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

Anemia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244763
• Other study ID #: FGCL-4592-041
• Status: Completed
• Phase: Phase 2
• Start date: October 29, 2010
• Est. completion date: June 13, 2012

Study information

• Verified date: January 2022
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: June 13, 2012
• Est. primary completion date: June 13, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 75 years

2. Chronic kidney disease, not receiving dialysis

3. Body weight 45 to 140 kg

Exclusion Criteria:

1. Any clinically significant infection or evidence of an underlying infection

2. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)

3. History of chronic liver disease

4. New York Heart Association Class III or IV congestive heart failure

5. Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization

6. History of malignancy

7. Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission

8. History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia

9. History of hemosiderosis, hemochromatosis or polycystic kidney disease

10. Active hemolysis or diagnosis of hemolytic syndrome

11. Uncontrolled or symptomatic secondary hyperparathyroidism

12. Seizure disorder or receiving anti-epilepsy medication

13. Known bone marrow fibrosis

14. Any prior or scheduled organ transplant

15. Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor

16. History of alcohol or drug abuse

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Roxadustat
Oral capsule

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
FibroGen	Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Week 17
Secondary	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.	Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
Secondary	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.	Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
Secondary	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.	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)
Secondary	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		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)
Secondary	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.	Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
Secondary	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		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)
Secondary	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.	Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)
Secondary	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.	Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)
Secondary	Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to =1.0 g/dL From Baseline		Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)
Secondary	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		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)
Secondary	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		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])
Secondary	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.	Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only)
Secondary	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	Baseline up to Week 28 (end of study)
Secondary	Number (%) of Participants Requiring Therapeutic Phlebotomy		Baseline up to Week 28 (end of study)
Secondary	Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy		Baseline up to Week 28 (end of study)
Secondary	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.	Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only)
Secondary	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)		Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)
Secondary	Mean Weekly Dose After Achieving First Hb Response (Hb Increase =1 g/dL From Baseline and Hb =11 g/dL)		Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)
Secondary	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.	Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)