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Completed

NCT Number: NCT01244763

Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia

The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.

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Key information

Conditions

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 2

Primary location

Caguas, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 to 75 years
  • Chronic kidney disease, not receiving dialysis
  • Body weight 45 to 140 kg

Exclusion criteria

  • Any clinically significant infection or evidence of an underlying infection
  • Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
  • History of chronic liver disease
  • New York Heart Association Class III or IV congestive heart failure
  • Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
  • History of malignancy
  • Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
  • History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
  • History of hemosiderosis, hemochromatosis or polycystic kidney disease
  • Active hemolysis or diagnosis of hemolytic syndrome
  • Uncontrolled or symptomatic secondary hyperparathyroidism
  • Seizure disorder or receiving anti-epilepsy medication
  • Known bone marrow fibrosis
  • Any prior or scheduled organ transplant
  • Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor
  • History of alcohol or drug abuse

Treatment and study plan

Roxadustat

Drug

Oral capsule

Other names: FG-4592

Primary outcomes

  1. Number (%) of Participants With an Hb Response by Week 17

    Time frame: Up to Week 17

    An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.

Secondary outcomes

  1. Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25

    Time frame: Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

    An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.

  2. Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25

    Time frame: Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

    Baseline is defined as the mean of the last 3 available values predose.

  3. Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28

    Time frame: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

    Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive.

  4. Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28

    Time frame: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

  5. Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25

    Time frame: Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

    Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks.

  6. Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28

    Time frame: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

  7. Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL

    Time frame: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)

    Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.

  8. Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline

    Time frame: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)

    Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.

  9. Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline

    Time frame: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)

  10. Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week

    Time frame: Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment)

  11. Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories

    Time frame: Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment])

  12. Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25

    Time frame: Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only)

    The mean percentage of the scheduled weekly Hb values that were <10.5, >13, and >14 g/dL during Weeks 13-17 and 18-25 is presented.

  13. Number (%) of Participants Requiring Rescue Therapy

    Time frame: Baseline up to Week 28 (end of study)

    Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron

  14. Number (%) of Participants Requiring Therapeutic Phlebotomy

    Time frame: Baseline up to Week 28 (end of study)

  15. Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy

    Time frame: Baseline up to Week 28 (end of study)

  16. Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24

    Time frame: Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only)

    Dose changes include dose reductions, dose increases, and dose holds.

  17. Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)

    Time frame: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)

  18. Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)

    Time frame: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)

  19. Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24

    Time frame: Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)

    Baseline was defined as the mean of the last 3 available values predose.

Sponsors and collaborators

Lead sponsor

Kyntra Bio

Industry

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

A Phase 2, Randomized, Open-Label, Dose Titration, Efficacy and Safety Study of FG-4592 (Roxadustat) in Non-Dialysis Chronic Kidney Disease Patients With Anemia

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2010
Registry last updated
Feb 10, 2022

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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