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Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

Primary Purpose

Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts)

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Roxadustat
Placebo
Sponsored by
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts) focused on measuring Myelodysplastic Syndromes, Anemia, Hemoglobin (Hb), Low Risk Myelodysplastic Syndrome, Low Risk MDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Diagnosis of primary MDS classified by the International Prognostic Scoring System - Revised (IPSS-R) as very low, low or intermediate risk with <5% bone marrow blasts. There is no minimum time from diagnosis to registration/randomization except to allow for proper IPSS-R classification to be made (within 16 weeks prior to randomization), and to show transfusion dependence for participants in both portions of the study.
  • RBC transfusion of either 2-4 pRBC units during the 8 weeks prior to registration/randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to registration/randomization. Open-Label Lead-in participants only, the requirement to demonstrate transfusion dependence can also be met by a Principal Investigator starting this particular participant on pRBC transfusion during the screening period.
  • No restriction on prior use of recombinant erythropoietins or analogues (erythropoiesis-stimulating agents [ESAs]), except no ESA use within 8 weeks prior to Day 1 registration/randomization.
  • Hemoglobin (Hb) ≤10.0 grams/deciliter (g/dL) during screening
  • Eastern Cooperative Oncology Group (ECOG) of 0-2 at screening

Key Exclusion Criteria:

  • Diagnosis of secondary MDS associated with prior chemotherapy, extensive radiation therapy (>25% of bone marrow reserve), and or/other significant chemical or radiation exposure
  • Significant myelofibrosis (>2+ fibrosis)
  • MDS associated with 5q(del) cytogenetic abnormality
  • Screen serum erythropoietin level > 400 milli-international units (mIU)/milliliter (mL) • Clinically significant anemia, as determined by the investigator, due to non-MDS etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune or hereditary hemolysis or anemia or hemorrhage or hereditary anemia such as sickle cell anemia or thalassemia.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Roxadustat

Placebo

Arm Description

Open-label, lead-in: Participants will receive sequential escalating roxadustat doses (1.5 milligrams/kilograms [mg/kg], 2.0 mg/kg and 2.5 mg/kg), three times a week (TIW) based upon their actual weight at the randomization visit to identify the starting dose for double-blind period. Double-blind: Participants will receive roxadustat 2.5 mg/kg TIW based upon their body weight for a duration of 52 weeks. Open-label: Participants with high serum erythropoietin levels (>400 milli-international units [mIU]/milliliter [mL] mIU/mL) will receive roxadustat 2.5 mg/kg TIW based upon their body weight for a duration of 52 weeks.

Double-blind: Participants will receive placebo matching to roxadustat for a duration of 52 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants who Achieve Transfusion Independence (TI) ≥56 Consecutive Days in the First 28 Weeks of Treatment

Secondary Outcome Measures

Percentage of Participants who Achieve TI ≥56 Consecutive Days Anytime During the Study
Percentage of Participants who Achieve ≥50% Reduction From Baseline in Number of RBC Transfusion Over Any 8 Weeks
Cumulative Number of Participant-Exposure-Week of TI
Number of Packs of Red Blood Cells (pRBC) Packs Transfused Compared to Baseline
Percentage of Participants who Achieved TI for > 20 Weeks (140 Days)
Mean Change From Baseline in Physical Function as Measured by Patient Reported Outcomes Measurement Information System (PROMIS)
Mean Change From Baseline in PROMIS Fatigue Score
Mean Change From Baseline in EuroQol Quality of Life Five Dimensional Five Level Health Questionnaire (EQ-5D-5L) Assessment Score

