UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023966
Receipt No. R000027591
Scientific Title Post-marketing surveillance study on long-term use of MIRCERA in CKD patients.
Date of disclosure of the study information 2016/09/30
Last modified on 2016/09/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Post-marketing surveillance study on long-term use of MIRCERA in CKD patients.
Acronym Post-marketing surveillance study on long-term use of MIRCERA in CKD patients.
Scientific Title Post-marketing surveillance study on long-term use of MIRCERA in CKD patients.
Scientific Title:Acronym 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
1st name
Middle name
Last name Joji Mochizuki
Organization CHUGAI PHARMACEUTICAL CO., LTD.
Division name PHARMACOVIGILANCE DEPT.
Zip code
Address 2-1-1 NIHONBASHI-MUROMACHI, CHUO-KU,
TEL 03-3273-0769
Email mochizukijuj@chugai-pharm.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Nomura
Organization Chugai Pharmaceutical Co.Ltd
Division name Pharmacovigilance Dept
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 04 Month 28 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.