Comprehensive Cohort of Anemia in Chronic Kidney Disease

JRCT ID: jRCT1040220112

Registered date:26/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Renal anemia
• Date of first enrollment: 27/03/2023
• Target sample size: 234
• Countries of recruitment: US,Japan,Argentina,Japan,Australia,Japan,Belgium,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan,Russia,Japan,Spain,Japan,South Korea,Japan,Poland,Japan,Turkey,Japan,Canada,Japan,UK,Japan
• Study type: Observational
• Intervention(s): There is no study intervention in this study. However, participant response to SoC therapies including ESAs will be documented.

Outcome(s)

Primary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 18age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Matsuoka Takeshi