CompletedPhase 2

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

United States, Puerto Rico145 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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Chronic Kidney Disease trials