Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
NCT ID: NCT01971164
Last Updated: 2014-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2013-05-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dose 1 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
JTZ-951
Subjects will receive JTZ-951 or Placebo
Placebo
Dose 2 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
JTZ-951
Subjects will receive JTZ-951 or Placebo
Placebo
Dose 3 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
JTZ-951
Subjects will receive JTZ-951 or Placebo
Placebo
Dose 4 JTZ-951 or Placebo
Tablets, 1 dose per day for 15 days
JTZ-951
Subjects will receive JTZ-951 or Placebo
Placebo
Interventions
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JTZ-951
Subjects will receive JTZ-951 or Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit
* Hemoglobin value as defined in the protocol
* Meet the erythropoiesis-stimulating agent (ESA) therapy criteria at the Screening Visit as defined in the protocol
Exclusion Criteria
* Anemia due to known causes other than chronic kidney disease
* Known history of hyporesponsiveness to ESAs
* Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to Screening visit
18 Years
75 Years
ALL
No
Sponsors
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Akros Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hideyuki Yamamoto
Role: STUDY_CHAIR
Akros Pharma Inc.
Locations
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Lakewood, Colorado, United States
Miami, Florida, United States
Orlando, Florida, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Countries
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References
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Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Other Identifiers
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AZ951-U-12-004
Identifier Type: -
Identifier Source: org_study_id
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