Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008827

Trial Description

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Title

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of FG-4592 in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

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Trial Acronym

Dolomites

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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 chronic kidney
disease. 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 the
study is to see if FG-4592 is effective and safe to treat anemia in patients with chronic
kidney disease. FG-4592 will in this study be compared to darbepoetin alfa, a commercially
available medicine for treatment of anemia (tradename Aranesp®).

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Brief Summary in Scientific Language

This study will consist of three study periods as follows:

- Screening Period: from 2 up to 6 weeks

- Treatment Period: 104 weeks

- Follow-up Period: 4 weeks

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Organizational Data

  •   DRKS00008827
  •   2015/08/12
  •   2013/12/20
  •   no
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Secondary IDs

  •   2013-000951-42 
  •   NCT02021318  (ClinicalTrials.gov)
  •   1517-CL-0610  (Astellas Pharma Europe B.V.)
  •   2013-000951-42 
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Health Condition or Problem studied

  •   Anemia in Chronic Kidney Disease in Non-dialysis Patients
  •   N18 -  Chronic kidney disease
  •   D64 -  Other anaemias
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Interventions/Observational Groups

  •   Drug: FG-4592
  •   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) response to treatment with FG-4592 without the use of rescue therapy; time frame: Day 1 to week 24

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Secondary Outcome

- Hb change from baseline to the average Hb, without having received rescue therapy within 6 weeks prior to and during this 8-week evaluation period; time frame: Baseline and Week 28 to 36
- Change from baseline in Low-Density Lipoprotein (LDL) cholesterol to the average LDL cholesterol of weeks 12 to 28; time frame: Baseline and Weeks 12 to 28
- Mean monthly IV iron use (mg); time frame: Weeks 1 to 36
- Blood pressure effect; time frame: Weeks 1 to 36
- Change from baseline in SF-36 Physical Functioning (PF) sub-score to the average PF sub-score of weeks 12 to 28; time frame: Baseline and Week 12 to 28
- Change from baseline in SF-36 Vitality (VT) sub-score to the average VT sub-score of weeks 12 to 28; time frame: Baseline and Week 12 to 28

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Countries of Recruitment

  •   Austria
  •   Croatia
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Ireland
  •   Israel
  •   Latvia
  •   Netherlands
  •   Portugal
  •   Slovakia
  •   Slovenia
  •   Spain
  •   Sweden
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2014/02/27
  •   570
  •   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

1. Subject has a diagnosis of CKD, with Kidney Disease Outcomes Quality Initiative
(KDOQI) Stage 3, 4 or 5, not on dialysis

2. The mean of the subject's three most recent Hb values during the Screening Period,
must be ≤10.0 g/dL.

3. Subject is deemed suitable by the investigator for treatment with erythropoiesis
stimulating agents (ESA) using the criteria specified in the KDIGO 2012
recommendation.

4. 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.

5. Subject's body weight is 45.0 kg to a maximum of 160.0 kg.

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Exclusion Criteria

1. Any ESA treatment within 12 weeks prior to randomization.

2. Any dose of IV iron within 6 weeks prior to randomization.

3. Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization.

4. Chronic inflammatory disease that could impact erythropoiesis

5. Myocardial infarction, acute coronary syndrome, stroke, seizure, or a
thrombotic/thromboembolic event & (e.g., deep vein thrombosis or pulmonary embolism)
within 12 weeks prior to randomization.

6. One or more contraindications for treatment with darbepoetin alfa:

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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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    • Astellas Pharma Europe B.V.
    • Medical Monitor 
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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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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.