Title:
DRUG FOR PREVENTING DIALYSIS SHIFT OR RENAL DEATH
Document Type and Number:
WIPO Patent Application WO/2021/132302
Kind Code:
A1
Abstract:
Provided is a drug for preventing dialysis shift or renal death, which, when administered in the form of a sustained-release preparation containing, as an active ingredient, a compound represented by general formula (I) to a specific group of patients, can prevent dialysis shift or renal death. Provided is a drug for preventing dialysis shift or renal death, which comprises an oral sustained-release preparation containing, as an active ingredient, a compound represented by general formula (I), the drug being used in such a manner that the compound represented by general formula (I) is administered at a dose of 220 to 260 μg per day to a primary glomerular disease or nephrosclerosis patient having a serum creatinine level of 2.0 mg/dl or more and less than 3.0 mg/dl and/or nutritional disturbance. [In the formula, R represents a hydrogen atom or a pharmacologically acceptable cation.]
Inventors:
KURUMATANI HAJIME (JP)
OKADA KIYONOBU (JP)
YAMADA NAOHIRO (JP)
KIRIYAMA NAO (JP)
KANO HIROYUKI (JP)
YAMADA SHUNSUKE (JP)
OKADA KIYONOBU (JP)
YAMADA NAOHIRO (JP)
KIRIYAMA NAO (JP)
KANO HIROYUKI (JP)
YAMADA SHUNSUKE (JP)
Application Number:
PCT/JP2020/048091
Publication Date:
July 01, 2021
Filing Date:
December 23, 2020
Export Citation:
Assignee:
TORAY INDUSTRIES (JP)
ASTELLAS PHARMA INC (JP)
ASTELLAS PHARMA INC (JP)
International Classes:
A61K9/06; A61K31/5585; A61K9/20; A61K45/00; A61K47/38; A61P13/12; A61P43/00
Domestic Patent References:
| WO2016031949A1 | 2016-03-03 | |||
| WO2004098611A1 | 2004-11-18 | |||
| WO2000067748A1 | 2000-11-16 | |||
| WO2000067748A1 | 2000-11-16 | |||
| WO2004098611A1 | 2004-11-18 | |||
| WO1998041210A1 | 1998-09-24 | |||
| WO2004103350A1 | 2004-12-02 |
Foreign References:
| JP2005232003A | 2005-09-02 |
Other References:
AKIO KOYAMA; TOSHIRO FUJITA; FUMITAKE GEJYO; HIDEKI ORIGASA; MASANAO ISONO; HAJIMU KURUMATANI; KIYONOBU OKADA; HIROYUKI KANOH; TAK: "Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo- controlled, phase II dose finding trial", BMC NEPHROLOGY, vol. 16, no. 165, 16 October 2015 (2015-10-16), XP021229138, DOI: 10.1186/s12882-015-0130-5
NAKAMOTO HIDETOMO, FUJITA TOSHIRO, ORIGASA HIDEKI, ISONO MASANAO, KURUMATANI HAJIMU, OKADA KIYONOBU, KANOH HIROYUKI, KIRIYAMA TAKA: "A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design", BMC NEPHROLOGY, vol. 15, no. 153, 19 September 2014 (2014-09-19), pages 1 - 8, XP021196855, DOI: 10.1186/1471-2369-15-153
NAKAMOTO HIDETOMO, YU XUE‐QING, KIM SUHNGGWON, ORIGASA HIDEKI, ZHENG HONGGUANG, CHEN JIANGHUA, JOO KWON WOOK, SRITIPPAYAWAN SUCHAI: "Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results", THERAPEUTIC APHERESIS AND DIALYSIS, vol. 24, no. 1, February 2020 (2020-02-01), pages 42 - 55, XP055838051, DOI: 10.1111/1744-9987.12840
TAKENAKA ET AL., J VET INTERN MED, vol. 32, 2018, pages 236
FUJITA ET AL., PROSTAGLANDINS, LEUKOTRIENES AND ESSENTIAL FATTY ACIDS, vol. 65, no. 4, 2001, pages 223 - 227
FUJITA ET AL., VASCULAR BIOLOGY & MEDICINE, vol. 7, 2006, pages 281
KOYAMA ET AL., BMC NEPHROLOGY, vol. 16, 2015, pages 165
NAKAMOTO ET AL., BMC NEPHROLOGY, vol. 15, 2014, pages 153
NAKAMOTO ET AL., THER APHER DIAL., 23 May 2019 (2019-05-23)
LEVEY ET AL., AM J KIDNEY DIS., vol. 64, 2014, pages 821 - 835
HAMADA ET AL., SHIKOKU ACTA MEDICA, vol. 69, no. 5,6, 2013, pages 211 - 214
CLINICAL GUIDELINES FOR SARCOPENIA, 2017, pages 2
"Study on Health Business for Late-Stage Elderly", 2015 MINISTRY OF HEALTH, LABOR AND WELFARE RESEARCH GRANT, 2015
NOFUJI ET AL., COMMUNITY MEDICINE, vol. 32, no. 4, 2018, pages 312 - 320
KAJIKAWA ET AL., ARZNEIMITTELFORSCHUNG, vol. 39, 1989, pages 495 - 9
SHIMAMURA ET AL., J CLIN PHARMACOL., vol. 57, 2017, pages 524 - 535
LEVEY ET AL., ANN INTERN MED, vol. 150, 2009, pages 604 - 612
JAPANESE SOCIETY OF NEPHROLOGY, EVIDENCE-BASED PRACTICE GUIDELINE FOR THE TREATMENT OF CKD, 2009, pages 3
NAKAMOTO HIDETOMO, FUJITA TOSHIRO, ORIGASA HIDEKI, ISONO MASANAO, KURUMATANI HAJIMU, OKADA KIYONOBU, KANOH HIROYUKI, KIRIYAMA TAKA: "A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design", BMC NEPHROLOGY, vol. 15, no. 153, 19 September 2014 (2014-09-19), pages 1 - 8, XP021196855, DOI: 10.1186/1471-2369-15-153
NAKAMOTO HIDETOMO, YU XUE‐QING, KIM SUHNGGWON, ORIGASA HIDEKI, ZHENG HONGGUANG, CHEN JIANGHUA, JOO KWON WOOK, SRITIPPAYAWAN SUCHAI: "Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results", THERAPEUTIC APHERESIS AND DIALYSIS, vol. 24, no. 1, February 2020 (2020-02-01), pages 42 - 55, XP055838051, DOI: 10.1111/1744-9987.12840
TAKENAKA ET AL., J VET INTERN MED, vol. 32, 2018, pages 236
FUJITA ET AL., PROSTAGLANDINS, LEUKOTRIENES AND ESSENTIAL FATTY ACIDS, vol. 65, no. 4, 2001, pages 223 - 227
FUJITA ET AL., VASCULAR BIOLOGY & MEDICINE, vol. 7, 2006, pages 281
KOYAMA ET AL., BMC NEPHROLOGY, vol. 16, 2015, pages 165
NAKAMOTO ET AL., BMC NEPHROLOGY, vol. 15, 2014, pages 153
NAKAMOTO ET AL., THER APHER DIAL., 23 May 2019 (2019-05-23)
LEVEY ET AL., AM J KIDNEY DIS., vol. 64, 2014, pages 821 - 835
HAMADA ET AL., SHIKOKU ACTA MEDICA, vol. 69, no. 5,6, 2013, pages 211 - 214
CLINICAL GUIDELINES FOR SARCOPENIA, 2017, pages 2
"Study on Health Business for Late-Stage Elderly", 2015 MINISTRY OF HEALTH, LABOR AND WELFARE RESEARCH GRANT, 2015
NOFUJI ET AL., COMMUNITY MEDICINE, vol. 32, no. 4, 2018, pages 312 - 320
KAJIKAWA ET AL., ARZNEIMITTELFORSCHUNG, vol. 39, 1989, pages 495 - 9
SHIMAMURA ET AL., J CLIN PHARMACOL., vol. 57, 2017, pages 524 - 535
LEVEY ET AL., ANN INTERN MED, vol. 150, 2009, pages 604 - 612
JAPANESE SOCIETY OF NEPHROLOGY, EVIDENCE-BASED PRACTICE GUIDELINE FOR THE TREATMENT OF CKD, 2009, pages 3
Attorney, Agent or Firm:
HIRAKI & ASSOCIATES (JP)
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