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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017775 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Maintenance dialysis patients who are indicated for hemodiafiltration. | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | ASAHI KASEI MEDICAL CO., LTD. |
Institute | |
Department |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020568 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |