 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. | — |
Countries
Argentina, Australia, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Turkey, UK, US
Contacts
Public ContactKatsuya Fujii
Syneos Health Japan K.K.
Outcome results
None listed