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 January 2014 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: January 31, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the safety and efficacy of FG-4592 in the treatment of anemia of Chronic Kidney Disease (CKD).


Condition Intervention Phase
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 FG-4592 - anemia correction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Efficacy of FG-4592 in achieving hemoglobin response (as defined in protocol) in CKD subjects not receiving dialysis


Secondary Outcome Measures:
  • Efficacy of FG-4592 - Maintenance of hemoglobin levels [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Evaluate the need for anemia rescue therapy, such as blood transfusion, intravenous Iron, or injectable erythrocyte stimulating therapies [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Safety of FG-4592 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Evaluate changes in vital signs and laboratory values

  • FG-4592 Tolerability [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Evaluate Adverse Events (AE) and Serious Adverse Events (SAE)


Estimated Enrollment: 450
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FG-4592 (TIW & BIW)
Study drug will be dosed TIW during the correction period, then twice weekly (BIW) during the maintenance period. Dose adjustments are allowed during the study.
Drug: FG-4592
Oral
Other Name: Roxadustat; ASP1517
Placebo Comparator: Placebo (TIW & TIW)
Study drug will be dosed TIW during the correction period and TIW during the maintenance period. Dose adjustments are allowed during the study.
Drug: Placebo
Oral
Experimental: FG-4592 (TIW & TIW)
Study drug will be dosed three times weekly (TIW) during the correction period and TIW during the maintenance period. Dose adjustments are allowed during the study.
Drug: FG-4592
Oral
Other Name: Roxadustat; ASP1517
Experimental: FG-4592 (TIW & QW)
Study drug will be dosed TIW during the correction period, then weekly (QW) during the maintenance period. Dose adjustments are allowed during the study.
Drug: FG-4592
Oral
Other Name: Roxadustat; ASP1517
Placebo Comparator: Placebo (TIW & BIW)
Study drug will be dosed TIW during the correction period and BIW during the maintenance period. Dose adjustments are allowed during the study.
Drug: Placebo
Oral
Placebo Comparator: Placebo (TIW & QW)
Study drug will be dosed TIW during the correction period and QW during the maintenance period. Dose adjustments are allowed during the study.
Drug: Placebo
Oral

Detailed Description:

There is a screening period of up to 6 weeks, a treatment period of 52 weeks, and a post-treatment follow up period of 4 weeks. A total of 450-600 patients will be randomized in a 2:1 ratio to receive either FG-4592 or Placebo in blinded fashion.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 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: Clinical Trial Coordinator 1-415-978-1672 060study@fibrogen.com

Locations
United States, California
Investigational Site Recruiting
Chula Vista, California, United States, 91910
Investigational Site Recruiting
Northridge, California, United States, 91325
Investigational Site Withdrawn
Riverside, California, United States, 92505
Investigational Site Terminated
Yuba City, California, United States, 95991
Argentina
Investigational site Not yet recruiting
Cordoba, Argentina
Australia
Investigational Site Recruiting
Sydney, Australia
Brazil
Investigational site Not yet recruiting
Sao Paolo, Brazil
Hong Kong
Investigational Site Not yet recruiting
Hong Kong, Hong Kong
Korea, Republic of
Investigational Site Recruiting
Seoul, Korea, Republic of
Malaysia
Investigational Site Not yet recruiting
Selayang, Malaysia
Mexico
Investigational Site Not yet recruiting
San Luis Potosi, Mexico
New Zealand
Investigational Site Not yet recruiting
Auckland, New Zealand
Peru
Investigational site Not yet recruiting
Lima, Peru
Philippines
Investigational site Not yet recruiting
Pasig, Philippines
Singapore
Investigational Site Not yet recruiting
Singapore, Singapore
Taiwan
Investigational Site Not yet recruiting
Kaohsiung, Taiwan
Thailand
Investigational Site Not yet recruiting
Bangkok, Thailand
Sponsors and Collaborators
FibroGen
Astellas Pharma Europe B.V.
AstraZeneca
Investigators
Study Director: Charles Bradley, PhD FibroGen
  More Information

No publications provided

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: January 31, 2014
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
Brazil: National Health Surveillance Agency
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

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

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

ClinicalTrials.gov processed this record on October 20, 2014