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Completed

NCT Number: NCT01971164

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

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.

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Key information

Conditions

Anemia of Chronic Kidney Disease Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases 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

Lakewood, Colorado, United States

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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
  • 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

Treatment and study plan

JTZ-951

Drug

Subjects will receive JTZ-951 or Placebo

Placebo

Drug

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: 15 days

  2. Vital signs and 12 lead ECGs

    Time frame: 15 days

  3. Cmax (maximum concentration)

    Time frame: 15 days

  4. tmax (time to reach maximum concentration)

    Time frame: 15 days

  5. t1/2 (elimination half-life)

    Time frame: 15 days

  6. AUC (area under the concentration-time curve)

    Time frame: 15 days

  7. AR (accumulation ratio)

    Time frame: 15 days

  8. RBC (red blood cell) count

    Time frame: 15 days

  9. Hgb (hemoglobin)

    Time frame: 15 days

  10. TSAT (transferrin saturation)

    Time frame: 15 days

  11. serum ferritin

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Akros Pharma Inc.

Industry

Registry information

Official study title

Randomized, Single-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTZ-951 Administered Once Daily for 15 Days in Anemic Subjects With End-stage Renal Disease

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2013
Registry last updated
Jul 14, 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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