CompletedPhase 3

Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis

United States2,781 participantsStarted 2014-06-26

Plain-language summary

The purpose of the study is to evaluate the safety and efficacy of roxadustat for treatment of anemia in patients with chronic kidney disease not on dialysis

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. Provision of informed consent prior to any study specific procedures.
✓. Age ≥18 years at screening visit 1
✓. eGFR \<60 mL/min/1.73 m2, (calculated by central lab) corresponding to stage 3, 4 or 5CKD according to the Kidney Disease Outcomes Quality Initiative (KDOQI), not receiving dialysis
✓. Mean of 2 most recent central laboratory Hb values during the screening period, obtained at least 7 days apart, must be \<10.0 g/dL
✓. Ferritin ≥50 ng/mL at randomization (obtained from screening visit)
✓. TSAT ≥15 % at randomization (obtained from screening visit)
✓. Serum folate level ≥ lower limit of normal (LLN) at randomization (obtained from screening visit)
✓. Serum vitamin B12 level ≥LLN at randomization (obtained from screening visit)

Exclusion criteria

✕. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
✕. Previous randomization in the present study
✕. Any erythropoietin analogue treatment within 6 weeks of randomization
✕. New York Heart Association Class III or IV congestive heart failure at enrollment
✕. Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or a thrombotic/thromboembolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization
✕. History of chronic liver disease (e.g., chronic infectious hepatitis, chronic auto- immune liver disease, cirrhosis or fibrosis of the liver)
✕. Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD
✕. Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis)

What they're measuring

Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52

Timeframe: Baseline (Day 1, Week 0) and Week 28 to Week 52.

Trial details

NCT IDNCT02174627

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10-04

Results submitted2019-10-04

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