UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023966 |
|---|---|
| Receipt number | 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 13:42:34 |
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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
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
nomuramkt@chugai-pharm.co.jp
Sponsor or person
Institute
CHUGAI Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.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 |
