CompletedPhase 2

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

United States145 participantsStarted 2010-10-29

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age 18 to 75 years
✓. Chronic kidney disease, not receiving dialysis
✓. Body weight 45 to 140 kg

Exclusion criteria

✕. Any clinically significant infection or evidence of an underlying infection
✕. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
✕. History of chronic liver disease
✕. New York Heart Association Class III or IV congestive heart failure
✕. Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
✕. History of malignancy
✕. Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
✕. History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia

What they're measuring

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

Timeframe: Up to Week 17

Trial details

NCT IDNCT01244763

SponsorKyntra Bio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-06-13

Results submitted2021-09-01

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