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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001634 |
Receipt No. | R000001964 |
Scientific Title | Antiproteinuric effect of recombinant human erythropoietin (rHuEPO) in predialysis chronic kidney disease (CKD) patients: multicenter observational study |
Date of disclosure of the study information | 2009/01/14 |
Last modified on | 2014/01/18 |
Basic information | ||
Public title | Antiproteinuric effect of recombinant human erythropoietin (rHuEPO) in predialysis chronic kidney disease (CKD) patients: multicenter observational study | |
Acronym | Antiproteinuric effect of rHuEPO in predialysis CKD patients | |
Scientific Title | Antiproteinuric effect of recombinant human erythropoietin (rHuEPO) in predialysis chronic kidney disease (CKD) patients: multicenter observational study | |
Scientific Title:Acronym | Antiproteinuric effect of rHuEPO in predialysis CKD patients | |
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Condition | ||
Condition | Predialysis CKD patients treated with recombinant human erythropoietin (rHuEPO) | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the antiproteinuric effect of recombinant human erythropoietin (rHuEPO) in predialysis CKD patients. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Reduction in proteinuria |
Key secondary outcomes | Correlation between reduction in proteinuria and increase in Hb. |
Base | |
Study type | Observational |
Study design | |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | Outpatients with chronic kidney disease (CKD) who had been examined urinary protein:urinary creatinine ratio for at leaset 3 months before- and after- starting rHuEPO. | |||
Key exclusion criteria | Patients with cancer, liver cirrhosis, maintenance dialysis and pregnancy were excluded. Patients who were started or changed with antihypertensives or diuretics or who required admission within 6 months before- and after- rHuEPO initiation. | |||
Target sample size | 50 |
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Name of lead principal investigator |
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Organization | Osaka University Graduate School of Medicine | ||||||
Division name | Nephrology | ||||||
Zip code | |||||||
Address | Box: B6, 2-2, Yamadaoka, Suita-city, Osaka, Japan | ||||||
TEL | 06-6879-3857 | ||||||
furumatsu@yahoo.co.jp |
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Name of contact person |
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Organization | Osaka University Graduate School of Medicine | ||||||
Division name | Nephrology | ||||||
Zip code | |||||||
Address | Box: B6, 2-2, Yamadaoka, Suita-city, Osaka, Japan | ||||||
TEL | 06-6879-3857 | ||||||
Homepage URL | |||||||
furumatsu@yahoo.co.jp |
Sponsor | |
Institute | Osaka General Medical Center
Department of Kidney Disease and Hypertension |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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Other related organizations | |
Co-sponsor | Osaka University Hospital |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | In puromycin aminonucleoside (PAN)-induced nephropathy model rats, reduction in proteinuria by rHuEPO was observed (Eto N, et al. Kidney International (2007) 72, 455–463), which are considered to be amelioration of podocyte injury (CM Logar, et al. Kidney International (2007) 72, 489–498). However, in daily clinical practice, antiproteinuric effect of EPO has never been explored. To assess the antiproteinuric effect of EPO, we conducted a multi-center observational study. |
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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=R000001964 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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