UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009429 |
|---|---|
| Receipt number | R000010676 |
| Scientific Title | Clinical Trial for evaluation of the clinical effect of on line hemodiafiltration (HDF) and beta2-microglobulin adsorption column combination therapy. |
| Date of disclosure of the study information | 2012/11/29 |
| Last modified on | 2016/08/20 10:02:40 |
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Basic information
Public title
Clinical Trial for evaluation of the clinical effect of on line hemodiafiltration (HDF) and beta2-microglobulin adsorption column combination therapy.
Acronym
Clinical Trial for evaluation of the clinical effect of on line hemodiafiltration (HDF) and beta2-microglobulin adsorption column combination therapy.
Scientific Title
Clinical Trial for evaluation of the clinical effect of on line hemodiafiltration (HDF) and beta2-microglobulin adsorption column combination therapy.
Scientific Title:Acronym
Clinical Trial for evaluation of the clinical effect of on line hemodiafiltration (HDF) and beta2-microglobulin adsorption column combination therapy.
Region
| Japan |
Condition
Condition
dialysis-related amyloidosis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of on line HDF and beta2-microglobulin adsorption column therapy for long-term hemodialysis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of clinical symptoms, circulatory dynamics, and nutritional and inflammatory status.
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
| Device,equipment |
Interventions/Control_1
Change from hemodialysis (HD) to on line HDF (1st phase: for 4 months)
Combine on line HDF and beta2-microglobulin adsorption column. (2nd phase: for 4 months)
Return from on line HDF and beta2-microglobulin adsorption column combination to on line HDF only (3rd phase, same as 1st phase: for 4 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)Patients who has initiated hemodialysis before more than 10 years.
(2)Patients with dialysis-related amyloidosis or similar symptoms.
Key exclusion criteria
Nothing
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nakanishi |
Organization
Hyogo College of Medicine
Division name
Division of Kidney and Dialysis, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6521
kuragano@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Kuragano |
Organization
Hyogo College of Medicine
Division name
Division of Kidney and Dialysis, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6521
Homepage URL
kuragano@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Miyamoto Clinic
Motomachi HD Clinic
Hiwasa Clinic
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 | 11 | Month | 29 | 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
Main results already published
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | 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 | 11 | Month | 29 | Day |
Last modified on
| 2016 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010676
