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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007693
Receipt No. R000009073
Scientific Title Effect of darbepoetin alfa on quality of life in anemia of chronic kidney disease elderly patients with type 2 diabetes mellitus
Date of disclosure of the study information 2012/04/09
Last modified on 2014/12/16

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Basic information
Public title Effect of darbepoetin alfa on quality of life in anemia of chronic kidney disease elderly patients with type 2 diabetes mellitus
Acronym Effect of darbepoetin alfa for on diabetic elderly patients with renal anemia
Scientific Title Effect of darbepoetin alfa on quality of life in anemia of chronic kidney disease elderly patients with type 2 diabetes mellitus
Scientific Title:Acronym Effect of darbepoetin alfa for on diabetic elderly patients with renal anemia
Region
Japan

Condition
Condition Renal anemia with type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Nephrology Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The prospective analysis of QOL, ADL, and cognitive function in elderly anemia patients with type 2 diabetic mellitus patients receiving darbepoetin alfa who maintained Hb in the target range (11-13g/dL, CVD patients 12g/dL).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Amount of changes QOL(SF-36) from the baseline to 3 months later after darbepoetin alfa treatment.
Key secondary outcomes 1)Changes of QOL(SF-36) from the beseline to 3 and 6 months later
2)Changes of ADL(Barthel Index) from the beseline to 3 and 6 months later
3)Changes of MMSE and GDS15 from the beseline to 3 and 6 months
4)Changes of NTpro-BNP from the beseline to 3 and 6 months later
5)Changes of L-FABP and Ucr from the beseline to 3 and 6 months later
6)Changes of MDL-LDL from the beseline to 3 and 6 months later
7)Changes of HOMA-IR and Ucr from the beseline to 3 and 6 months later
8)Proportion of subjects on maintained with a target Hb 11-13 g/dL during 6 months

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 Darbepoetin alfa is administered to renal anemia patients with chronic kidney disease not on dialysis and it maintains it to Hb value 12g/dL around
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with type 2 diabetes on glycemic control stability during 3 months
2) Patients with chronic kidney disease not on dialysis
3) Patients with renal anaemia on level of Hb is less than 10g/dL
4) Age >=65years
5) A consent form for participating in this study is submitted
Key exclusion criteria 1) Patients with cognitive impairment and on the anti cognitive impairment drug
2) Patients with impossible control of hypertension
3) Patients with impossible glycemic control
4) Patients with congestive heart failure
5) Patients with major surgery within 16 weeks
6) Patients with red blood cell (RBC) transfusions within 16 weeks
7) Patients receiving anabolic steroid hormone, testosterone enanthate, mepitiostane within 16 weeks
8) Patients with anemia caused by conditions other than renal anemia such as GI bleeding and blood desease
9) Patients with history of stroke, MI or other sever vascular complication which required a hospitalization
10) Patients with serious allergies or serious drug sensitivities
11) Patients with serious liver dysfunction (ALT or AST greater than 2 times the upper limit of hpspital standard)
12) Patients with scheduled to receive a renal replacement therapy
13) Patients having hypersensitivity to rHuEPO
14) Other patients determined to be inappropriate by physician
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koutaro Yokote
Organization Graduate School of Medicine, Chiba University
Division name Clinical Cell Biology and Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
TEL 043-226-2092
Email kyokote@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Kobayashi
Organization Graduate School of Medicine, Chiba University
Division name Clinical Cell Biology and Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, 260-8670, Chiba-city
TEL 043-226-2092
Homepage URL
Email koba-chi@faculty.chiba-u.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Graduate School of Medicine, Chiba University
Organization
Division
Category of Funding Organization Other
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
2012 Year 04 Month 09 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
2012 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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 04 Month 08 Day
Last modified on
2014 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009073

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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