UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014744 |
|---|---|
| Receipt number | R000017139 |
| Scientific Title | Blood purification treatments for removal of protein-bound uremic toxins |
| Date of disclosure of the study information | 2014/08/05 |
| Last modified on | 2016/02/01 19:40:10 |
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Basic information
Public title
Blood purification treatments for removal of protein-bound uremic toxins
Acronym
Blood purification treatments for removal of protein-bound uremic toxins
Scientific Title
Blood purification treatments for removal of protein-bound uremic toxins
Scientific Title:Acronym
Blood purification treatments for removal of protein-bound uremic toxins
Region
| Japan |
Condition
Condition
Chronic kidney disease undergoing hemodialysis treatment
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate blood purification treatments with better removal of protein-bound uremic toxins
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Removal of several protein-bound uremic toxins
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of adsorption column (Lixelle S-35) with regular hemodialysis treatment for 6 times
Interventions/Control_2
Hemodialysis treatment using polymethyl methacrylate-dialyzer for 6 times
Interventions/Control_3
Hemodialysis treatment using polysulfone-dialyzer for 6 times
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with chronic kidney disease undergoing hemodialysis treatment for 5 to 10 years
Key exclusion criteria
1) Patients with pregnancy
2) Body weight less than 40 kg
3) Patients with allergic disease
4) Patients who have cardiovascular disease within one month
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichiro J. Kazama |
Organization
Niigata University Medical and Dental Hospital
Division name
Blood Purification Center
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
0252272770
jjkaz@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Science
Division name
Clinical Nephroscience
Zip code
Address
1-757 Asahimachi-dori, Chuou-ku, Niigata, 951-8510Japan
TEL
0252270436
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2014 | Year | 08 | Month | 05 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 05 | 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
| 2014 | Year | 08 | Month | 01 | Day |
Last modified on
| 2016 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017139
