Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease

Completed · Phase 1 · Has a placebo group

Conditions studied: Anemia of Chronic Kidney Disease

In brief

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of sequential ascending doses of JTZ-951 administered for 15 days in anemic subjects with end-stage renal disease (ESRD) receiving hemodialysis.

Key facts

Study ID

NCT01971164

Run by

Akros Pharma Inc.

People needed

29

Starts

2013-05-01

Expected to finish

2014-07-01

Last updated by the study team

2014-07-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
• 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

You may not qualify if…

• Transferrin saturation and ferritin levels at the Screening Visit as defined in the protocol
• 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

Where it is running

• Study site — Lakewood, Colorado, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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