UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000011764 |
| Receipt No. | R000013756 |
| Scientific Title | Clinical effects of polysulfone membrane, NV-13U |
| Date of disclosure of the study information | 2013/09/17 |
| Last modified on | 2019/10/01 (Ver. 2) |
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| Basic information | ||
| Public title | Clinical effects of polysulfone membrane, NV-13U | |
| Acronym | Clinical effects of polysulfone membrane, NV-13U | |
| Scientific Title | Clinical effects of polysulfone membrane, NV-13U | |
| Scientific Title:Acronym | Clinical effects of polysulfone membrane, NV-13U | |
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| Condition | ||
| Condition | end-stage renal failure | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | High biocompatibility controlling that a platelet and protein attach to the film surface is important for the hemodialysis film. Biocompatibility is high in the polysulfone film, and the range of a material targeted for the removal in blood is high in the removal performance widely. However, it is a problem that the polysulfone film has many thrombopenia, adhesion of the white clot in the blood circuit. Therefore I raised a hydrophilicity, and biocompatible high polysulfone film "NV" indicating the high antithrombotic nature was released. We weigh clinical responses such as solute removal ability, the antithrombotic biocompatibility against NV with a conventional polysulfone film (APS) for hemodialysis patients. Valuable data are in this way provided in giving the safe hemodialysis treatment for the elderly patient. |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | Confirmatory |
| Trial characteristics_2 | Pragmatic |
| Developmental phase | Not applicable |
| Assessment | |
| Primary outcomes | We use conventional polysulfone film (APS - 13SA) and new polysulfone film (NV- 13 U) in 4-week crossover for a hemodialysis patients twice. And we measure solute removal ability (clearance, quantity of removal, removal rate), antithrombotic (activated solidification time, solidification ability) and compare them. |
| Key secondary outcomes | We measure a very small amount of albumin in the biocompatible (leukocyte image) dialysis waste fluid of the polysulfone film (APS - 13SA) and new polysulfone film (NV- 13 U) and compare the safety for the elderly patient. |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Cross-over |
| Randomization | Non-randomized |
| Randomization unit | |
| Blinding | Open -no one is blinded |
| Control | Active |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 2 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | four weeks of APS-13SA use, amd for two weeks of the washout period, and then four weeks of NV-13U use | |
| Interventions/Control_2 | four weeks of NV-13U use, and for two weeks of the washout period, and then four weeks of APS-13SA use | |
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| Interventions/Control_6 | ||
| Interventions/Control_7 | ||
| Interventions/Control_8 | ||
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| Interventions/Control_10 | ||
| Eligibility | ||||
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| Gender | Male and Female | |||
| Key inclusion criteria | end-stage renal failure patients with stable outpatient maintenance hemodialysis 60 years or older | |||
| Key exclusion criteria | hemodialysis patients without any cancer or acute Inflammation | |||
| Target sample size | 12 | |||
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| Organization | National Defense Medical College Hospital | ||||||
| Division name | Department of Blood Purification | ||||||
| Zip code | 359-8513 | ||||||
| Address | 3-2 Namiki, Tokorozawa Saitma, Japan | ||||||
| TEL | 04-2995-1511 | ||||||
| futebol@ndmc.ac.jp | |||||||
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| Organization | National Defense Medical College Hospital | ||||||
| Division name | Department of Blood Purification | ||||||
| Zip code | 359-8513 | ||||||
| Address | 3-2 Namiki, Tokorozawa Saitma, Japan | ||||||
| TEL | 04-2995-1511 | ||||||
| Homepage URL | |||||||
| halfmoon@ndmc.ac.jp | |||||||
| Sponsor | |
| Institute | National Defense Medical College |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Foundation for Promotion of Defense Medicine |
| Organization | |
| Division | |
| Category of Funding Organization | Non profit foundation |
| Nationality of Funding Organization | Japan |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | National Defense Medical College |
| Address | 3-2 Namiki, Tokorozawa Saitma, Japan |
| Tel | 04-2995-1511 |
| ins010@ndmc.ac.jp | |
| 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 | 防衛医科大学校病院（埼玉県） National Defense Medical College Hospital (Saitama) |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Published |
| Result | |
| URL related to results and publications | |
| Number of participants that the trial has enrolled | |
| Results | 57th Congress of the Japanese Society for Dialysis therapy In NV, quantity of of alfa1-MG and Alb removal, the Alb leakage significantly showed a high price in comparison with APS, too. In addition, We did not recognize significant difference for a platelet activity marker, a system for solidification lines, a blood count result. Thus, attention may be necessary for clinical adaptation of NV for the elderly person. |
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| Recruitment status | Completed | ||||||
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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=R000013756 |
