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
  Purpose

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.


Condition Intervention Phase
Anemia of End-stage Renal Disease
Drug: FG-4592
Drug: Epoetin Alfa
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 750
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)
Arms Assigned Interventions
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.
Drug: FG-4592
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

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT02052310

Contacts
Contact: Clinical Trial Coordinator 415-978-1200 ext 1672 063study@fibrogen.com

Locations
Bulgaria
Investigational site Recruiting
Dobrich, Bulgaria, 9300
Investigational site Recruiting
Pazardjik, Bulgaria, 4400
Investigational site Recruiting
Pernik, Bulgaria, 2300
Investigational site Recruiting
Ruse, Bulgaria, 7000
Investigational site Recruiting
Sofia, Bulgaria, 1431
Korea, Republic of
Investigational site Recruiting
Goyang-Si, Gyeonggi-do, Korea, Republic of, 410-719
Russian Federation
Investigational Site Recruiting
Krasnodar, Russian Federation, 350029
Investigational Site Recruiting
Novorossiysk, Russian Federation, 353915
Investigational site Recruiting
Omsk, Russian Federation, 644112
Investigational Site Recruiting
Orenburg, Russian Federation, 460040
Investigational site Recruiting
St. Petersburg, Russian Federation, 196247
Investigational Site Recruiting
St. Petersburg, Russian Federation, 197110
Sponsors and Collaborators
FibroGen
Astellas Pharma Europe B.V.
AstraZeneca
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT02052310     History of Changes
Other Study ID Numbers: FGCL-4592-063, 2013-002753-30
Study First Received: January 6, 2014
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Estonia: The State Agency of Medicine
Belarus: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
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
Romania: Ministry of Public Health
Latvia: State Agency of Medicines
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

Keywords provided by FibroGen:
Anemia
Chronic Kidney Disease
hemoglobin
End-Stage Renal Disease
Incident-Dialysis
Erythropoetin
Erythropoeisis stimulating-agent
ASP1517

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014