Back to resultsSafety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
Primary Purpose
Anemia of Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JTZ-951
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anemia of Chronic Kidney Disease focused on measuring anemia, chronic kidney disease, hemodialysis
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose 1 JTZ-951 or Placebo
Dose 2 JTZ-951 or Placebo
Dose 3 JTZ-951 or Placebo
Dose 4 JTZ-951 or Placebo
Arm Description
Tablets, 1 dose per day for 15 days
Tablets, 1 dose per day for 15 days
Tablets, 1 dose per day for 15 days
Tablets, 1 dose per day for 15 days
Outcomes
Primary Outcome Measures
Number of subjects with adverse events
Vital signs and 12 lead ECGs
Cmax (maximum concentration)
tmax (time to reach maximum concentration)
t1/2 (elimination half-life)
AUC (area under the concentration-time curve)
AR (accumulation ratio)
RBC (red blood cell) count
Hgb (hemoglobin)
TSAT (transferrin saturation)
serum ferritin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01971164
Brief Title
Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Chronic Kidney Disease
Keywords
anemia, chronic kidney disease, hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose 1 JTZ-951 or Placebo
Arm Type
Experimental
Arm Description
Tablets, 1 dose per day for 15 days
Arm Title
Dose 2 JTZ-951 or Placebo
Arm Type
Experimental
Arm Description
Tablets, 1 dose per day for 15 days
Arm Title
Dose 3 JTZ-951 or Placebo
Arm Type
Experimental
Arm Description
Tablets, 1 dose per day for 15 days
Arm Title
Dose 4 JTZ-951 or Placebo
Arm Type
Experimental
Arm Description
Tablets, 1 dose per day for 15 days
Intervention Type
Drug
Intervention Name(s)
JTZ-951
Intervention Description
Subjects will receive JTZ-951 or Placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of subjects with adverse events
Time Frame
15 days
Title
Vital signs and 12 lead ECGs
Time Frame
15 days
Title
Cmax (maximum concentration)
Time Frame
15 days
Title
tmax (time to reach maximum concentration)
Time Frame
15 days
Title
t1/2 (elimination half-life)
Time Frame
15 days
Title
AUC (area under the concentration-time curve)
Time Frame
15 days
Title
AR (accumulation ratio)
Time Frame
15 days
Title
RBC (red blood cell) count
Time Frame
15 days
Title
Hgb (hemoglobin)
Time Frame
15 days
Title
TSAT (transferrin saturation)
Time Frame
15 days
Title
serum ferritin
Time Frame
15 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
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
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
Lakewood
State/Province
Colorado
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Saint Paul
State/Province
Minnesota
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36005278
Citation
Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Results Reference
derived
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Safety, Tolerability, PK & PD Study of JTZ-951 in Anemic Subjects With End-stage Renal Disease
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