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Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants (ASPEN)

Primary Purpose

Anemia Associated With End Stage Renal Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Roxadustat
Sponsored by
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia Associated With End Stage Renal Disease

Eligibility Criteria

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

Key Inclusion Criteria:

  • Receiving chronic dialysis for end stage renal disease (ESRD)
  • Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunnelled catheter
  • Screening Hb criteria: Participants converting from an ESA: between 9.0 to 12.0 grams (g)/deciliter (dL); Participants initiating anemia treatment: < 10.0 g/dL
  • Ferritin ≥ 50 nanograms (ng)/mililiter (mL), Transferrin saturation (TSAT) ≥ 10% at screening
  • Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤ 3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤ 1.5 x ULN at screening and prior to initiating roxadustat treatment.
  • Body weight between 45.0 to 160.0 kg

Key Exclusion Criteria:

  • Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
  • Known history of myelodysplastic syndrome or multiple myeloma
  • Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
  • Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
  • Active or chronic gastrointestinal bleeding
  • Treated with iron-chelating agents within 4 weeks prior to enrollment
  • History of New York Heart Association (NYHA) Class III or IV congestive heart failure
  • History of myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment
  • Uncontrolled hypertension, in the opinion of the Investigator
  • Participant has a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma (Principal Investigator's discretion)
  • History of malignancy, except for cancers determined to be cured or in remission for ≥ 2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps

Sites / Locations

  • Alaska
  • Investigator Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigator Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigator Site
  • Investigational Site
  • Investigational Site
  • Investigator Site
  • Investigational Site
  • Investigational Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigational Site
  • Investigational Site
  • Investigator Sites
  • Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Roxadustat

Arm Description

Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant require roxadustat <60 milligrams (mg)/week to maintain hemoglobin (Hb) levels, the dose frequency will be reduced in a stepwise manner, for example, to twice weekly (BIW), and then once weekly (QW). For participants converted from an ESA, the initial roxadustat dose will be based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for methoxy polyethylene glycol-epoetin beta [Mircera®]). For participants with <6 weeks of prior ESA use, the initial roxadustat dose will be based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations will be made every 4 weeks and doses will be titrated based on Hb level and rate of Hb change. The prescribed dose will not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever is lower.

Outcomes

Primary Outcome Measures

Percentage of Participants With Mean Hb Value ≥10 g/dL
Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.
Mean Hb Change From Baseline to Average Hb From Weeks 16-24
Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2020
Last Updated
July 1, 2022
Sponsor
FibroGen
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04484857
Brief Title
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
Acronym
ASPEN
Official Title
Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From an Erythropoiesis Stimulating Agent (ESA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
July 9, 2021 (Actual)
Study Completion Date
September 17, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia Associated With End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
283 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roxadustat
Arm Type
Experimental
Arm Description
Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant require roxadustat <60 milligrams (mg)/week to maintain hemoglobin (Hb) levels, the dose frequency will be reduced in a stepwise manner, for example, to twice weekly (BIW), and then once weekly (QW). For participants converted from an ESA, the initial roxadustat dose will be based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for methoxy polyethylene glycol-epoetin beta [Mircera®]). For participants with <6 weeks of prior ESA use, the initial roxadustat dose will be based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations will be made every 4 weeks and doses will be titrated based on Hb level and rate of Hb change. The prescribed dose will not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever is lower.
Intervention Type
Drug
Intervention Name(s)
Roxadustat
Intervention Description
Roxadustat will be administered per dose and schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Percentage of Participants With Mean Hb Value ≥10 g/dL
Description
Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.
Time Frame
Week 16 through Week 24
Title
Mean Hb Change From Baseline to Average Hb From Weeks 16-24
Description
Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model.
Time Frame
Baseline, Weeks 16-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Receiving chronic dialysis for end stage renal disease (ESRD) Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunnelled catheter Screening Hb criteria: Participants converting from an ESA: between 9.0 to 12.0 grams (g)/deciliter (dL); Participants initiating anemia treatment: < 10.0 g/dL Ferritin ≥ 50 nanograms (ng)/mililiter (mL), Transferrin saturation (TSAT) ≥ 10% at screening Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤ 3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤ 1.5 x ULN at screening and prior to initiating roxadustat treatment. Body weight between 45.0 to 160.0 kg Key Exclusion Criteria: Red blood cell (RBC) transfusion within 4 weeks prior to enrollment Known history of myelodysplastic syndrome or multiple myeloma Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD) Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia Active or chronic gastrointestinal bleeding Treated with iron-chelating agents within 4 weeks prior to enrollment History of New York Heart Association (NYHA) Class III or IV congestive heart failure History of myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment Uncontrolled hypertension, in the opinion of the Investigator Participant has a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma (Principal Investigator's discretion) History of malignancy, except for cancers determined to be cured or in remission for ≥ 2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Eisner
Organizational Affiliation
FibroGen
Official's Role
Study Chair
Facility Information:
Facility Name
Alaska
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99515
Country
United States
Facility Name
Investigator Site
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
Investigational Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Investigational Site
City
Victorville
State/Province
California
ZIP/Postal Code
92394
Country
United States
Facility Name
Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Investigational Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States
Facility Name
Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Investigator Site
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30720
Country
United States
Facility Name
Investigational Site
City
Statesboro
State/Province
Georgia
ZIP/Postal Code
30458
Country
United States
Facility Name
Investigational Site
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89178
Country
United States
Facility Name
Investigator Site
City
Gallup
State/Province
New Mexico
ZIP/Postal Code
87301
Country
United States
Facility Name
Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigator Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79924
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Investigator Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78202
Country
United States
Facility Name
Investigator Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78211
Country
United States
Facility Name
Investigator Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78221
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78251
Country
United States
Facility Name
Investigator Sites
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78521
Country
United States
Facility Name
Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants

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