Safety and Efficacy Study for Treatment of Anemia in Newly Initiated Dialysis Patients (Himalayas)
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in patients who have just begun dialysis treatment for end stage renal disease.
Anemia of End-stage Renal Disease
Drug: Epoetin Alfa
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 3, Multicenter, Randomized, Open-Label,Active-Controlled Study of the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Incident-Dialysis Patients|
- Hemoglobin response to treatment using various FG-4592 dosing regimens. [ Time Frame: Change from Baseline hemoglobin to 24 weeks ] [ Designated as safety issue: No ]Cumulative number (%) of subjects with hemoglobin greater than or equal to 11g/dL and increase of greater than or equal to 1 g/dL from baseline up to 24 weeks.
- Hemoglobin maintenance once correction is achieved. [ Time Frame: Week 28-36 ] [ Designated as safety issue: No ]Mean change in Hb averaged over 8 weeks of treatment at Weeks 28-36, without rescue therapy within 6 weeks prior to and during this 8 week evaluation period.
- Average monthly IV iron use per subject [ Time Frame: Weeks 1 up to 156 weeks. ] [ Designated as safety issue: No ]Average monthly IV iron use per subject
- Mean change in low-density lipoprotein (LDL) cholesterol [ Time Frame: Weeks 12-24 ] [ Designated as safety issue: No ]
- Cumulative number (%) of patients with with exacerbation of hypertension. [ Time Frame: Change in blood pressure from baseline up to weeks 156. ] [ Designated as safety issue: Yes ]At least one of the following criteria must be met in order to be considered an exacerbation of hypertension: an increase in anti-hypertensive medication use; an adverse event of hypertension or an increase in blood-pressure from baseline confirmed by repeat measurement.
- Time to achieve Hemoglobin response [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]Time to achieve first Hb response as defined by the primary endpoint.
- Change in the Health-related quality of life (HRQoL) [ Time Frame: Weeks 12, 28 and 52. ] [ Designated as safety issue: No ]Health-related quality of life (HRQoL) will be assessed using the SF-36, vitality and physical functioning subscales. Both within-treatment and between-treatment effect will be assessed.
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: FG-4592 (Roxadustat)
FG-4592 (Roxadustat) will be dosed orally three times a week. The initial dose is based on weight. Thereafter, dosages will be adjusted based on Hb values and rate of change compared to previous Hb values.
Other Name: Roxadustat
Active Comparator: Epoetin alfa
Epoetin alfa will be dispensed per the package insert or the country-specific product labeling.
Drug: Epoetin Alfa
Other Name: Procrit, Epogen
There is a screening period of up to 6 weeks, a treatment period of a minimum of 52 weeks and a maximum of approximately 3 years after last patient is randomized, and a post-treatment follow-up period of 4 weeks. A total of up to 750 patients will be randomized in a 1:1 ratio to receive either open-label FG-4592 or Active Control (Epoetin alfa).
|Contact: Clinical Trial Coordinator||415-978-1200 ext email@example.com|
|Krasnodar, Russian Federation, 350029|
|Novorossiysk, Russian Federation, 353915|
|Omsk, Russian Federation, 644112|
|Orenburg, Russian Federation, 460040|
|St. Petersburg, Russian Federation, 197110|
|St. Petersburg, Russian Federation, 196247|