UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007693 |
|---|---|
| Receipt number | 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 10:30:59 |
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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
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
koba-chi@faculty.chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009073
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