Study of FG-4592 to Correct Anemia in New Dialysis Patients

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

FibroGen

ClinicalTrials.gov Identifier:

NCT01414075

First received: August 9, 2011

Last updated: March 5, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	August 9, 2011
Last Updated Date	March 5, 2013
Start Date ^ICMJE	July 2011
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 9, 2011)	Maximum change in hemoglobin from baseline [ Time Frame: Weeks 3-13 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01414075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 9, 2011)	Number (%) of subjects with a hemoglobin response [ Time Frame: Weeks 5, 9, 13, 16 ] [ Designated as safety issue: No ] Defined as an increase in hemoglobin by ≥ 1.0 g/dL from baseline. Number (%) of subjects achieving hemoglobin 11.0 - 13.0 g/dL [ Time Frame: Weeks 5-13 ] [ Designated as safety issue: No ] Median time to hemoglobin response [ Time Frame: Week 3-13 ] [ Designated as safety issue: No ] Changes from baseline observations in clinical assessments and clinical laboratory values [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: No ] Number of subjects with adverse events [ Time Frame: Weeks 1-16 ] [ Designated as safety issue: No ] Change from baseline in SF-36 and FACT-An scores [ Time Frame: Weeks 1, 9, 13 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of FG-4592 to Correct Anemia in New Dialysis Patients
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in patients with end-stage renal disease who recently started dialysis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Dialysis Anemia
Intervention ^ICMJE	Drug: FG-4592 Tiered, weight-based dosing with or without oral or intravenous iron supplementation
Study Arm (s)	Experimental: Experimental Drug Intervention: Drug: FG-4592
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	May 2013
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 18 to 80 years Receiving hemodialysis or peritoneal dialysis for end- stage renal disease (ESRD) for 2 weeks to 4 months. Hemoglobin < 10 g/dL Body weight 40 to 140 kg Exclusion Criteria: Previously received erythropoiesis-stimulating agents Received IV iron within 4 weeks prior to randomization Received red blood cell transfusion within 8 weeks prior to randomization Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab) History of chronic liver disease Clinically significant infection New York Heart Association Class III or IV congestive heart failure History of cancer within the past 4 years Chronic inflammatory disease even if it is in remission History of other blood disorders Active hemolysis or diagnosis of hemolytic syndrome Known bone marrow fibrosis Uncontrolled or symptomatic secondary hyperparathyroidism History of alcohol or drug abuse History of allergy or sensitivity to oral or intravenous iron Heart attack, deep vein thrombosis, or pulmonary embolism in the past 3 months Seizure disorder or receiving anti-epilepsy medication Pregnant or breast-feeding females
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Hong Kong, Russian Federation, Singapore

Administrative Information
NCT Number ^ICMJE	NCT01414075
Other Study ID Numbers ^ICMJE	FGCL-4592-053
Has Data Monitoring Committee	Yes
Responsible Party	FibroGen
Study Sponsor ^ICMJE	FibroGen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	FibroGen
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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