A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and… (NCT01750190) | Clinical Trial Compass
CompletedPhase 3
A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis
United States922 participantsStarted 2012-11-05
Plain-language summary
The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Chronic kidney disease Stages 3, 4, or 5 and not receiving dialysis
* Anemia qualified by measurements of hemoglobin values during screening
* Additional blood work must be in a safe range for study entry
* Body weight 45 to 160 kilograms (kg)
* Willingness to use contraception if of child-bearing potential
Exclusion Criteria:
* Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
* More than 1 dose of intravenous iron within 12 weeks prior to study participation
* Blood transfusion within 8 weeks prior to study participation
* Active infection
* Chronic liver disease
* Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
* Uncontrolled blood pressure within 2 weeks prior to study participation
* Renal cell carcinoma
* History of malignancy, including multiple myeloma or other myelodysplastic syndrome
* Chronic inflammatory disease that could impact red blood cell production
* Any prior organ transplant or a scheduled organ transplantation
* Anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure
* Gastrointestinal bleeding
* Any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
* Recent use of an investigational drug or treatment, or participation in an investigational study
What they're measuring
1
United States (US FDA) Submission: Mean Change From Baseline in Hb (g/dL) Over Weeks 28 to 52 Regardless of Rescue Therapy
Timeframe: Baseline (Day 1, Week 0), Weeks 28 to 52
2
Ex-US Submission: Number (%) of Participants Who Achieved a Hb Response During the First 24-Weeks of Treatment Censoring for Rescue Therapy