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

Phase 1

Completed

• Conditions: Anemia of Chronic Kidney Disease
• Interventions: Drug: JTZ-951; Drug: Placebo

• Registration Number: NCT01971164
• Lead Sponsor: Akros Pharma Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-10-29
• Primary Completion: 2014-05
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 4 JTZ-951 or Placebo	Placebo	Tablets, 1 dose per day for 15 days
Dose 1 JTZ-951 or Placebo	Placebo	Tablets, 1 dose per day for 15 days
Dose 3 JTZ-951 or Placebo	Placebo	Tablets, 1 dose per day for 15 days
Dose 2 JTZ-951 or Placebo	Placebo	Tablets, 1 dose per day for 15 days
Dose 3 JTZ-951 or Placebo	JTZ-951	Tablets, 1 dose per day for 15 days
Dose 4 JTZ-951 or Placebo	JTZ-951	Tablets, 1 dose per day for 15 days
Dose 2 JTZ-951 or Placebo	JTZ-951	Tablets, 1 dose per day for 15 days
Dose 1 JTZ-951 or Placebo	JTZ-951	Tablets, 1 dose per day for 15 days

Primary Outcome Measures

Name	Time	Method
RBC (red blood cell) count	15 days
Vital signs and 12 lead ECGs	15 days
Hgb (hemoglobin)	15 days
TSAT (transferrin saturation)	15 days
Cmax (maximum concentration)	15 days
tmax (time to reach maximum concentration)	15 days
t1/2 (elimination half-life)	15 days
AUC (area under the concentration-time curve)	15 days
Number of subjects with adverse events	15 days
AR (accumulation ratio)	15 days
serum ferritin	15 days