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 December 2012 by FibroGen
Sponsor:
FibroGen
Collaborator:
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01750190
First received: December 11, 2012
Last updated: December 14, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to evaluate the safety and efficacy of FG-4592 in the treatment of anemia of Chronic Kidney Disease (CKD).
| Condition | Intervention | Phase |
|---|---|---|
|
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:
Further study details as provided by FibroGen:
Primary Outcome Measures:
- Efficacy of FG-4592 - anemia correction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]Efficacy of FG-4592 in achieving hemoglobin response (as defined in protocol) in CKD subjects not receiving dialysis
Secondary Outcome Measures:
- Efficacy of FG-4592 - Maintenance of hemoglobin levels [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Evaluate the need for anemia rescue therapy, such as blood transfusion, intravenous Iron, or injectable erythrocyte stimulating therapies [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Safety of FG-4592 [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]Evaluate changes in vital signs and laboratory values
- FG-4592 Tolerability [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]Evaluate Adverse Events (AE) and Serious Adverse Events (SAE)
| Estimated Enrollment: | 450 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: FG-4592
Study drug will be dosed three times weekly (TIW), twice weekly (BIW) or weekly (QW) for FG-4592. Dose adjustments will be made during study.
|
Drug: FG-4592 |
|
Placebo Comparator: Placebo
Study drug will be dosed TIW, BIW, or QW for Placebo. Dose adjustments will be made during study.
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01750190
Contacts
| Contact: Clinical Trial Coordinator | 415-978-1672 | 4592studyteam@fibrogen.com |
Locations
| United States, California | |
| Investigational Site | Recruiting |
| Chula Vista, California, United States, 91910 | |
| Investigational Site | Recruiting |
| Northridge, California, United States, 91325 | |
| Investigational Site | Recruiting |
| Riverside, California, United States, 92505 | |
| Investigational Site | Recruiting |
| Yuba City, California, United States, 95991 | |
| Australia | |
| Investigational Site | Not yet recruiting |
| Sydney, Australia | |
| Hong Kong | |
| Investigational Site | Not yet recruiting |
| Hong Kong, Hong Kong | |
| Korea, Republic of | |
| Investigational Site | Not yet recruiting |
| Seoul, Korea, Republic of | |
Sponsors and Collaborators
FibroGen
Astellas Pharma Europe B.V.
More Information
No publications provided
| 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: | December 14, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by FibroGen:
|
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 June 18, 2013