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Trial record 1 of 1 for:    FGCL-4592 | Bakersfield, California, U.S.
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Efficacy and Safety of FG-4592 for Treatment of Anemia in Patients With Lower Risk MDS With Low Red Blood Cell Transfusion Burden

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ClinicalTrials.gov Identifier: NCT03263091
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : December 12, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
FibroGen

Brief Summary:
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood Cell Transfusion Burden.

Condition or disease Intervention/treatment Phase
Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts) Drug: FG-4592 Drug: Placebo Phase 3

Detailed Description:
This study includes an Open-Label and a Double-Blind component. In each, there is an up to 28 days screen period followed by a treatment period of 52 weeks and a 4 week end of treatment assessment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2021


Arm Intervention/treatment
Experimental: FG-4592 (Open Label, Double-blind, Three times a week)
Weight-based starting doses; dose adjustments to hemoglobin levels are allowed during the study.
Drug: FG-4592
Oral
Other Names:
  • Roxadustat
  • ASP1517
  • AZD9941

Placebo Comparator: Placebo (Double-blind, Three times a week)
Weight-based starting doses; dose adjustments to hemoglobin levels are allowed during the study.
Drug: Placebo
Oral




Primary Outcome Measures :
  1. Efficacy of roxadustat (FG-4592) to achieve transfusion independence ≥ 56 consecutive days [ Time Frame: 28 weeks ]
    Efficacy of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance and reducing the number of red blood cell packs transfused in 28 weeks in comparison to baseline


Secondary Outcome Measures :
  1. Evaluate the incidence of treatment emergent adverse events of roxadustat [ Time Frame: 52 weeks ]
    Adverse events, serious adverse events, vital signs, electrocardiograms, blood pressure, heart rate, and physical exams

  2. Evaluate the impact of roxadustat on RBC transfusion requirements [ Time Frame: 52 weeks ]
    Impact of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance and reducing the number of red blood cell packs transfused throughout the course of the study in comparison to baseline

  3. Effect of roxadustat on quality of life parameters, as measured by PROMIS and EQ-5D-5L assessment [ Time Frame: 52 weeks ]
    Change in raw score from baseline in Physical Function (PF) and Fatigue score as measured by Patient-Reported Outcome Measurement Information System (PROMIS). And change in raw score from baseline in the EuroQol Quality of Life Five Dimensional Five Level Health Questionnaire (EQ-5D-5L) assessment.

  4. Evaluate transfusion independence ≥ 56 consecutive days [ Time Frame: 52 weeks ]
    Evaluate transfusion independence by measuring the number of red blood cell packs transfused throughout the course of the study in comparison to baseline


Other Outcome Measures:
  1. Duration of transfusion independence [ Time Frame: 52 weeks ]
    Evaluate transfusion independence by measuring the number of red blood cell packs transfused throughout the course of the study in comparison to baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Diagnosis of primary MDS classified as very low, low or intermediate risk with <5% blasts. There is no minimum time from diagnosis except to allow for proper IPSS-R classification to be made, and to show transfusion dependence.
  • RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization
  • No restriction on prior use of ESAs, except no ESA use within 8 weeks prior to registration/randomization
  • Pre-transfusion hemoglobin of <= 10 g/dL,
  • ECOG of 0-2 at screen
  • History of cured malignancy with no evidence of recurrence for a least 3 years are eligible

Key Exclusion Criteria:

  • Diagnosis of secondary MDS
  • Significant myelofibrosis (>2+fibrosis)
  • MDS associated with 5q(del) abnormality
  • Screen serum erythropoietin level > 400 mIU/mL,
  • Clinically significant anemia due to non-MDS etiologies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263091


Contacts
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Contact: Charles Bradley, PhD 1-415-978-1672 082MDSstudy@fibrogen.com
Contact: Gopal Saha, MD 082MDSstudy@fibrogen.com

