Safety and Efficacy Study for Treatment of Anemia in ESRD Newly Initiated Dialysis Patients (Himalayas)
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|ClinicalTrials.gov Identifier: NCT02052310|
Recruitment Status : Recruiting
First Posted : February 3, 2014
Last Update Posted : May 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anemia in Incident Dialysis Patients||Drug: FG-4592 (roxadustat) Drug: Epoetin Alfa||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3, Multicenter, Randomized, Open-Label,Active-Controlled Study of the Efficacy and Safety of FG-4592 (Roxadustat) in the Treatment of Anemia in Incident-Dialysis Patients|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: FG-4592 (roxadustat)
FG-4592 (roxadustat) will be dosed orally three times a week.
Drug: FG-4592 (roxadustat)
Drug will be dosed orally three times a week.
Active Comparator: Epoetin alfa
Epoetin alfa will be dispensed 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: Procrit, Epogen
- U.S.A.: Mean Hemoglobin (Hb) change from baseline to average levels from Week 28 to Week 52. Ex-U.S.A.: Proportion of subjects who achieve a Hb response during the first 24 weeks of treatment. [ Time Frame: Minimum of 52 weeks and maximum of up to 3 years after last subject is randomized. ]
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.
- U.S.A.: Proportion of subjects who achieve a Hemoglobin (Hb) response during the first 24 weeks of treatment. Ex-U.S.A.: Mean Hb change from baseline to average levels from Week 28 to Week 52. [ Time Frame: Varies based on Ex-U.S.A. vs. U.S.A. submission ]
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.
- Use of Iron [ Time Frame: week 0 -End of Treatment ]Average monthly IV iron use per subject during the Treatment Period.
- Serum lipid parameters [ Time Frame: Weeks 12-24 ]Mean change in low-density lipoprotein (LDL) cholesterol.
- Blood pressure effects [ Time Frame: Treatment Period; Weeks 8-12 ]
Proportions of patients with exacerbation of hypertension, meeting at least one of the following criteria:
- An increase from baseline in sBP of ≥ 20 mm Hg and sBP >170 mmHg, or
- An increase from baseline in dBP of ≥ 15 mm Hg and dBP>100 mmHg. Increases in blood pressure must be confirmed by repeat measurement. Time to an increase in blood pressure as defined above Mean change in mean arterial pressure (MAP) averaged over Weeks 8-12.
- Time to achieve Hemoglobin (Hb) response [ Time Frame: Varies based on U.S.A. vs. Ex-U.S.A. submission ]Time to achieve first Hb response as defined by the primary endpoint (ex-U.S.A.) and secondary endpoint (U.S.A).
- Health-related quality of life (HRQoL) [ Time Frame: Weeks 12, 36, 52 and EOT ]Health-related quality of life (HRQoL) will be assessed using the SF-36 FACT-AN and EQ-5D-5L questionnaires
- Additional efficacy analysis [ Time Frame: Treatment weeks up to EOT ]Hemoglobin correction and maintenance, rescue therapy, hospitalizations, other additional labs of interest.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052310
|Contact: Trial Coordinator||415-978-1200 ext email@example.com|
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|Study Director:||Charles Bradley, PhD||FibroGen|