Full Information

First Posted
August 22, 2017
Last Updated
August 10, 2023
Sponsor
FibroGen
Collaborators
AstraZeneca, Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03263091
Brief Title
Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Study did not meet its primary efficacy endpoint.
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
June 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
Collaborators
AstraZeneca, Astellas Pharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in participants with lower risk MDS and low red blood cell transfusion burden.
Detailed Description
This study includes an Open-Label Lead in, a Double-Blind component, and an Open-Label High Erythropoietin component. There is a screening period of up to 42 days followed by a treatment period of 52 weeks and a 4-week end of treatment assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts)
Keywords
Myelodysplastic Syndromes, Anemia, Hemoglobin (Hb), Low Risk Myelodysplastic Syndrome, Low Risk MDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roxadustat
Arm Type
Experimental
Arm Description
Open-label, lead-in: Participants will receive sequential escalating roxadustat doses (1.5 milligrams/kilograms [mg/kg], 2.0 mg/kg and 2.5 mg/kg), three times a week (TIW) based upon their actual weight at the randomization visit to identify the starting dose for double-blind period. Double-blind: Participants will receive roxadustat 2.5 mg/kg TIW based upon their body weight for a duration of 52 weeks. Open-label: Participants with high serum erythropoietin levels (>400 milli-international units [mIU]/milliliter [mL] mIU/mL) will receive roxadustat 2.5 mg/kg TIW based upon their body weight for a duration of 52 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Double-blind: Participants will receive placebo matching to roxadustat for a duration of 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Roxadustat
Other Intervention Name(s)
FG-4592, ASP1517, AZD9941
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Percentage of Participants who Achieve Transfusion Independence (TI) ≥56 Consecutive Days in the First 28 Weeks of Treatment
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve TI ≥56 Consecutive Days Anytime During the Study
Time Frame
Weeks 28 and 52
Title
Percentage of Participants who Achieve ≥50% Reduction From Baseline in Number of RBC Transfusion Over Any 8 Weeks
Time Frame
Weeks 28 and 52
Title
Cumulative Number of Participant-Exposure-Week of TI
Time Frame
Weeks 28 and 52
Title
Number of Packs of Red Blood Cells (pRBC) Packs Transfused Compared to Baseline
Time Frame
Weeks 28 and 52
Title
Percentage of Participants who Achieved TI for > 20 Weeks (140 Days)
Time Frame
Weeks 28 and 52
Title
Mean Change From Baseline in Physical Function as Measured by Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame
Baseline, Weeks 9, 17, 28, 52 and 56
Title
Mean Change From Baseline in PROMIS Fatigue Score
Time Frame
Baseline, Weeks 9, 17, 28, 52 and 56
Title
Mean Change From Baseline in EuroQol Quality of Life Five Dimensional Five Level Health Questionnaire (EQ-5D-5L) Assessment Score
Time Frame
Baseline, Weeks 9, 17, 28, 52 and 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosis of primary MDS classified by the International Prognostic Scoring System - Revised (IPSS-R) as very low, low or intermediate risk with <5% bone marrow blasts. There is no minimum time from diagnosis to registration/randomization except to allow for proper IPSS-R classification to be made (within 16 weeks prior to randomization), and to show transfusion dependence for participants in both portions of the study. RBC transfusion of either 2-4 pRBC units during the 8 weeks prior to registration/randomization or 1 pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to registration/randomization. Open-Label Lead-in participants only, the requirement to demonstrate transfusion dependence can also be met by a Principal Investigator starting this particular participant on pRBC transfusion during the screening period. No restriction on prior use of recombinant erythropoietins or analogues (erythropoiesis-stimulating agents [ESAs]), except no ESA use within 8 weeks prior to Day 1 registration/randomization. Hemoglobin (Hb) ≤10.0 grams/deciliter (g/dL) during screening Eastern Cooperative Oncology Group (ECOG) of 0-2 at screening Key Exclusion Criteria: Diagnosis of secondary MDS associated with prior chemotherapy, extensive radiation therapy (>25% of bone marrow reserve), and or/other significant chemical or radiation exposure Significant myelofibrosis (>2+ fibrosis) MDS associated with 5q(del) cytogenetic abnormality Screen serum erythropoietin level > 400 milli-international units (mIU)/milliliter (mL) • Clinically significant anemia, as determined by the investigator, due to non-MDS etiologies such as iron deficiency, vitamin B12 or folate deficiency, autoimmune or hereditary hemolysis or anemia or hemorrhage or hereditary anemia such as sickle cell anemia or thalassemia.
Facility Information:
Facility Name
Investigational Site
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Investigational Site
City
Burbank
State/Province
California
ZIP/Postal Code
90212
Country
United States
Facility Name
Investigational Site
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Investigational Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
91326
Country
United States
Facility Name
Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Investigational Site
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Investigational Site
City
Valencia
State/Province
California
ZIP/Postal Code
91355
Country
United States
Facility Name
Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Investigational Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Investigational Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Investigational Site
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Investiational Site
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Investgational site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Investigational Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Investigational Site
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Investigational Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Investigational Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Investigational Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Investigational Site
