Back to resultsEffect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
Primary Purpose
Anemia in Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JTZ-951
Sponsored by
About this trial
This is an interventional treatment trial for Anemia in Chronic Kidney Disease focused on measuring End-stage Renal Disease, Hemodialysis, Pharmacokinetics
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dose 1 JTZ-951
Dose 2 JTZ-951
Arm Description
Tablets, 1 dose on Day 1 before hemodialysis
Tablets, 1 dose on Day 8 after hemodialysis
Outcomes
Primary Outcome Measures
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis
AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis
t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis
Secondary Outcome Measures
Number of subjects with adverse events
Vital signs and ECG (electrocardiogram)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01978587
Brief Title
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akros Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia in Chronic Kidney Disease
Keywords
End-stage Renal Disease, Hemodialysis, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1 JTZ-951
Arm Type
Experimental
Arm Description
Tablets, 1 dose on Day 1 before hemodialysis
Arm Title
Dose 2 JTZ-951
Arm Type
Experimental
Arm Description
Tablets, 1 dose on Day 8 after hemodialysis
Intervention Type
Drug
Intervention Name(s)
JTZ-951
Primary Outcome Measure Information:
Title
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis
Time Frame
Days 1 to 4 and 8 to 11
Title
tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis
Time Frame
Days 1 to 4 and 8 to 11
Title
AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis
Time Frame
Days 1 to 4 and 8 to 11
Title
t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis
Time Frame
Days 1 to 4 and 8 to 11
Secondary Outcome Measure Information:
Title
Number of subjects with adverse events
Time Frame
14 days
Title
Vital signs and ECG (electrocardiogram)
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hideyuki Yamamoto
Organizational Affiliation
Akros Pharma Inc.
Official's Role
Study Chair
Facility Information:
City
Minneapolis
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease
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