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Trial record 1 of 1 for:    NCT02273726
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Evaluation of Efficacy and Safety of Roxadustat in the Treatment of Anemia in Stable Dialysis Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02273726
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : November 18, 2019
Sponsor:
Collaborators:
Astellas Pharma Europe B.V.
AstraZeneca
Information provided by (Responsible Party):
FibroGen

Tracking Information
First Submitted Date  ICMJE October 22, 2014
First Posted Date  ICMJE October 24, 2014
Last Update Posted Date November 18, 2019
Study Start Date  ICMJE December 2014
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
The primary efficacy endpoint for US is defined as each subject's Hb change from baseline to the average level during the evaluation period, defined as Weeks 28 to 52. [ Time Frame: Baseline to Week 52 ]
Hb values under the influence of rescue therapy will not be censored for the primary analysis. The analysis will be based on the ITT Population. The primary efficacy endpoint for Ex-US is defined as the Hb change from baseline to the average Hb of Weeks 28 to 36, without having received rescue therapy within 6 weeks prior to and during this 8-week evaluation period and will be based on the PPS population.
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
US (FDA) submission: Hemoglobin (Hb) change from baseline to the average Hb level during the evaluation period defined as Week 28 until Week 52. Ex-US submission: Hb change from baseline to the average Hb level of Weeks 28 to 36. [ Time Frame: Baseline to Week 52 ]
The primary efficacy endpoint for US is defined as each subject's Hb change from baseline to the average level during the evaluation period, defined as Weeks 28 to 52. Hb values under the influence of rescue therapy will not be censored for the primary analysis. The analysis will be based on the ITT Population. The primary efficacy endpoint for Ex-US is defined as the Hb change from baseline to the average Hb of Weeks 28 to 36, without having received rescue therapy within 6 weeks prior to and during this 8-week evaluation period and will be based on the PPS population.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • US (FDA) submission: The proportion of subjects with a mean Hb level ≥10.0 g/dL during the evaluation period [ Time Frame: Day 1 to Week 52 ]
  • Ex-US submissions: Hemoglobin response (mean Hb 10.0 to 12.0 g/dL), during Weeks 28 to 36 without having received rescue therapy [ Time Frame: Day 1 to Week 52 ]
  • Average monthly IV Iron use per subject [ Time Frame: Weeks 1 to 36 ]
  • Change from baseline in low density lipoprotein (LDL) [ Time Frame: Weeks 12 to 28 ]
  • Change from baseline in SF-36 Physical Functioning (PF) sub-score [ Time Frame: Weeks 20 to 28 ]
  • Change from baseline in SF-36 Vitality (VT) sub-score [ Time Frame: Weeks 20 to 28 ]
  • Effect on predialysis blood pressure (BP) [ Time Frame: Weeks 1 to 36 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Efficacy and Safety of Roxadustat in the Treatment of Anemia in Stable Dialysis Subjects
Official Title  ICMJE A Phase 3, Open-Label, Randomized, Active-Controlled Study of the Efficacy and Safety of Roxadustat (FG-4592) in the Maintenance Treatment of Anemia in Subjects With End Stage Renal Disease (ESRD) on Stable Dialysis
Brief Summary

The purpose of this study is to determine whether roxadustat is effective and safe compared to epoetin alfa in the maintenance treatment of anemia in stable hemodialysis and peritoneal dialysis subjects when converted from their existing stable erythropoiesis stimulating agent treatment.

Amendment 1: The primary purpose of this amendment is to evaluate safety and efficacy of roxadustat compared to epoetin-alfa in newly initiated (incident) dialysis subjects who have been on ESA (≥ 4 weeks) for treatment of anemia prior to screening

Detailed Description

This study will consist of three study periods as follows:

  1. Screening Period of up to 6 weeks (8 weeks if on Mircera)
  2. Treatment Period: a minimum of 52 weeks, a maximum of up to 3 years.
  3. A Follow-up period of 4 weeks.

A total of up to 820 patients will be randomized in a 1:1 ratio to receive either roxadustat or Epoetin alfa (Active Control) in an open-label manner.