Locations
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United States, California
Investigational Site Recruiting
Alhambra, California, United States, 91801
Investigational Site Recruiting
Bakersfield, California, United States, 93309
Investigational Site Recruiting
Beverly Hills, California, United States, 90212
Investigational Site Recruiting
Burbank, California, United States, 91505
Investigational Site Recruiting
Encino, California, United States, 91436
Investigational Site Recruiting
Irvine, California, United States, 92604
Investigational Site Recruiting
Laguna Hills, California, United States, 92653
Investigational Site Withdrawn
Los Angeles, California, United States, 90095-6984
Investigational Site Recruiting
Los Angeles, California, United States, 90095
Investigational Site Recruiting
Los Angeles, California, United States, 91326
Investigational Site Withdrawn
Oceanside, California, United States, 92056
Investigational Site Recruiting
Pasadena, California, United States, 91105
Investigational Site Recruiting
Santa Maria, California, United States, 93454
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Santa Rosa, California, United States, 95403
Investigational Site Recruiting
Torrance, California, United States, 90505
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Valencia, California, United States, 91355
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Ventura, California, United States, 93003
Investigational Site Recruiting
Westlake Village, California, United States, 91361
Investigational Site Recruiting
Whittier, California, United States, 90603
United States, Florida
Investigational Site Recruiting
Pembroke Pines, Florida, United States, 33028
Investiational Site Not yet recruiting
Weston, Florida, United States, 33331
United States, Georgia
Investgational site Not yet recruiting
Atlanta, Georgia, United States, 30322
United States, Missouri
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Saint Louis, Missouri, United States, 63110
United States, Ohio
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Canton, Ohio, United States, 44718
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Cleveland, Ohio, United States, 44111
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Cleveland, Ohio, United States, 44195
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Mayfield Heights, Ohio, United States, 44124
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
United States, Texas
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Houston, Texas, United States, 77030
Australia, New South Wales
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Darlinghurst, New South Wales, Australia, 2010
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Liverpool, New South Wales, Australia, 2170
Australia, Queensland
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South Brisbane, Queensland, Australia, 4101
Australia, Saint Albans
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Victoria Park, Saint Albans, Australia, 3021
Australia, Tasmania
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Hobart, Tasmania, Australia, 7000
Belgium
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Wilrijk, Antwerpen, Belgium, 2610
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Bruxelles, Brussels Capital Region, Belgium, 1200
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Hasselt, Limburg, Belgium, 3500
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Brugge, West-Vlaanderen, Belgium, 8000
Germany
Investigational Site Recruiting
Freiburg, Baden-Wurttemberg, Germany, 79106
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Munchen, Bayern, Germany, 81675
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Münster, Nordrhein-Westfalen, Germany, 48149
Investigational Site Recruiting
Dresden, Sachsen, Germany, 01307
Investigational Site Recruiting
Leipzig, Sachsen, Germany, 04103
Investigational Site Withdrawn
Hamburg, Germany, 20246
Israel
Investigational Site Recruiting
Kfar Saba, HaMerkaz, Israel, 4428164
Investigational Site Recruiting
Zerifin, HaMerkaz, Israel, 70300
Investigational Site Recruiting
Nahariya, HaZafon, Israel, 22100
Investigational Site Recruiting
Haifa, Israel, 3436212
Investigational Site Recruiting
Tel Aviv, Israel, 49372
Investgational site Not yet recruiting
Tel HaShomer, Israel
Italy
Investigational Site Recruiting
Meldola, Ravenna, Italy, 47014
Investigational Site Not yet recruiting
Alessandria, Italy, 15121
Investigational Site Recruiting
Bologna, Italy, 40138
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Firenze, Italy, 50134
Investigational Site Recruiting
Genova, Italy, 16132
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Ravenna, Italy
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Rimini, Italy
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Terni, Italy, 5100
Investigational Site Not yet recruiting
Torino, Italy
Investigational Site Recruiting
Varese, Italy, 21100
Korea, Republic of
Investigational Site Recruiting
Incheon, Incheon Gwang'yeogsi, Korea, Republic of, 21565
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Incheon, Incheon Gwangyeogsi, Korea, Republic of, 21565
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Hwasun, Jeonranamdo, Korea, Republic of, 58128
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Russian Federation
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Kaluga, Russian Federation, 248007
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Moscow, Russian Federation, 111123
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Moscow, Russian Federation, 123182
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Moscow, Russian Federation, 129110
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Omsk, Russian Federation, 644013
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Saint Petersburg, Russian Federation, 191024
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Saint Petersburg, Russian Federation, 197089
Investigational Site Recruiting
Saint Petersburg, Russian Federation, 197341
Spain
Investigational Site Recruiting
Sabadell, Barcelona, Spain, 08208
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Barcelona, Catalunya, Spain, 08003
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Pamplona, Navarra, Spain, 31008
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Barcelona, Spain, 08041
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Madrid, Spain, 28034
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Madrid, Spain, 28050
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Salamanca, Spain, 37007
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Sevilla, Spain, 41009
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Sevilla, Spain, 41013
United Kingdom
Investigational Site Recruiting
Boston, Lincolnshire, United Kingdom, PE21 9QS
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Harrow, United Kingdom, HA1 3UJ
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London, United Kingdom, SE5 9RS
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Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
FibroGen
AstraZeneca
Investigators
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Study Chair: K. Peony Yu, MD FibroGen
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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT03263091    
Other Study ID Numbers: FGCL-4592-082
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FibroGen:
Myelodysplastic Syndromes
Anemia
Hemoglobin (Hb)
Low Risk Myelodysplastic Syndrome
Low Risk MDS
Additional relevant MeSH terms:
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Anemia
Myelodysplastic Syndromes
Hematologic Diseases
Bone Marrow Diseases