UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028465 |
|---|---|
| Receipt number | R000029445 |
| Scientific Title | Direct hemoperfusion of protein-bound uremic toxins |
| Date of disclosure of the study information | 2017/07/31 |
| Last modified on | 2018/06/04 20:15:48 |
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Basic information
Public title
Direct hemoperfusion of protein-bound uremic toxins
Acronym
Protein-bound uremic toxin adsorption from blood
Scientific Title
Direct hemoperfusion of protein-bound uremic toxins
Scientific Title:Acronym
Protein-bound uremic toxin adsorption from blood
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 examine adsorption of protein-bound uremic toxins with direct hemoperfusion using charcoal adsorbent in vitro
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of blood level of several protein-bound uremic toxins in vitro
Key secondary outcomes
Change of other uremic toxins and electrolytes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients undergoing maintenance hemodialysis treatment
Key exclusion criteria
Patients who treat infection.
Pregnancy.
Duration of dialysis treatment less than 1 year.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suguru Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Blood Purification Therapy
Zip code
Address
1-754 Asahimachi-dori, Chuou-ku, Niigata, 951-8520
TEL
025-227-2770
yamamots@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Blood Purification Therapy
Zip code
Address
1-754 Asahimachi-dori, Chuou-ku, Niigata, 951-8520
TEL
025-227-2770
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Division of Blood Purification Therapy, Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kureha Corporation,
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
新潟大学医歯学総合病院（新潟）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 31 | 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
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We'll collect blood from hemodialysis patients and examine an in vitro direct hemoperfusion using charcoal for protein-bound uremic toxins.
Management information
Registered date
| 2017 | Year | 07 | Month | 31 | Day |
Last modified on
| 2018 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029445
