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Completed

NCT Number: NCT01978587

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

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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Key information

Conditions

Anemia in Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Minneapolis, Minnesota, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JTZ-951

Drug

Primary outcomes

  1. Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis

    Time frame: Days 1 to 4 and 8 to 11

  2. tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis

    Time frame: Days 1 to 4 and 8 to 11

  3. AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis

    Time frame: Days 1 to 4 and 8 to 11

  4. t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis

    Time frame: Days 1 to 4 and 8 to 11

Secondary outcomes

  1. Number of subjects with adverse events

    Time frame: 14 days

  2. Vital signs and ECG (electrocardiogram)

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 7, 2013
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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