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A Study of FG-4592 for the Treatment of Anemia in Chronic Kidney Disease Patients Not Receiving Dialysis
This study is currently recruiting participants.
Verified February 2017 by FibroGen
Sponsor:
FibroGen
Collaborators:
Astellas Pharma Europe B.V.
AstraZeneca
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01750190
First received: December 11, 2012
Last updated: February 24, 2017
Last verified: February 2017
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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 Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
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 ]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 ]Change in low-density lipoprotein (LDL) cholesterol.
- 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)
- 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)
- Effect of roxadustat (FG-4592) on blood pressure [ Time Frame: 52 weeks ]Change in mean arterial pressure and effect on reducing hypertension
- Safety of roxadustat (FG-4592) [ Time Frame: Minimum of 52 weeks ]Adverse events, serious adverse events, vital signs, electrocardiograms and physical exams
| Estimated Enrollment: | 900 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | March 2018 (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) |
| 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
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
Show 179 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750190
Contacts
| Contact: Charles Bradley, PhD | 1-415-978-1672 | 060study@fibrogen.com |
Show 179 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 24, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | Yes |
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 June 26, 2017