Trial record 3 of 18 for:    alps

FG-4592 (ASP1517) in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis (ALPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Astellas Pharma Inc
Sponsor:
Collaborator:
FibroGen
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01887600
First received: June 25, 2013
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

This study is conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood. The purpose of the study is to see if FG-4592 (ASP1517) is both effective and safe as a treatment for anemia in patients with chronic kidney disease.


Condition Intervention Phase
Anemia in Chronic Kidney Disease in Non-dialysis Patients
Drug: FG-4592
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Hemoglobin (Hb) response to treatment with FG-4592 treatment with FG-4592 [ Time Frame: Day 1 to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maintenance of Hemoglobin levels [ Time Frame: Week 28 to Week 36 ] [ Designated as safety issue: No ]
  • Change in Low-density Lipoprotein (LDL) cholesterol [ Time Frame: Week 12 to Week 28 ] [ Designated as safety issue: No ]
  • Change in SF-36 Physical Functioning subscore [ Time Frame: Week 12 to Week 28 ] [ Designated as safety issue: No ]
  • Change in SF-36 Vitality subscore [ Time Frame: Week 12 to Week 28 ] [ Designated as safety issue: No ]
  • Blood pressure effect [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
  • Need for rescue therapy as defined by protocol [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
  • Safety of FG-4592 (ASP1517) [ Time Frame: Day 1 to End of Study ] [ Designated as safety issue: No ]
    Evaluate changes in vital signs and laboratory values


Estimated Enrollment: 600
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FG-4592 (ASP1517)_1A
Study drug will be dosed three times weekly (TIW) during correction period then weekly (QW) during the maintenance period. Dose adjustments will be made during the study.
Drug: FG-4592
tablet
Other Names:
  • ASP1517
  • Roxadustat
Experimental: FG-4592 (ASP1517)_2A
Study drug will be dosed three times weekly (TIW) during correction period then twice weekly (BIW) during the maintenance period. Dose adjustments will be made during the study.
Drug: FG-4592
tablet
Other Names:
  • ASP1517
  • Roxadustat
Experimental: FG-4592 (ASP1517)_3A
Study drug will be dosed three times weekly (TIW) during correction period and three times weekly (TIW) during the maintenance period. Dose adjustments will be made during the study.
Drug: FG-4592
tablet
Other Names:
  • ASP1517
  • Roxadustat
Placebo Comparator: Placebo_1P
Placebo will be dosed three times weekly (TIW) during correction period then weekly (QW) during the maintenance period. Dose adjustments will be made during the study.
Drug: Placebo
tablet
Placebo Comparator: Placebo_2P
Placebo will be dosed three times weekly (TIW) during correction period then twice weekly (BIW) during the maintenance period. Dose adjustments will be made during the study.
Drug: Placebo
tablet
Placebo Comparator: Placebo_3P
Placebo will be dosed three times weekly (TIW) during correction period and three times weekly (TIW) during the maintenance period. Dose adjustments will be made during the study.
Drug: Placebo
tablet

Detailed Description:

The study will consist of three study periods as follows:

  • Screening period: up to 6 weeks.
  • Treatment period: 52 to 104 weeks.
  • Post-Treatment Follow-Up period: 4 weeks
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a diagnosis of chronic kidney disease, with Kidney Disease Outcomes Quality Initiative (KDOQI) Stage 3, 4 or 5, not receiving dialysis. The mean of the subject's three most recent Hb values during the Screening period must be ≤10.0 g/dL
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) ≤1.5 x ULN.
  • Body weight is 45.0 kg up to a maximum of 160.0 kg

Exclusion Criteria:

  • Any ESA treatment within 12 weeks prior to randomization.
  • More than one dose of IV iron within 12 weeks prior to randomization.
  • RBC transfusion within 8 weeks prior to randomization.
  • Chronic inflammatory disease that could impact erythropoiesis
  • Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (e.g., pulmonary embolism) within 12 weeks prior to randomization.
  • Two or more blood pressure values of systolic BP≥150 mmHg or diastolic BP≥95mmHg within 2 weeks prior to randomization.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887600

Contacts
Contact: Global Clinical Science +31 (0)71 5455 878 contact@nl.astellas.com

  Show 143 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
FibroGen
Investigators
Study Chair: Medical Monitor Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT01887600     History of Changes
Other Study ID Numbers: 1517-CL-0608, 2012-005180-27
Study First Received: June 25, 2013
Last Updated: March 18, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Italy: The Italian Medicines Agency
Poland: The Central Register of Clinical Trials
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Department of Health
Georgia: Ministry of Health
Ukraine: Ministry of Health

Keywords provided by Astellas Pharma Inc:
anemia
chronic kidney disease (CKD)
non-dialysis
Hemoglobin (Hb)

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 26, 2014