UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008090 |
|---|---|
| Receipt number | R000009525 |
| Scientific Title | A study on the procedure for treatment switch to epoetin beta pegol in the treatment of renal anemia in maintenance hemodialysis patients |
| Date of disclosure of the study information | 2012/06/03 |
| Last modified on | 2014/10/23 12:21:54 |
* 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
A study on the procedure for treatment switch to epoetin beta pegol in the treatment of renal anemia in maintenance hemodialysis patients
Acronym
A study on the procedure for treatment switch to epoetin beta pegol
Scientific Title
A study on the procedure for treatment switch to epoetin beta pegol in the treatment of renal anemia in maintenance hemodialysis patients
Scientific Title:Acronym
A study on the procedure for treatment switch to epoetin beta pegol
Region
| Japan |
Condition
Condition
Renal Anemia Patients on Hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study is conducted in maintenance hemodialysis patients receiving erythropoiesis stimulating agent (ESA), for whom the prior medication ESA is switched to epoetin beta pegol (CERA) with a regimen of biweekly (Q2W) followed by monthly (Q4W), to evaluate effects on Hb level, iron metabolism, and inflammation, etc. for the purpose of seeking a safer and more efficient way of switching.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Proportion of subjects who maintain target Hb level after switching from Q2W to Q4W
Key secondary outcomes
epoetin beta pegol dose, iron-related parameters
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switch from the EPO of pre-medical treatment to the epoetin beta pegol by medication once for every two weeks, and switch into medication once for every four weeks after two months.
Interventions/Control_2
Switch from the EPO of pre-medical treatment to the epoetin beta pegol by medication once for every four weeks
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
Key exclusion criteria
Patients who have uncontrollable hypertension
Patients with heart failure (NYHA functional class 3 or 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
30
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
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
t.toida@fc.miyazaki-u.ac.jp
Sponsor or person
Institute
Faculty of medicine, University of Miyazaki
Institute
Department
Personal name
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
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
| 2014 | Year | 03 | Month | 31 | Day |
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009525
