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

Browse trials for

• Kidney Diseases 3,840
• Renal Insufficiency, Chronic 3,144
• Anemia 1,733

Keywords

• Kidney
• Chronic Kidney Disease
• CKD
• Renal
• Anemia
• Oral anemia treatment
• Hemoglobin levels
• Erythropoietin
• Blood count
• Predialysis
• Pre-dialysis
• Hb
• Non-dialysis

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 145 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Lead sponsor

FibroGen is the lead sponsor of 39 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.

Study arms

• Experimental
  Cohort A: Roxadustat Tiered, Weight Based Dosing TIW

  Participants will receive roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kilograms (kg)\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants will receive 60, 100, and 140 milligrams \[mg\] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.

  Drug: Roxadustat

• Experimental
  Cohort B: Roxadustat Tiered, Weight Based Dosing TIW then BIW

  Participants will receive roxadustat capsules orally for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants will receive 60, 100, and 140 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response.

  Drug: Roxadustat

• Experimental
  Cohort C: Roxadustat at 50 mg TIW

  Participants will receive roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.

  Drug: Roxadustat

• Experimental
  Cohort D: Roxadustat at 100 mg TIW

  Participants will receive roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.

  Drug: Roxadustat

• Experimental
  Cohort E: Roxadustat Tiered, Weight Based Dosing BIW then QW

  Participants will receive roxadustat capsules for 24 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight \[45 to 60 kg\], medium-weight \[\>60 to 90 kg\], and heavy-weight \[\>90 to 140 kg\] participants will receive 70, 100, and 150 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from BIW to 1 time a week (QW) at the time of the initial Hb response.

  Drug: Roxadustat

• Experimental
  Cohort F: Roxadustat at 70 mg BIW then QW

  Participants will receive roxadustat capsules at 70 mg for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after \>8 weeks of stable Hb, dose frequency will be reduced from BIW to QW.

  Drug: Roxadustat

Interventions

• DrugRoxadustat

  Oral capsule

  Also known as: FG-4592

Primary outcomes

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

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

   Time frame: Up to Week 17

Secondary outcomes

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

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

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

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

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

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

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

   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.

   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)

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

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

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

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

   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.

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

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

   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.

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

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

    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.

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

13. Number (%) of Participants Requiring Rescue Therapy

    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

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

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

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

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

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

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

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

Baseline characteristics

Publications

• Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2. PubMed 36005278 ↗