Clinical Trials List
2015-01-01 - 2017-12-31
Phase III
Study ended12
ICD-10N18
Chronic kidney disease (CKD)
ICD-10N18.9
Chronic kidney disease, unspecified
ICD-9581.9
Nephrotic syndrome with unspecified pathological lesion in kidney
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
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Trial Applicant
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Sponsor
AstraZeneca
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- Yao-Ping Lin Division of Nephrology
The Actual Total Number of Participants Enrolled
2 Study ended
Audit
None
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
Co-Principal Investigator
- Mei-Yi Wu Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Study ended
Audit
None
Co-Principal Investigator
- Guan-Hsing Chen Division of Nephrology
- Yung-Chang Chen Division of Nephrology
The Actual Total Number of Participants Enrolled
4 Study ended
Audit
None
Co-Principal Investigator
- Yen-Cheng Chen Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Study ended
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Major adverse CV events (MACE): Time to first
occurrence of all cause mortality, non-fatal
myocardial infarction (MI) or non-fatal stroke
Secondary Endpoints:
1. Mean change in Hb from baseline to the end of
treatment period
Proportion of total time of Hb measurements
within the interval of 11±1 g/dL from week 28
until end of treatment visit
2. MACE+: Time to first occurrence of all cause
mortality, non-fatal MI or non-fatal stroke, heart
failure requiring hospitalization or unstable angina
leading to hospitalization
3. Time to first occurrence of all cause mortality, nonfatal MI, non-fatal stroke, heart failure requiring
hospitalization, unstable angina leading to
hospitalization, deep vein thrombosis, pulmonary
embolism, vascular access thrombosis or
hypertensive emergency
4. Time-to-first instance of receiving intravenous (IV)
iron, red blood cell (RBC) transfusions or
erythropoietin analogue as rescue therapy
5. Change in eGFR from baseline to the end of
treatment period
6. Changes in anemia symptoms and four diseasespecific HRQoL domains as measured by the
FACT-An
Changes in generic HRQoL as measured by the
SF-36 (vers 2, standard)
7. Changes in self-reported health status as measured
by the EQ-5D-5L and PGIC
8. Adverse events (AEs), serious adverse events
(SAEs)
Changes in vital signs, electrocardiogram (ECG)
and laboratory values
Inclution Criteria
2. Age ≥18 years at screening visit 1
3. 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
4. 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
5. Ferritin ≥50 ng/mL at randomization (obtained from screening visit)
6. TSAT ≥15 % at randomization (obtained from screening visit)
7. Serum folate level ≥ lower limit of normal (LLN) at randomization (obtained from
screening visit)
8. Serum vitamin B12 level ≥LLN at randomization (obtained from screening visit)
9. 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)
10. Body weight 45 to 160 kg
Exclusion Criteria
AstraZeneca staff and/or staff at the study site)
2. Previous randomization in the present study
3. Any erythropoietin analogue treatment within 6 weeks of randomization
4. New York Heart Association Class III or IV congestive heart failure at enrollment
5. Myocardial infarction (MI), acute coronary syndrome, stroke, seizure or
athrombotic/ thromboembolic event (e.g., deep vein thrombosis or pulmonary
embolism) within 12 weeks prior to randomization
6. History of chronic liver disease (e.g., chronic infectious hepatitis, chronic
autoimmune liver disease, cirrhosis or fibrosis of the liver)
7. 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
8. Known and untreated retinal vein occlusion or known and untreated proliferative
diabetic retinopathy (risk for retinal vein thrombosis)
9. 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
scanor MRI) conducted at screening or within 12 weeks prior to randomization
10. 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
11. 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
12. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis
Bsurface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
13. Chronic inflammatory diseases such as rheumatoid arthritis, SLE, ankylosing
spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to
be the principal cause of anemia
14. Known hemosiderosis, hemochromatosis or hypercoagulable condition
15. Any prior organ transplant or a scheduled organ transplantation date
16. Any red blood cell transfusion (RBC) during the screening period
17. Any current condition leading to active significant blood loss
18. Any treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase
inhibitor (HIF-PHI)
19. 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)
20. History of alcohol or drug abuse within 2 years prior to randomization
21. Females of childbearing potential, unless using contraception as detailed in the
protocol or sexual abstinence (see Protocol Section 3.8)
22. Pregnant or breastfeeding females
23. Known allergy to the investigational product or any of its ingredients
24. 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 safety or efficacy assessment or may interfere with
study participation
The Estimated Number of Participants
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Taiwan
260 participants
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Global
2600 participants
