Clinical trial NCT01244763: Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Anemia
Keywords: Kidney
Chronic Kidney Disease
CKD
Renal
Anemia
Oral anemia treatment
Hemoglobin levels
Erythropoietin
Blood count
Predialysis
Pre-dialysis
Hb
Non-dialysis
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2010-11-19
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number (%) of Participants With an Hb Response by Week 17
timeFrame: Up to Week 17
Secondary outcomes:
measure: Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25
timeFrame: Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
measure: Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25
timeFrame: Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)
measure: 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
timeFrame: 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)
measure: Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL
timeFrame: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)
measure: Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline
timeFrame: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)
measure: Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline
timeFrame: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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])
measure: Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25
timeFrame: Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only)
measure: Number (%) of Participants Requiring Rescue Therapy
timeFrame: Baseline up to Week 28 (end of study)
measure: Number (%) of Participants Requiring Therapeutic Phlebotomy
timeFrame: Baseline up to Week 28 (end of study)
measure: Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy
timeFrame: Baseline up to Week 28 (end of study)
measure: Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24
timeFrame: Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only)
measure: 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)
timeFrame: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)
measure: Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)
timeFrame: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)
measure: Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24
timeFrame: Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Pine Bluff
country: United States
state: Arkansas
city: Azusa
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Downey
country: United States
state: California
city: Northridge
country: United States
state: California
city: Paramount
country: United States
state: California
city: Riverside
country: United States
state: California
city: Whittier
country: United States
state: California
city: Yuba City
country: United States
state: California
city: Fort Lauderdale
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Meridian
country: United States
state: Idaho
city: Wichita
country: United States
state: Kansas
city: Baton Rouge
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Bethesda
country: United States
state: Maryland
city: Detroit
country: United States
state: Michigan
city: Lincoln
country: United States
state: Nebraska
city: Mount Laurel
country: United States
state: New Jersey
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Orangeburg
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Caguas
country: Puerto Rico
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
References:
citation: 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.