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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01971164

Enrollment

Registered

2013-10-29

Start date

2013-05-31

Completion date

2014-07-31

Last updated

2014-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Chronic Kidney Disease

Keywords

anemia, chronic kidney disease, hemodialysis

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.

Interventions

DRUGJTZ-951

Subjects will receive JTZ-951 or Placebo

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of subjects with adverse events	15 days
Vital signs and 12 lead ECGs	15 days
Cmax (maximum concentration)	15 days
tmax (time to reach maximum concentration)	15 days
t1/2 (elimination half-life)	15 days
AUC (area under the concentration-time curve)	15 days
AR (accumulation ratio)	15 days
RBC (red blood cell) count	15 days
Hgb (hemoglobin)	15 days
TSAT (transferrin saturation)	15 days
serum ferritin	15 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026