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

Akros Pharma

Status and phase: Completed; Phase 1

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: Placebo; Drug: JTZ-951

Study type: Interventional

Funder types: Industry

Identifiers

NCT01971164

AZ951-U-12-004

Details and patient eligibility

About

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.

Enrollment: 29 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 4 patient groups

Dose 1 JTZ-951 or Placebo

Experimental group

Description:

Tablets, 1 dose per day for 15 days

Treatment:

Drug: JTZ-951

Drug: Placebo

Dose 2 JTZ-951 or Placebo

Experimental group

Description:

Tablets, 1 dose per day for 15 days

Treatment:

Drug: JTZ-951

Drug: Placebo

Dose 3 JTZ-951 or Placebo

Experimental group

Description:

Tablets, 1 dose per day for 15 days

Treatment:

Drug: JTZ-951

Drug: Placebo

Dose 4 JTZ-951 or Placebo

Experimental group

Description:

Tablets, 1 dose per day for 15 days

Treatment:

Drug: JTZ-951

Drug: Placebo