A Study of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not Receiving Dialysis

Study Description

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Brief Summary:

The purpose of this study is to determine whether FG-4592 is safe and effective in the treatment of anemia in chronic kidney disease patients who are not on dialysis.

Condition or disease	Intervention/treatment	Phase
CKD Anemia	Drug: FG-4592; Drug: Placebo	Phase 3

Detailed Description:

There is a screening period of up to 6 weeks, a variable treatment period for individual subjects. In order to complete the treatment period simultaneously for all study subjects, the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration of up to 3 years after the last subject is randomized, and a post-treatment follow-up period of 4 weeks. Subjects were randomized in a 2:1 ratio to receive either roxadustat (FG-4592) or placebo in a double-blind manner.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	922 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	November 2012
Estimated Primary Completion Date :	March 2018
Estimated Study Completion Date :	March 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: FG-4592 (Double-blind, Three times a week); Weight-based starting doses of 70mg or 100mg; dose adjustments to hemoglobin levels are allowed during the study.	Drug: FG-4592; Oral; Other Name: Roxadustat; ASP1517; AZD9941
Placebo Comparator: Placebo (Double-blind, Three times a week); Weight-based starting doses of 70mg or 100mg; dose adjustments to hemoglobin levels are allowed during the study.	Drug: Placebo; Oral

Outcome Measures

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Primary Outcome Measures :

1. Efficacy of roxadustat (FG-4592) for the treatment of anemia correction and maintenance [ Time Frame: 52 weeks ]
   Efficacy of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance (as defined in protocol) in CKD subjects not on dialysis

Secondary Outcome Measures :

1. Effect of roxadustat (FG-4592) on serum lipid parameters [ Time Frame: 28 weeks ]
   Change in low-density lipoprotein (LDL) cholesterol.
2. Effect of roxadustat (FG-4592) on patient reported outcomes [ Time Frame: 28 weeks ]
   Evaluate health-related quality of life benefits, as measured by the 36-Item Short Form Health Survey (SF-36)
3. Evaluate the need for anemia rescue therapy, such as IV Iron, blood transfusion or injectable ESA [ Time Frame: 52 weeks ]
   Proportion of patients who received rescue therapy (composite of RBC transfusion, ESA use, and IV iron)
4. Effect of roxadustat (FG-4592) on blood pressure [ Time Frame: 52 weeks ]
   Change in mean arterial pressure and effect on reducing hypertension
5. Safety of roxadustat (FG-4592) [ Time Frame: Minimum of 52 weeks ]
   Adverse events, serious adverse events, vital signs, electrocardiograms and physical exams

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Chronic kidney disease, Stage 3, 4, or 5, not receiving dialysis
• Anemia qualified by measurements of hemoglobin values during screening
• Additional blood work must be in a safe range for study entry
• Body weight 45 to 160 kg
• Willingness to use contraception if of child-bearing potential

Exclusion Criteria:

• Treatment with an erythropoiesis-stimulating agent (ESA) within 12 weeks prior to study participation
• More than one dose of intravenous iron within 12 weeks prior to study participation
• Blood transfusion within 8 weeks prior to study participation
• Active infection
• Chronic liver disease
• Severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot
• Uncontrolled blood pressure within 2 weeks prior to study participation
• Renal cell carcinoma
• History of malignancy, including multiple myeloma or other myelodysplastic syndrome
• Chronic inflammatory disease that could impact red blood cell production
• Any prior organ transplant, or a scheduled organ transplantation
• Anticipated elective surgery that is expected to lead to significant blood loss, or anticipated elective heart procedure
• Gastrointestinal bleeding
• Any prior treatment with FG-4592 or a HIF-PHI
• Recent use of an investigational drug or treatment, or participation in an investigational study

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 145 Study Locations

Sponsors and Collaborators

FibroGen

Astellas Pharma Europe B.V.

AstraZeneca

Investigators

Study Chair:	Peony Yu, MD	FibroGen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	FibroGen
ClinicalTrials.gov Identifier:	NCT01750190 History of Changes
Other Study ID Numbers:	FGCL-4592-060
First Posted:	December 17, 2012
Last Update Posted:	November 8, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by FibroGen:

anemia; chronic kidney disease (CKD); non-dialysis; Hemoglobin (Hb); End-Stage Renal Disease	erythropoeitin; ASP1517; erythropoeisis stimulating-agent; AZD9941

Additional relevant MeSH terms:

Anemia; Kidney Diseases; Renal Insufficiency, Chronic	Hematologic Diseases; Urologic Diseases; Renal Insufficiency