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

Akros Pharma

Status and phase: Completed; Phase 1

Conditions: Anemia in Chronic Kidney Disease

Treatments: Drug: JTZ-951

Study type: Interventional

Funder types: Industry

Identifiers

NCT01978587

AZ951-U-13-005

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Dose 1 JTZ-951

Experimental group

Description:

Tablets, 1 dose on Day 1 before hemodialysis

Treatment:

Drug: JTZ-951

Dose 2 JTZ-951

Experimental group

Description:

Tablets, 1 dose on Day 8 after hemodialysis

Treatment:

Drug: JTZ-951