Evaluate the Efficacy and Safety of Roxadustat for the Treatment of Anemia and Risks of Cardiovascular and Cerebrovascular Events in ESRD Newly Initiated Dialysis Patients
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|ClinicalTrials.gov Identifier: NCT04134026|
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anemia in Incident Dialysis Patients||Drug: Roxadustat Drug: Epoetin Alfa||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 4, Multicenter, Randomized, Open-Lable, Active-Controlled Study of the Efficacy and Safty of Roxadustat for the Treatment of Anemia and Risks of Cardiovascular and Cerebrovascular Events in Incident-Dialysis Patients|
|Estimated Study Start Date :||October 20, 2019|
|Estimated Primary Completion Date :||October 19, 2020|
|Estimated Study Completion Date :||October 19, 2023|
Roxadustat will be dosed orally three times a week.
Drug will be dosed orally three times a week.
Other Name: FG-4592
Active Comparator: Epoetin alfa
Epoetin alfa wull be disoensed per the package insert or the country-specific product labeling.
Drug: Epoetin Alfa
The drug will be dispensed per the package insert or the country-specific product labeling.
Other Name: Epogen
- Mean Hemoglobin (Hb) change from baseline to average levels from Week 28 to Week 52. [ Time Frame: Minimum of 52 weeks and maximum of up to 3 years after last subject is randomized ]For participants who did not have an available Hb value during the week 28-52 period, imputation rules were applied.
- Proportion of subjects who achieve a Hb response during the first 24 weeks of treatment. [ Time Frame: Week 0 to Week 24 ]
A Hb response is defined as:
Hb ≥11.0g/dL and a Hb increase from baseline by ≥1.0g/dL in subjects whose baseline Hb >8.0g/dL, or Increase in Hb ≥2.0g/dL in subjects whose baseline Hb ≤8.0g/dL.
- The incidence of cardiovascular and cerebrovascular events within 52 weeks. [ Time Frame: Week 0 to Week 52 ]Non fatal myocardial infarction, unstable angina, coronary artery bypass, coronary or peripheral vascular intervention, hospitalization due to heart failure, transient ischemic attack, stroke and death.
- All cause mortality [ Time Frame: Minimum of 52 weeks and maximum of up to 3 years after last subject is randomized ]The incidence of death events.
- BP effect 1: the proportion of subjects with increased hypertension [ Time Frame: Week 0 to Week 27 ]Blood pressure (BP) increased compared to pre-dialysis BP: the delta systolic BP ≥ 20 mmHg and systolic blood pressure ≥ 170 mmHg, or the delta diastolic BP ≥ 15 mmHg and diastolic BP ≥ 100 mmHg.
- BP effect 2 [ Time Frame: Week 28 to Week 52 ]Mean BP change from baseline to average levels from Week 28 to Week 52.
- The change of left ventricular structure [ Time Frame: Weeks 12, 36, 52 ]Standardized ECHO evaluates left ventricular volume index (ml/m2).
- The change of left ventricular systolic function [ Time Frame: Weeks 12, 36, 52 ]Standardized ECHO evaluates left ventricular ejection fraction (%).
- The change of right ventricular systolic function [ Time Frame: Weeks 12, 36, 52 ]Systolic lateral tricuspid annulus velocity (S') was measured by tissue Doppler.
- The change of diastolic function [ Time Frame: Weeks 12, 36, 52 ]Left ventricular diastolic function was measured based on the integration of the ratio of early (E wave) and late (A wave) mitral inflow, mitral E wave deceleration time, E/e' ratio (e' being the tissue Doppler velocity of the medial annulus), E/A changes with Valsalva maneuver, and pattern of pulmonary vein flow. The data will be combine to report diastolic function.
- Serum lipid parameters [ Time Frame: Week 25 to Week 27 ]Mean change in low-density lipoprotein (LDL) cholesterol.
- Inflammatory evaluation 1 [ Time Frame: Week 25 to Week 27 ]Mean change level of CRP.
- Inflammatory evaluation 2 [ Time Frame: Week 25 to Week 27 ]Mean change level of IL-2
- Inflammatory evaluation 3 [ Time Frame: Week 25 to Week 27 ]Mean change level of IL-6
- Inflammatory evaluation 4 [ Time Frame: Week 25 to Week 27 ]Mean change level of IL-17A
- Serum iron level [ Time Frame: Week 0 to Week 27 ]Mean change of iron from baseline to level at the 27th week.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04134026
|Department of Nephrology, Second Xiangya Hospital, Central South University||Recruiting|
|Changsha, Hunan, China, 410000|
|Contact: Hong Liu, MD,phD 86-0731-85292057 email@example.com|
|Principal Investigator: Hong Liu, MD,phD|