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Recruitment status Terminated
Unique ID issued by UMIN UMIN000006661
Receipt No. R000007872
Scientific Title Clinical study to evaluate the efficacy and safety of darbepoetin-alfa in kidney transplant recipients with erythropoietin-resistant anemia
Date of disclosure of the study information 2011/12/01
Last modified on 2017/05/22

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Basic information
Public title Clinical study to evaluate the efficacy and safety of darbepoetin-alfa in kidney transplant recipients with erythropoietin-resistant anemia
Acronym Darbepoetin-alfa for erythropoietin-resistant post transplant anemia
Scientific Title Clinical study to evaluate the efficacy and safety of darbepoetin-alfa in kidney transplant recipients with erythropoietin-resistant anemia
Scientific Title:Acronym Darbepoetin-alfa for erythropoietin-resistant post transplant anemia
Region
Japan

Condition
Condition Post-transplantation anemia
Classification by specialty
Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of darbepoetin-alfa for erythropoietin-resistant anemia in kidney transplant recipients

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1.Mean hemoglobin level at the end of the study.
2.Percentage of patients with hemoglobin level within the target range of 11 to 13 g/dL at the end of the study
Key secondary outcomes 1.Dose of darbepoetin-alfa
2.Changes in estimated glomerular filtration rate
3.Changes in blood pressure

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Darbepoetin-alfa for 6-12 months
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 1.Kidney transplant patients
2.Patients who have continued EPO treatment for more than three months
3.Patients who have hemoglobin <11g/dL in spite of EPO treatment
Key exclusion criteria 1.Patients with active infection or malignancy
2.Patients who receive surgical management
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Siro Takahara
Organization Osaka University Graduate School of Medicine
Division name Department of Advanced Technology for Transplant
Zip code
Address 2-2 Yamada-oka, Suita, Osaka
TEL 06-6879-3746
Email kakuta@uro.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kakuta Yoichi
Organization Osaka University Graduate School of Medicine
Division name Department of Specific Organ Regulation (Urology)
Zip code
Address 2-2 Yamada-oka, Suita, Osaka
TEL 06-6879-3531
Homepage URL
Email kakuta@uro.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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 大阪大学医学部附属病院(大阪府)
蒼龍会井上病院(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Terminated
Date of protocol fixation
2011 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2017 Year 05 Month 22 Day
Date of closure to data entry
2017 Year 05 Month 22 Day
Date trial data considered complete
2017 Year 05 Month 22 Day
Date analysis concluded
2017 Year 05 Month 22 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 02 Day
Last modified on
2017 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007872

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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