UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011872 |
|---|---|
| Receipt number | R000013870 |
| Scientific Title | Anti-Thrombotic new membrane can Improve the Tendency of Blood Pressure down during HD Study |
| Date of disclosure of the study information | 2013/09/26 |
| Last modified on | 2015/05/15 08:44:06 |
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Basic information
Public title
Anti-Thrombotic new membrane can Improve the Tendency of Blood Pressure down during HD Study
Acronym
ATHRITE BP Study
Scientific Title
Anti-Thrombotic new membrane can Improve the Tendency of Blood Pressure down during HD Study
Scientific Title:Acronym
ATHRITE BP Study
Region
| Japan |
Condition
Condition
Hypotension in hemodialysis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate whether treatment times on hypotension during hemodialysis (HD) decrease or not when the patients who hypotension is observed during HD are treated with Toraylight NV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The event number of hypotension during dialysis is observed for 6 months on two groups of NV group and conventional DL group. (NV group; conventional dialyzers are changed to NV. Conventional DL group; conventional dialyzers are used continuously.)
Key secondary outcomes
1) Hemodynamics: Blood pressure at 0 and 240 minutes after the beginning of session, Catecholamine.
2) Dialysis dose: BUN (KT/V), Beta2-MG
3) Physique, electrolyte: BMI,Na,K,Cl,chest x-ray (CTR)
4) Ca, phosphate metabolism: P, Ca, int-PTH
5) Control anemia: Hb, EPO dose, serum ferritin
6) Nutritional status: serume Alb concentration.
7) Inflammatory status: high sensitive CRP, Pentraxin 3
8) Lipid: Total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol
9)Oxidative stress: Homocysteine, Pentosidine
10) Arteriosclerosis index: PWV, ABI
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Dialyzers will be changed to the dialyzer, Toraylight NV, having good biocompatibility on patients who need to treatment for hypotension during dialysis.
Interventions/Control_2
Polysulfone(without NV) dialyzers will not be changed on patients who need to treatment for hypotension during dialysis.
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
1) Stable hemodialysis patients whose primary disease is diabetic nephropathy. (Patients have the dialysis vintage more than 1 year.)
2) The patients whose age is between 20 and 80 years at the time of enrollment in this study.
3) The patients who are using polysulfone dialyzers (PS, PES, PEPA) excluding NV series and VPS series.
4) The patients who receive treatment for hypotension induced by dialysis more than twice a month.
Key exclusion criteria
1) A patient who is treated with other renal insufficiency therapies, continuous ambulatory peritoneal dialysis and hemodiafiltration, excluding hemodialysis.
2) A patient who is enrolled to other clinical study.
3) Cancer bearing patients.
4) A patient who has anamnestic cardiovascular diseases (heart attack, stroke) in less than 3 months.
5) A patient during infectious disease treatment.
6) A patient who is consider as onset of acute inflammation.
7) A patient who is a pregnant or intends to become a pregnant within one year.
8) A patient who is judged as the inadequate subject of this study by the doctor.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minakuchi Jun |
Organization
Kawashima Hospital
Division name
Division of Nephrology, Endocrinology
Zip code
Address
1-39 Kitasako Ichiban-cho, Tokushima , Tokushima 770-0011, Japan
TEL
088-631-0110
minakuchi_j@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuchida Kenji |
Organization
Kawashima Hospital
Division name
Division of Nephrology, Endocrinology
Zip code
Address
1-39 Kitasako Ichiban-cho, Tokushima , Tokushima 770-0011, Japan
TEL
088-631-0110
Homepage URL
ktsuchida@khg.or.jp
Sponsor or person
Institute
ATHRITE BP Study Group
Institute
Department
Personal name
Funding Source
Organization
Toray Industries, Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 09 | Month | 26 | 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 | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 26 | Day |
Last modified on
| 2015 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013870
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