Clinical trial NCT01971164: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia of Chronic Kidney Disease
Keywords: anemia
chronic kidney disease
hemodialysis
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-29
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: 15 days
measure: Vital signs and 12 lead ECGs
timeFrame: 15 days
measure: Cmax (maximum concentration)
timeFrame: 15 days
measure: tmax (time to reach maximum concentration)
timeFrame: 15 days
measure: t1/2 (elimination half-life)
timeFrame: 15 days
measure: AUC (area under the concentration-time curve)
timeFrame: 15 days
measure: AR (accumulation ratio)
timeFrame: 15 days
measure: RBC (red blood cell) count
timeFrame: 15 days
measure: Hgb (hemoglobin)
timeFrame: 15 days
measure: TSAT (transferrin saturation)
timeFrame: 15 days
measure: serum ferritin
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Minneapolis
country: United States
state: Minnesota
city: Saint Paul
country: United States
state: Minnesota
Study officials:
affiliation: Akros Pharma Inc.
name: Hideyuki Yamamoto
role: STUDY_CHAIR
References:
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.