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

Purpose

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	Intervention	Phase
CKD Anemia	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:

MedlinePlus related topics: Anemia Kidney Diseases

U.S. FDA Resources

Further study details as provided by FibroGen:

Primary Outcome Measures:

Efficacy of roxadustat (FG-4592) for the treatment of anemia correction and maintenance [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Efficacy of roxadustat (FG-4592) in achieving hemoglobin correction and maintenance (as defined in protocol) in CKD subjects not on dialysis

Secondary Outcome Measures:

Effect of roxadustat (FG-4592) on serum lipid parameters [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
Change in low-density lipoprotein (LDL) cholesterol.
Effect of roxadustat (FG-4592) on patient reported outcomes [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
Evaluate health-related quality of life benefits, as measured by the 36-Item Short Form Health Survey (SF-36)
Evaluate the need for anemia rescue therapy, such as IV Iron, blood transfusion or injectable ESA [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Proportion of patients who received rescue therapy (composite of RBC transfusion, ESA use, and IV iron)
Effect of roxadustat (FG-4592) on blood pressure [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Change in mean arterial pressure and effect on reducing hypertension
Safety of roxadustat (FG-4592) [ Time Frame: Minimum of 52 weeks ] [ Designated as safety issue: Yes ]
Adverse events, serious adverse events, vital signs, electrocardiograms and physical exams


Estimated Enrollment:	600
Study Start Date:	November 2012
Estimated Study Completion Date:	June 2017
Estimated Primary Completion Date:	June 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: Roxadustat; ASP1517; AZD9941

Detailed Description:

There is a screening period of up to 6 weeks, a variable treatment period for individual subjects with a minimum treatment duration of 52 weeks and a maximum treatment duration of time to enroll all subjects plus 52 weeks after the last subject is randomized, and a post-treatment follow-up period of 4 weeks. A total of 600 patients will be randomized in a 2:1 ratio to receive either roxadustat (FG-4592-approximately 400 subjects) or placebo (approximately 200 subjects) in a double-blind manner.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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: NCT01750190

Contacts


Contact: Charles Bradley, PhD	1-415-978-1672	060study@fibrogen.com

Show 166 Study Locations

Sponsors and Collaborators

FibroGen

Astellas Pharma Europe B.V.

AstraZeneca

Investigators


Study Chair:	Peony Yu, MD	FibroGen

More Information


Responsible Party:	FibroGen
ClinicalTrials.gov Identifier:	NCT01750190 History of Changes
Other Study ID Numbers:	FGCL-4592-060
Study First Received:	December 11, 2012
Last Updated:	February 29, 2016
Health Authority:	United States: Food and Drug Administration Malaysia: Ministry of Health Taiwan : Food and Drug Administration Korea: Ministry of Food and Drug Safety Hong Kong: Department of Health Thailand: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Chile: Ministry of Health Mexico: Federal Commission for Protection Against Health Risks Peru: General Directorate of Pharmaceuticals, Devices, and Drugs Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Australia: Department of Health and Ageing Therapeutic Goods Administration Singapore: Health Sciences Authority Philippines : Food and Drug Administration New Zealand: Ministry of Health

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

ClinicalTrials.gov processed this record on September 29, 2016