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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Anemia in Chronic Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose 1 JTZ-951

Tablets, 1 dose on Day 1 before hemodialysis

Group Type EXPERIMENTAL

JTZ-951

Intervention Type DRUG

Dose 2 JTZ-951

Tablets, 1 dose on Day 8 after hemodialysis

Group Type EXPERIMENTAL

JTZ-951

Intervention Type DRUG

Interventions

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JTZ-951

Intervention Type DRUG

Eligibility Criteria

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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