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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01978587

Enrollment

Registered

2013-11-07

Start date

2013-10-31

Completion date

2014-01-31

Last updated

2014-03-18

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

Conditions

Anemia in Chronic Kidney Disease

Keywords

End-stage Renal Disease, Hemodialysis, Pharmacokinetics

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

Interventions

DRUGJTZ-951

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

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

Exclusion criteria

* Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission * Uncontrolled hypertension at the Screening Visit or Day -1

Design outcomes

Primary

Measure	Time frame
Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis	Days 1 to 4 and 8 to 11
tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis	Days 1 to 4 and 8 to 11
AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis	Days 1 to 4 and 8 to 11
t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis	Days 1 to 4 and 8 to 11

Secondary

Measure	Time frame
Number of subjects with adverse events	14 days
Vital signs and ECG (electrocardiogram)	14 days

Countries

United States

Outcome results

None listed

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