A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF ROXADUSTAT FOR THE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS

Not Applicable

• Conditions: -D638 Anaemia in other chronic diseases classified elsewhere; Anaemia in other chronic diseases classified elsewhere; D638

• Registration Number: PER-058-15
• Lead Sponsor: Astellas Pharma Europe B.V.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-16
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

 
1.Informed Consent and privacy language must be obtained from the subject or legally authorized representative
2.Subject age is ≥ 18 years.
3.Subject has a diagnosis of chronic kidney disease, with KDOQI Stage 3, 4 or 5, not receiving dialysis.
4.The mean of the subject’s three most recent Hb values, must be ≤ 10.0 g/dL, with a difference of ≤ 1.0 g/dL between the highest and the lowest values.
5.Ferritin level ≥ 30 ng/mL at screening.
6.Transferrin saturation level ≥ 5% at screening.
7.Serum folate level ≥ lower limit of normal at screening.
8.Serum vitamin B12 level ≥ lower limit of normal at screening.
9.ALT, AST levels are ≤ 3 x upper limit of normal, and total bilirubin is ≤ 1.5 x ULN.
10.Subject’s body weight is 45.0 kg up to a maximum of 160.0 kg.
11.Female subject is either:
•Of non-child bearing potential:
•If of child bearing potential:
-agree not to try to become pregnant during the study and for 28 days after the final study drug administration.
-a negative serum pregnancy test at screening, and
-agree to use a highly effective form of birth control throughout the study period, and continued for 28 days after the last study treatment administration.
12.Male subject and their female partner who are of childbearing potential must use contraception throughout the study period, and for 12 weeks after final study treatment administration.
13.Subject agrees not to participate in another interventional study until the End of Study (EOS) visit.

Exclusion Criteria

First 15 exclusion criteria listed:
1.Received any ESA treatment within 12 weeks prior to randomization.
2.More than one dose of IV iron within 12 weeks prior to randomization.
3.RBC transfusion within 8 weeks prior to randomization.
4.History of myelodysplastic syndrome or multiple myeloma.
5.Known hereditary hematologic disease or other known causes for anemia other than CKD.
6.Subject has a known hemosiderosis, hemochromatosis, coagulation disorder, or hypercoagulable condition.
7.Subject has chronic inflammatory disease that could impact erythropoiesis
8.Subject is anticipated to have elective surgery that is expected to lead to significant blood loss or anticipated elective coronary revascularization.
9.Subject has active or chronic gastrointestinal bleeding.
10.Subject has received any prior treatment with roxadustat or a hypoxia-inducible factor Prolyl Hydroxylase Inhibitor (HIF-PHI).
11.Subject has been treated with iron-chelating agents within 4 weeks prior to randomization.
12.Subject has a history of chronic liver disease (e.g., cirrhosis or fibrosis of the liver)
13.Subject has a known New York Heart Association Class III or IV congestive heart failure.
14.Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12 weeks prior to randomization.
15.Uncontrolled hypertension

Study & Design

• Study Type: Interventional
• Study Design: Not specified