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

Anemia of Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971164
• Other study ID #: AZ951-U-12-004
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2013
• Last updated: July 11, 2014
• Start date: May 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia of Chronic Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• JTZ-951
Subjects will receive JTZ-951 or Placebo
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		15 days	Yes
Primary	Vital signs and 12 lead ECGs		15 days	Yes
Primary	Cmax (maximum concentration)		15 days	No
Primary	tmax (time to reach maximum concentration)		15 days	No
Primary	t1/2 (elimination half-life)		15 days	No
Primary	AUC (area under the concentration-time curve)		15 days	No
Primary	AR (accumulation ratio)		15 days	No
Primary	RBC (red blood cell) count		15 days	No
Primary	Hgb (hemoglobin)		15 days	No
Primary	TSAT (transferrin saturation)		15 days	No
Primary	serum ferritin		15 days	No