UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Post-marketing surveillance study on long-term use of MIRCERA in CKD patients.
Title of the study (Brief title)	Post-marketing surveillance study on long-term use of MIRCERA in CKD patients.
Region	Japan

Condition
Condition	Renal anemia
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Grasp of the incidence of adverse events in the long-term use of MIRCERA
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	adverse reactions and infectious diseases
Key secondary outcomes	- 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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have no previous treatment with Mircera for renal anemia
Key exclusion criteria	None
Target sample size	3250

Research contact person
Name of lead principal investigator	Joji Mochizuki
Organization	CHUGAI PHARMACEUTICAL CO., LTD.
Division name	PHARMACOVIGILANCE DEPT.
Address	2-1-1 NIHONBASHI-MUROMACHI, CHUO-KU,
TEL	03-3273-0769
Email	mochizukijuj@chugai-pharm.co.jp

Public contact
Name of contact person	Makoto Nomura
Organization	Chugai Pharmaceutical Co.Ltd
Division name	Pharmacovigilance Dept
Address	1-1 Nihonbashi-muromachi 2-chome,Chuo-ku Tokyo,Japan
TEL	03-3273-0905
Homepage URL
Email	nomuramkt@chugai-pharm.co.jp

Sponsor
Institute	CHUGAI Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization	CHUGAI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 04 Month 28 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	None

Management information
Registered date	2016 Year 09 Month 07 Day
Last modified on	2016 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027591