Safety and Efficacy Study for Treatment of Anemia in Newly Initiated Dialysis Patients (Himalayas)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by FibroGen
Sponsor:
Collaborators:
Astellas Pharma Europe B.V.
AstraZeneca
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT02052310
First received: January 6, 2014
Last updated: April 15, 2014
Last verified: April 2014

January 6, 2014
April 15, 2014
December 2013
May 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02052310 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study for Treatment of Anemia in Newly Initiated Dialysis Patients
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

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.

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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia of End-stage Renal Disease
  • Drug: FG-4592
    Other Name: Roxadustat
  • Drug: Epoetin Alfa
    Other Name: Procrit, Epogen
  • 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.
    Intervention: Drug: FG-4592
  • Active Comparator: Epoetin alfa
    Epoetin alfa will be dispensed per the package insert or the country-specific product labeling.
    Intervention: Drug: Epoetin Alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
October 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Receiving hemodialysis or peritoneal dialysis for end-stage renal disease for a minimum of 2 weeks and a maximum of 4 months prior to study participation.
  • Study participant has permanent hemodialysis access in place.
  • No iron deficiency.
  • Blood tests will be conducted to determine whether or not study participant has anemia, and causes of anemia.
  • No liver disease.
  • Body weight 45 to 160 kg (dry weight).

Exclusion Criteria:

  • Any erythropoiesis-stimulating agent treatment within 12 weeks prior to participating in the study.
  • More than one dose of intravenous iron within 4 weeks prior to participating in the study.
  • Red blood cell transfusion within 8 weeks prior to participating in the study.
  • Active infection.
  • Congestive heart failure.
  • Heart attack, stroke, or blood-clots within 12 weeks prior to participating in the study.
  • Uncontrolled hypertension within 2 weeks prior to participating in the study.
  • Renal ultrasound performed within 12 weeks prior to participating in the study suspicious of renal cancer.
  • Active cancer.
  • Positive for human immunodeficiency virus (HIV); hepatitis B or hepatitis C.
  • Chronic inflammatory disease that could cause anemia.
  • Known and untreated damage to the retina from diabetes.
  • Known history of blood-related diseases causing anemia, or blood-related cancer.
  • Known inherited disease such as thalassemia or sickle cell anemia or other known causes for anemia other than chronic kidney disease.
  • Known clotting disorders and iron storage disorders.
  • Any prior organ transplant (that has not been explanted) or scheduled organ transplantation.
  • Anticipated surgery that is expected to cause blood loss.
  • Known gastrointestinal bleeding.
  • Any prior treatment with FG-4592 or a hypoxia-inducible factor prolyl hydroxylase inhibitor.
  • Use of iron-binding medications within 4 weeks prior to participating in the study.
  • Known allergies to any erythropoiesis-stimulating agent.
  • Use of an investigational drug or treatment, participation in an investigational study, or presence of an expected carryover effect of an investigational treatment within 4 weeks prior to participating in the study.
  • Anticipated use of dapsone in any dose amount or chronic use of acetaminophen or paracetomol greater than 2.0 g/day during the treatment of follow-up periods of the study.
  • History of alcohol or drug abuse within 2 years prior to participating in the study.
  • Women who can become pregnant must use contraception. Men with sexual partners who can become pregnant must use birth control unless the man agrees to contraception.
  • Pregnant or breast-feeding women.
Both
18 Years and older
No
Contact: Clinical Trial Coordinator 415-978-1200 ext 1672 063study@fibrogen.com
Bulgaria,   Korea, Republic of,   Russian Federation
 
NCT02052310
FGCL-4592-063, 2013-002753-30
Yes
FibroGen
FibroGen
  • Astellas Pharma Europe B.V.
  • AstraZeneca
Not Provided
FibroGen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP