Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease

Completed · Phase 1

Conditions studied: Anemia in Chronic Kidney Disease

In brief

The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis

Key facts

Study ID

NCT01978587

Run by

Akros Pharma Inc.

People needed

6

Starts

2013-10-01

Expected to finish

2014-01-01

Last updated by the study team

2014-03-18

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

You may not qualify if…

• Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission
• Uncontrolled hypertension at the Screening Visit or Day -1

Where it is running

• Study site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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