Benefit-risk assessment of MIRCERA and other ESAs using the BRAT framework

Benefit-risk assessment of MIRCERA and other ESAs using the BRAT framework - Benefit-risk assessment of MIRCERA and other ESAs using the BRAT framework

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015525

Enrollment

500

Registered

2014-10-24

Start date

2014-08-22

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

Chronic renal insufficiency

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The analysis set will include patients with chronic renal insufficiency who meet these conditions and have continuously receive MIRCERA or other ESAs for a duration of at least 6 months (the difference between the date of initial dose and the date of final dose is at least 180 days) since July 2011 (after the product launch of MIRCERA) or later.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
Benefit and risk assessment includes the following parameters and will not employ a weighted approach for any parameter. Benefit: Anemia Improving Effect Hb Maintaining Effect Blood Transfusion-Free Number of Visits Suppression of Renal Insufficiency Progression (Renal Protection) ADL Improvement Risk: Vascular Access Thrombosis Hypertension Hypertensive Encephalopathy Decreased Platelet Count Aplasia Pure Red Cel Hypersensitive Reaction Cardiovascular Adverse Event (Heart Disease) Thromboembolism Including Pulmonary Embolism Gastrointestinal Hemorrhage Cerebral hemorrhage as risk associated with similar drugs	—

Measure

Time frame

Benefit and risk assessment includes the following parameters and will not employ a weighted approach for any parameter. Benefit: Anemia Improving Effect Hb Maintaining Effect Blood Transfusion-Free Number of Visits Suppression of Renal Insufficiency Progression (Renal Protection) ADL Improvement Risk: Vascular Access Thrombosis Hypertension Hypertensive Encephalopathy Decreased Platelet Count Aplasia Pure Red Cel Hypersensitive Reaction Cardiovascular Adverse Event (Heart Disease) Thromboembolism Including Pulmonary Embolism Gastrointestinal Hemorrhage Cerebral hemorrhage as risk associated with similar drugs

—

Countries

Japan

Contacts

Public ContactNatsuko Miyawaki

Chugai Pharmaceutical Co.Ltd. Drug Safety Div.

miyawakintk@chugai-pharm.co.jp03-3281-6611

Outcome results