Resumen

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

Descripción detallada

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in anemic patients with Stage 3, 4 or 5 chronic kidney disease (CKD) who are not on dialysis.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 130 YearsSexo: ALL

Criterios de inclusión

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)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) and total bilirubin (Tbili) ≤1.5 x ULN at randomization (obtained from screening visit)
Body weight 45 to 160 kg

Criterios de exclusión

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)
Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening or within 12 weeks prior to randomization
Systolic BP ≥160 mmHg or diastolic BP ≥95 mmHg (confirmed by repeated measurement), within 2 weeks prior to randomization. Patients may be rescreened once BP controlled
History of prostate cancer, breast cancer or any other malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia
Known hemosiderosis, hemochromatosis or hypercoagulable condition
Any prior organ transplant or a scheduled organ transplantation date
Any red blood cell transfusion (RBC) during the screening period
Any current condition leading to active significant blood loss
Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)
Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 1 month of the first administration of IP in this study. (Note: patients consented and screened, but not randomized in this study or a previous study are not excluded)
History of alcohol or drug abuse within 2 years prior to randomization
Females of childbearing potential, unless using contraception as detailed in the protocol or sexual abstinence
Pregnant or breastfeeding females
Known allergy to the investigational product or any of its ingredients
Any medical condition, including active, clinically significant infection, that in the opinion of the investigator or Sponsor may pose a safety risk to a patient in this study, which may confound efficacy or safety assessment or may interfere with study participation

Ubicaciones

Research Site

CABA, Argentina

Research Site

CABA, Argentina

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Capital Federal, Argentina

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Ciudad Autónoma de Bs. As., Argentina

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Ciudadela, Argentina

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La Plata, Argentina

Research Site

La Plata, Argentina

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Lanús, Argentina

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Mar del Plata, Argentina

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Munro, Argentina

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Ramos Mejía, Argentina

Research Site

Rosario, Argentina

Research Site

Rosario, Argentina

Research Site

San Isidro, Argentina

Research Site

San Miguel de Tucumán, Argentina

Research Site

Santa Rosa, Argentina

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Roxadustat for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Roxadustat

Placebo

Ubicaciones

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Patrocinadores