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A Study of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not Receiving Dialysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by FibroGen
Sponsor:
Collaborators:
Astellas Pharma Europe B.V.
AstraZeneca
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01750190
First received: December 11, 2012
Last updated: February 29, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in chronic kidney disease patients who are not on dialysis.

Condition Intervention Phase
CKD Anemia
Drug: FG-4592
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • Efficacy of roxadustat (FG-4592) for the treatment of anemia correction and maintenance [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Efficacy of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance (as defined in protocol) in CKD subjects not on dialysis


Secondary Outcome Measures:
  • Effect of roxadustat (FG-4592) on serum lipid parameters [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    Change in low-density lipoprotein (LDL) cholesterol.

  • Effect of roxadustat (FG-4592) on patient reported outcomes [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    Evaluate health-related quality of life benefits, as measured by the 36-Item Short Form Health Survey (SF-36)

  • Evaluate the need for anemia rescue therapy, such as IV Iron, blood transfusion or injectable ESA [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Proportion of patients who received rescue therapy (composite of RBC transfusion, ESA use, and IV iron)

  • Effect of roxadustat (FG-4592) on blood pressure [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change in mean arterial pressure and effect on reducing hypertension

  • Safety of roxadustat (FG-4592) [ Time Frame: Minimum of 52 weeks ] [ Designated as safety issue: Yes ]
    Adverse events, serious adverse events, vital signs, electrocardiograms and physical exams


Estimated Enrollment: 600
Study Start Date: November 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FG-4592 (Double-blind, Three times a week)
Weight-based starting doses of 70mg or 100mg; dose adjustments to hemoglobin levels are allowed during the study.
Drug: FG-4592
Oral
Other Name: Roxadustat; ASP1517; AZD9941
Placebo Comparator: Placebo (Double-blind, Three times a week)
Weight-based starting doses of 70mg or 100mg; dose adjustments to hemoglobin levels are allowed during the study.
Drug: Placebo
Oral
Other Name: Roxadustat; ASP1517; AZD9941

Detailed Description:
There is a screening period of up to 6 weeks, a variable treatment period for individual subjects with a minimum treatment duration of 52 weeks and a maximum treatment duration of time to enroll all subjects plus 52 weeks after the last subject is randomized, and a post-treatment follow-up period of 4 weeks. A total of 600 patients will be randomized in a 2:1 ratio to receive either roxadustat (FG-4592-approximately 400 subjects) or placebo (approximately 200 subjects) in a double-blind manner.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic kidney disease, Stage 3, 4, or 5, not receiving dialysis
  • Anemia qualified by measurements of hemoglobin values during screening
  • Additional blood work must be in a safe range for study entry
  • Body weight 45 to 160 kg
  • Willingness to use contraception if of child-bearing potential

Exclusion Criteria:

  • Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
  • More than one dose of intravenous iron within 12 weeks prior to study participation
  • Blood transfusion within 8 weeks prior to study participation
  • Active infection
  • Chronic liver disease
  • Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
  • Uncontrolled blood pressure within 2 weeks prior to study participation
  • Renal cell carcinoma
  • History of malignancy, including multiple myeloma or other myelodysplastic syndrome
  • Chronic inflammatory disease that could impact red blood cell production
  • Any prior organ transplant, or a scheduled organ transplantation
  • Anticipated elective surgery that is expected to lead to significant blood loss, or anticipated elective heart procedure
  • Gastrointestinal bleeding
  • Any prior treatment with FG-4592 or a HIF-PHI
  • Recent use of an investigational drug or treatment, or participation in an investigational study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750190

Contacts
Contact: Charles Bradley, PhD 1-415-978-1672 060study@fibrogen.com

  Show 166 Study Locations
Sponsors and Collaborators
FibroGen
Astellas Pharma Europe B.V.
AstraZeneca
Investigators
Study Chair: Peony Yu, MD FibroGen
  More Information

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01750190     History of Changes
Other Study ID Numbers: FGCL-4592-060 
Study First Received: December 11, 2012
Last Updated: February 29, 2016
Health Authority: United States: Food and Drug Administration
Malaysia: Ministry of Health
Taiwan : Food and Drug Administration
Korea: Ministry of Food and Drug Safety
Hong Kong: Department of Health
Thailand: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Australia: Department of Health and Ageing Therapeutic Goods Administration
Singapore: Health Sciences Authority
Philippines : Food and Drug Administration
New Zealand: Ministry of Health

Keywords provided by FibroGen:
anemia
chronic kidney disease (CKD)
non-dialysis
Hemoglobin (Hb)
End-Stage Renal Disease
erythropoeitin
ASP1517
erythropoeisis stimulating-agent
AZD9941

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on December 09, 2016