Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis

Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis - MIRACLE-CKD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000008568

Enrollment

5000

Registered

2012-07-31

Start date

2012-08-01

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 associated with chronic kidney disease(CKD) not on dialysis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: CKD patients not on dialysis associated with renal anemia, and 1)MIRCERA-na&iuml;ve patients with the hemoglobin level less than 11g/dL 2)patients estimated not to introduce dialysis for at least six months after starting MIRCERA administration

Exclusion criteria

Exclusion criteria: 1)patients with anemia by other than renal anemia, such as by overt hemorrhage, by hematological disorders (leukemia, malignant lymphoma, myelodysplastic syndrome, or aplastic anemia, and others), and patients undergoing myelosuppressive treatment (chemotherapy or radiation therapy) 2)patients within one year after kidney transplantation 3)patients with eGFR of less than 6mL/min/1.73m2

Design outcomes

Primary

Measure	Time frame
Renal survival defined the periods until the earliest days occurred one of the three composite events; 1)renal replacement therapy 2)doubling of serum creatinine 3)eGFR less than 6.0mL/min/1.73m2	—

Countries

Japan

Contacts

Public ContactIZUMI KAWASHIMA

CHUGAI PHARMACEUTICAL CO., LTD. PHARMACOVIGILANCE DEPT.

kawashimaizm@chugai-pharm.co.jp03-3273-0769

Outcome results