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

Sponsor

Akros Pharma Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01971164

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

5.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia of Chronic Kidney Disease	Drug: JTZ-951 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 JTZ-951 or Placebo Tablets, 1 dose per day for 15 days	Drug: JTZ-951 Subjects will receive JTZ-951 or Placebo Drug: Placebo
Experimental: Dose 2 JTZ-951 or Placebo Tablets, 1 dose per day for 15 days	Drug: JTZ-951 Subjects will receive JTZ-951 or Placebo Drug: Placebo
Experimental: Dose 3 JTZ-951 or Placebo Tablets, 1 dose per day for 15 days	Drug: JTZ-951 Subjects will receive JTZ-951 or Placebo Drug: Placebo
Experimental: Dose 4 JTZ-951 or Placebo Tablets, 1 dose per day for 15 days	Drug: JTZ-951 Subjects will receive JTZ-951 or Placebo Drug: Placebo

Outcome Measures

Primary Outcome Measures

Number of subjects with adverse events [15 days]
Vital signs and 12 lead ECGs [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]
AR (accumulation ratio) [15 days]
RBC (red blood cell) count [15 days]
Hgb (hemoglobin) [15 days]
TSAT (transferrin saturation) [15 days]
serum ferritin [15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country
1	Lakewood	Colorado	United States
2	Miami	Florida	United States
3	Orlando	Florida	United States
4	Minneapolis	Minnesota	United States
5	Saint Paul	Minnesota	United States