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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008091
Receipt No. R000009526
Scientific Title A study on treatment switch to epoetin beta pegol in patients who do not respond well to erythropoietin preparation
Date of disclosure of the study information 2012/06/03
Last modified on 2014/10/23

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Basic information
Public title A study on treatment switch to epoetin beta pegol in patients who do not respond well to erythropoietin preparation
Acronym A study on treatment switch to epoetin beta pegol in patients who do not respond well to ESA
Scientific Title A study on treatment switch to epoetin beta pegol in patients who do not respond well to erythropoietin preparation
Scientific Title:Acronym A study on treatment switch to epoetin beta pegol in patients who do not respond well to ESA
Region
Japan

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

Objectives
Narrative objectives1 A study is conducted in maintenance hemodialysis patients receiving ESA (rHuEPO) who are not responding well to rHuEPO to evaluate the efficacy of epoetin beta pegol in improving anemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of subjects who maintain target Hb level after switching from EPO to epoetin beta pegol
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switch from the EPO of pre-medical treatment to the epoetin beta pegol
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who are on hemodialysis for a prescribed period (at least 6 months) and receiving rHuEPO preparation for renal anemia for at least 3 months
Patients receiving rHuEPO at a weekly dose of 9000 IU and higher with Hb level below 10g/dL
Key exclusion criteria Patients with iron deficiency
Patients who have uncontrollable hypertension
Patients with heart failure (NYHA functional class 3or 4)
Women who are pregnant, breastfeeding, or possibly pregnant.
Patients who have known serious allergy or serious drug allergy (shock, anaphylactoid symptoms)
Patients who have malignant tumor (including hematologic malignancy), severe infection, systemic hematologic disease (e.g. myelodysplastic syndrome, hemoglobinopathy), hemolytic anemia, or apparent hemorrhagic lesion such as gastrointestinal bleeding
Patients who have received CERA before enrollment
Patients whose AST or ALT level was100 IU/L or higher in the latest examination before enrollment
Patients who received red blood cell transfusion within 16 weeks prior to enrollment
Patients who are scheduled for surgery that may cause massive bleeding during the study period
Patients who are judged ineligible by the investigator/sub-investigator
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shouichi Fujimoto
Organization University of Miyazaki
Division name Faculty of medicine
Zip code
Address 5200, kihara, Kiyotake, Miyazaki
TEL 0985-85-1510
Email fujimos@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name TATSUNORI TOIDA
Organization University of Miyazaki
Division name Faculty of medicine
Zip code
Address 5200, kihara, Kiyotake, Miyazaki
TEL 0985-85-1510
Homepage URL
Email t.toida@med.miyazaki-u.ac.jp

Sponsor
Institute Faculty of medicine, University of Miyazaki
Institute
Department

Funding Source
Organization Faculty of medicine, University of Miyazaki
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 藤元早鈴病院(宮崎県)

Other administrative information
Date of disclosure of the study information
2012 Year 06 Month 03 Day

Related information
URL releasing protocol
Publication of results 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
2012 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 06 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

Management information
Registered date
2012 Year 06 Month 03 Day
Last modified on
2014 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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