City
Victoria Park
State/Province
Saint Albans
ZIP/Postal Code
3021
Country
Australia
Facility Name
Investigational Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Investigational Site
City
Wilrijk
State/Province
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Investigational Site
City
Bruxelles
State/Province
Brussels Capital Region
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Investigational Site
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Investigational Site
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Investigational Site
City
Brussels
Country
Belgium
Facility Name
Investigational Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Facility Name
Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada
Facility Name
Investigational Site
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Investigational Site
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
Investigational Site
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38043
Country
France
Facility Name
Investigational Site
City
Paris
Country
France
Facility Name
Investigational Site
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Investigational Site
City
Freiburg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Investigational Site
City
Munchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
Investigational Site
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Investigational Site
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Investigational Site
City
Düsseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632 004
Country
India
Facility Name
Investigational Site
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700014
Country
India
Facility Name
Investigational Site
City
Kfar Saba
State/Province
HaMerkaz
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Investigational Site
City
Zerifin
State/Province
HaMerkaz
ZIP/Postal Code
70300
Country
Israel
Facility Name
Investigational Site
City
Nahariya
State/Province
HaZafon
ZIP/Postal Code
22100
Country
Israel
Facility Name
Investigational Site
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Investigational Site
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Investigational Site
City
Tel Aviv
ZIP/Postal Code
49372
Country
Israel
Facility Name
Investigational site
City
Tel HaShomer
Country
Israel
Facility Name
Investigational Site
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Facility Name
Investigational Site
City
Meldola
State/Province
Ravenna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Investigational Site
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Investigational Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Investigational Site
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Investigational Site
City
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Investigational Site
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Facility Name
Investigational Site
City
Rimini
Country
Italy
Facility Name
Investigational Site
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Investigational Site
City
Terni
ZIP/Postal Code
5100
Country
Italy
Facility Name
Investigational Site
City
Torino
Country
Italy
Facility Name
Investigational Site
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Investigational Site
City
Incheon
State/Province
Incheon Gwang'yeogsi
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Investigational Site
City
Incheon
State/Province
Incheon Gwangyeogsi
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Investigational Site
City
Hwasun
State/Province
Jeonranamdo
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Investigational Site
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Investigational Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Investigational Site
City
Bialystok
ZIP/Postal Code
15-732
Country
Poland
Facility Name
Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Investigational Site
City
Krakow
ZIP/Postal Code
31-513
Country
Poland
Facility Name
Investigational Site
City
Pila
ZIP/Postal Code
64-920
Country
Poland
Facility Name
Investigational Site
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Investigational Site
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Facility Name
Investigational Site
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Investigational Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Investigational Site
City
Saint Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Investigational Site
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigational Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Investigational Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Facility Name
Investigational Site
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Investigational Site
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Investigational Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Investigational Site
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Investigational Site
City
Ankara
ZIP/Postal Code
6500
Country
Turkey
Facility Name
Investigational Site
City
Dikimevi
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Investigational Site
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Investigational Site
City
Izmir
ZIP/Postal Code
59100
Country
Turkey
Facility Name
Investigational Site
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Investigational Site
City
Tekirdag
ZIP/Postal Code
59100
Country
Turkey
Facility Name
Investigational Site
City
Yenisehir
ZIP/Postal Code
33110
Country
Turkey
Facility Name
Investigational Site
City
Boston
State/Province
Lincolnshire
ZIP/Postal Code
PE21 9QS
Country
United Kingdom
Facility Name
Investigational Site
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Investigational Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Investigational Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34724251
Citation
Henry DH, Glaspy J, Harrup R, Mittelman M, Zhou A, Carraway HE, Bradley C, Saha G, Modelska K, Bartels P, Leong R, Yu KP. Roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndrome: Open-label, dose-selection, lead-in stage of a phase 3 study. Am J Hematol. 2022 Feb 1;97(2):174-184. doi: 10.1002/ajh.26397. Epub 2021 Nov 9.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden

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