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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 firstname.lastname@example.org|
|Principal Investigator: Hong Liu, MD,phD|