Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008806

Trial Description

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Title

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Subjects on Stable Dialysis

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Trial Acronym

Pyrenees

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is conducted to explore a new therapy for anemia in patients with end stage renal
disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin.
Hemoglobin (which contains iron) is important for the transport of oxygen in your blood. The
purpose of this study is to evaluate if roxadustat is effective and safe in the maintenance
treatment of anemia in ESRD patients on stable dialysis. Roxadustat will be compared to
epoetin alfa and darbepoetin alfa, commercially available medicines for treatment of anemia.

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Brief Summary in Scientific Language

This study will consist of three study periods as follows:

- Screening Period: up to 6 weeks

- Treatment Period: 104 weeks

- Follow-up Period: 4 weeks

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Organizational Data

  •   DRKS00008806
  •   2015/07/08
  •   2014/10/28
  •   no
  •   [---]*
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Secondary IDs

  •   2013-001497-16 
  •   NCT02278341  (ClinicalTrials.gov)
  •   1517-CL-0613  (Astellas Pharma Europe B.V.)
  •   2013-001497-16 
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Health Condition or Problem studied

  •   Anemia
  •   End Stage Renal Disease (ESRD)
  •   D64 -  Other anaemias
  •   N18 -  Chronic kidney disease
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Interventions/Observational Groups

  •   Drug: roxadustat
  •   Drug: epoetin alfa
  •   Drug: darbepoetin alfa
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Hemoglobin (Hb) change from baseline to the average Hb of weeks 28 to 36 without having received rescue therapy; time frame: Baseline and Weeks 28 to 36

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Secondary Outcome

- Hb response without having received rescue therapy; time frame: Weeks 28 to 36
- Change from baseline in Low Density Lipoprotein (LDL) cholesterol to the average LDL cholesterol; time frame: Baseline and Weeks 12 to 28
- Mean monthly intravenous (IV) iron use (mg); time frame: Day 1 to Week 36
- Blood pressure effect: Change from baseline in mean arterial pressure (MAP) to the average MAP value; time frame: Baseline and Weeks 20 to 28
- Blood pressure effect: Time to an increase in blood pressure; time frame: Weeks 1 to 26
- Change from baseline in SF-36 Physical Functioning (PF) sub-score to the average PF sub-score; time frame: Baseline and Weeks 12 to 28
- Change from baseline in SF-36 Vitality (VT) sub-score to the average VT sub-score; time frame: Baseline and Weeks 12 to 28

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Countries of Recruitment

  •   Belgium
  •   Bulgaria
  •   Croatia
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Poland
  •   Portugal
  •   Serbia
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/11/30
  •   750
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Main Inclusion:

- Subject is on stable hemodialysis (HD), hemodiafiltration (HDF) or peritoneal
dialysis (PD) treatment with the same mode of dialysis for ≥4 months prior to
randomization.

- Subject is on IV or SC epoetin or IV or SC darbepoetin alfa treatment for ≥8 weeks
prior to randomization with stable weekly doses (during 4 weeks prior to
randomization).

- Mean of the subject's three most recent Hb values, as measured by central laboratory,
during the Screening Period.

- Subject'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.

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Exclusion Criteria

Main Exclusion:

- Subject has received a red blood cell (RBC) transfusion within 8 weeks prior to
randomization.

- Subject has a known hereditary hematologic disease such as thalassemia or sickle cell
anemia, pure red cell aplasia, or other known causes for anemia other than Chronic
Kidney Disease (CKD).

- Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or
a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary embolism)
within 12 weeks prior to randomization.

- Subject has had uncontrolled hypertension, in the opinion of the investigator, within
2 weeks prior to randomization.

- 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 has had any prior organ transplant (that has not been explanted), or subject
is scheduled for organ transplantation.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Astellas Pharma Europe B.V.
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    • FibroGen
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    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • Astellas Pharma Europe B.V.
    • Study Physician 
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    •   [---]*
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    • Global Clinical Science 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2015/06/17
* This entry means the parameter is not applicable or has not been set.