Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease

Anemia in Chronic Kidney Disease Clinical Trial

Official title:

A Phase 1, Open-label, Sequential Crossover Study to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978587
• Other study ID #: AZ951-U-13-005
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2013
• Last updated: March 15, 2014
• Start date: October 2013
• Est. completion date: January 2014

Study information

• Verified date: March 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 evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• 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

Exclusion Criteria:

• Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission

• Uncontrolled hypertension at the Screening Visit or Day -1

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• JTZ-951

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	Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis		Days 1 to 4 and 8 to 11	No
Primary	tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis		Days 1 to 4 and 8 to 11	No
Primary	AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis		Days 1 to 4 and 8 to 11	No
Primary	t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis		Days 1 to 4 and 8 to 11	No
Secondary	Number of subjects with adverse events		14 days	Yes
Secondary	Vital signs and ECG (electrocardiogram)		14 days	Yes