UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017775 |
|---|---|
| Receipt number | R000020568 |
| Scientific Title | Evaluation of the safety on hemodiafilter "AMPA-01" in renal failure patients. |
| Date of disclosure of the study information | 2015/06/03 |
| Last modified on | 2015/10/28 09:39:15 |
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Basic information
Public title
Evaluation of the safety on hemodiafilter "AMPA-01" in renal failure patients.
Acronym
Evaluation of the safety on AMPA-01.
Scientific Title
Evaluation of the safety on hemodiafilter "AMPA-01" in renal failure patients.
Scientific Title:Acronym
Evaluation of the safety on AMPA-01.
Region
| Japan |
Condition
Condition
Maintenance dialysis patients who are indicated for hemodiafiltration.
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of hemodiafiltration using "AMPA-01" in maintenance dialysis patients who are indicated for hemodiafiltration.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
1) The frequency of acute failure such as adverse events which is suspected to be caused by "AMPA-01".
2) Blood compatibility (Fluctuations in the number of white blood cells and platelets during hemodiafiltration.)
Key secondary outcomes
1) clearance
2) reduction rate
3) removal amount
4) protein leakage
5) transmembrane pressure
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
Hemodiafiltration using AMPA-01
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
1) Maintenance dialysis patients corresponding to
- three times per week
- more than three and a half hours in each dialysis session
- hemodialysis or hemodiafiltration for more than six months
- last one month received hemodiafiltration.
2) Qb 250 mL/min is possible when the effectiveness evaluation.
3) Outpatients.
4) Ability to give written informed consent.
5) Aged 20 to <80 years at the time of informed consent.
Key exclusion criteria
1) Need to blood purification other than AMPA-01.
2) With a medical history of anaphylaxis symptoms caused by polysulfone or polyvinylpyrrolidone (PVP).
3) Pregnant women or lactating mothers
4) With severe organ dysfunction other than kidney.
5) Patients who had participated in other clinical trial within the previous 6 months.
6) Judged ineligible by the attending physician.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HASHIMOTO Shinji |
Organization
ASAHI KASEI MEDICAL CO., LTD.
Division name
Clinical Development Department
Zip code
Address
1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo
TEL
03-3296-3787
hashimoto.sg@om.asahi-kasei.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | OHSHIMA Koji |
Organization
ASAHI KASEI MEDICAL CO., LTD.
Division name
Clinical Development Department
Zip code
Address
1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo
TEL
03-3296-3787
Homepage URL
oshima.kb@om.asahi-kasei.co.jp
Sponsor or person
Institute
ASAHI KASEI MEDICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
ASAHI KASEI MEDICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
平成27年4月13日
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 03 | 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
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 10 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 02 | Day |
Last modified on
| 2015 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020568
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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