Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.
Source: ClinicalTrials.gov NCT02174731 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 |
0.77; 0.68 | <0.001 sig |
| SECONDARY Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8-Week Evaluation Period |
0.88; 0.74 | <0.001 sig |
| SECONDARY Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52 |
0.79; 0.76 | <0.001 sig |
| SECONDARY Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52 |
0.65; 0.63 | <0.001 sig |
| SECONDARY Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24 |
-0.38; -0.05 | <0.001 sig |
| SECONDARY Mean Change in Hb From Baseline to the Participant's Mean Level Between Week 28 to Week 52 in Participants With Baseline High-Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN) |
0.80; 0.59 | <0.001 sig |
| SECONDARY Mean Monthly IV Iron Use From Week 36 to End of Study (EOS) |
58.71; 91.37 | <0.0001 sig |
| SECONDARY Time-To-First Administration of RBC Transfusion as Rescue Therapy |
6.0; 7.2 | <0.001 sig |
Eligibility Criteria
Inclusion criteria
- Provision of Informed Consent prior to any study specific procedures
- Age ≥18 years at screening visit 1
- Previous versions of the protocol prior to US amendment ver 6.0 and outside of US amendment ver 7.0:
Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease (ESRD) at least 30 days prior to visit 1. Patients treated with hemodialysis must have access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter. Patients on peritoneal dialysis must have a functioning peritoneal dialysis catheter in place.
Starting with US amendment ver. 6.0 and outside of US amendment ver 7.0 (changed to recruit incident dialysis patients only):
Receiving or initiating hemodialysis or peritoneal dialysis for treatment of native kidney end-stage renal disease (ESRD) for a minimum of 2 weeks and a maximum of 4 months prior to randomization. Patients treated with hemodialysis must have access consisting of an arteriovenous fistula, AV graft, or tunneled (permanent) catheter. Patients on peritoneal dialysis must have a functioning peritoneal dialysis catheter in place.
- Two central laboratory Hb values during the screening period, obtained at least 7 days apart, must be <12 g/dL in patients currently treated with an erythropoietin analogue or <10 g/dL in patients not currently treated with an erythropoietin analogue. Patients are considered not currently treated if they have not received either Mircera® for at least 8 weeks or any other erythropoietin analogue for at least 4 weeks prior to visit 1.
- Ferritin ≥100 ng/mL at randomization (obtained from screening visit)
- TSAT ≥20% 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) ≤3x 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 (prescribed dry weight)
Exclusion criteria
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- Previous randomisation in the present study
- New York Heart Association Class III or IV congestive heart failure at enrolment
- Myocardial infarction, 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.
- Uncontrolled hypertension at the time of randomization (defined as systolic BP ≥180 mmHg or diastolic BP ≥100 mmHg on repeated measurement post-dialysis in hemodialysis patients or at any time in peritoneal dialysis patients), contraindication to epoetin alfa treatment (e.g., pure red cell aplasia, hypersensitivity or know inability to tolerate epoetin alfa)
- 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 an
Data sourced from ClinicalTrials.gov (NCT02174731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.