Post-marketing surveillance study on long-term use of MIRCERA in CKD patients.

Post-marketing surveillance study on long-term use of MIRCERA in CKD patients. - Post-marketing surveillance study on long-term use of MIRCERA in CKD patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023966

Enrollment

3250

Registered

2016-09-30

Start date

2011-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal anemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who have no previous treatment with Mircera for renal anemia

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
adverse reactions and infectious diseases	—

Secondary

Measure	Time frame
- Relationship of adverse events and change of Hb concentration - Change of Hb concentration in correction phase using MIRCERA in PD patients untreated with rHuEPO previously - Relationship between adverse events and change of Hb concentration after change of dose and/or frequency of MIRCERA administration - Dose when switching to MIRCERA from rHuEPO, and the change of Hb concentration. If the switching case to MIRCERA from darbepoetin alpha is present, research dosage and change of Hb concentration. - Dosage and change of Hb concentration at the change of administration route - Relationship between the maintenance Hb concentration level and the incidence of adverse events (especially, cardiovascular disorders) in the patients with cardiovascular diseases - If capable of being ascertained, check the expression of anti-MIRCERA antibody and anti-erythropoietin antibodies in patients who are determined to be pure red cell aplasia including the doubtful case	—

Measure

Time frame

- Relationship of adverse events and change of Hb concentration - Change of Hb concentration in correction phase using MIRCERA in PD patients untreated with rHuEPO previously - Relationship between adverse events and change of Hb concentration after change of dose and/or frequency of MIRCERA administration - Dose when switching to MIRCERA from rHuEPO, and the change of Hb concentration. If the switching case to MIRCERA from darbepoetin alpha is present, research dosage and change of Hb concentration. - Dosage and change of Hb concentration at the change of administration route - Relationship between the maintenance Hb concentration level and the incidence of adverse events (especially, cardiovascular disorders) in the patients with cardiovascular diseases - If capable of being ascertained, check the expression of anti-MIRCERA antibody and anti-erythropoietin antibodies in patients who are determined to be pure red cell aplasia including the doubtful case

—

Countries

Japan

Contacts

Public ContactMakoto Nomura

Chugai Pharmaceutical Co.Ltd Pharmacovigilance Dept

nomuramkt@chugai-pharm.co.jp03-3273-0905

Outcome results