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

Status:	Completed
Conditions:	Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:	Hematology, Nephrology / Urology
Healthy:	No
Age Range:	18 - 75
Updated:	5/5/2014
Start Date:	May 2013
End Date:	August 2014
Contact:	Hideyuki Yamamoto
Email:	yamamoto@akrospharma.com
Phone:	609-919-6111

Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTZ-951 Administered Once Daily for 15 Days in Anemic Subjects With End-stage Renal Disease

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

We found this trial at

sites

Clinical Trial Facility in Saint Paul Minnesota

Saint Paul, Minnesota 55114

from

Saint Paul, MN