NCT01971164

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Akros Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Anemia of Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	JTZ-951	Subjects will receive JTZ-951 or Placebo
DRUG	Placebo

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2013-10-29
• Last updated: 2014-07-14

Locations

5 sites across 1 country: United States