Under Amendment 1, approximately 150 incident dialysis subjects will be randomized to either roxadustat or epoetin alfa (active control) in a 1:1 ratio

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CKD Anemia in Stable Dialysis Patients
Intervention  ICMJE
  • Drug: Epoetin Alfa
    Epoetin alfa will be dosed intravenously three times a week.
  • Drug: FG-4592
    Roxadustat will be dosed orally three times a week.
    Other Name: Roxadustat
Study Arms  ICMJE
  • Experimental: Roxadustat (FG-4592)
    Roxadustat will be dosed orally three times a week.
    Intervention: Drug: FG-4592
  • Active Comparator: Epoetin Alfa
    Epoetin alfa will be dosed intravenously three times a week.
    Intervention: Drug: Epoetin Alfa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2019)
741
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2014)
1200
Actual Study Completion Date  ICMJE September 19, 2018
Actual Primary Completion Date September 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject age ≥ 18 years
  • Subject receiving adequate dialysis using the same modality of dialysis for end-stage renal disease for ≥ 3 months prior to and during screening.

Amendment 1 Only: Incident dialysis subjects receiving dialysis for native kidney ESRD for ≥ 2 weeks but ≤ 4 months at the time of randomization

  • Subject is receiving IV or SC ESA for ≥ 8 weeks prior to screening and on a stable ESA (≤30% change) dose during 4 weeks ( 8 weeks if on Mircera) prior to randomization.

Amendment 1 Only: Incident dialysis subjects must be on ESA for ≥ 4 weeks prior to screening

  • Mean of subject's 3 most recent Hb values must be ≥ 9.0 g/dL and ≤ 12.0 g/dL; with an absolute difference of ≤ 1.3 g/dL between the highest and the lowest value.

Amendment 1 Only: For Incident dialysis subjects, mean of the three most recent central lab Hb values during the Screening Period must be ≥ 8.5 g/dL and ≤12.0 g/dL

  • Subject has a ferritin level of ≥ 100 ng/mL at screening
  • Subject has a transferrin saturation (TSAT) level be ≥ 20% at screening
  • Subject has a serum folate level ≥ lower limit of normal (LLN), Vitamin B12 level ≥ LLN
  • Subject's ALT and AST are ≤ 3x the upper limit of normal (ULN), and TBL is ≤ 1.5x ULN at screening
  • Subject's body weight 45 kg to 160 kg.

Exclusion Criteria:

  • Subject received an RBC transfusion within 8 weeks prior to randomization
  • Subject has known history of myelodysplastic syndrome or multiple myeloma
  • Subject has known inherited disease such as thalassemia or sickle cell anemia or other known causes for anemia other than chronic kidney disease.
  • Subject has known hemosiderosis, hemochromatosis, coagulation disorder,or hypercoagulable condition
  • Subject has known chronic inflammatory disease that could cause anemia
  • Subject has anticipated surgery that is expected to cause blood loss
  • Subject has known gastrointestinal bleeding
  • Subject has history of chronic liver disease (eg,chronic infectious hepatitis,chronic auto-immune liver disease,cirrhosis, or fibrosis of the liver)
  • Subject has congestive heart failure (NYHA Class III or IV)
  • Subject has had a heart attack, stroke, seizure, or a thrombotic/thromboembolic event (eg, DVT or pulmonary embolism) within 12 weeks prior to participating in the study
  • Subject has uncontrolled high blood pressure within 2 weeks prior to participating in the study
  • Subject has a history of malignancy, except for the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps.)
  • Subject is positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen, or anti-hepatitis C virus antibody
  • Subject has had any prior organ transplant (that has not been explanted)
  • Subject has any of the following known untreated conditions; proliferative diabetic retinopathy,diabetic macular edema,macular degeneration or retinal vein occlusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02273726
Other Study ID Numbers  ICMJE FGCL-4592-064
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FibroGen
Study Sponsor  ICMJE FibroGen
Collaborators  ICMJE
  • Astellas Pharma Europe B.V.
  • AstraZeneca
Investigators  ICMJE
Study Director: Pamela Bartels FibroGen
PRS Account FibroGen
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP