Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China

• Sponsor: FibroGen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01596855
• Collaborator: Ruijin Hospital (Other), RenJi Hospital (Other), Chang Zheng Hospital (Other), Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other), Peking University First Hospital (Other), First Affiliated Hospital, Sun Yat-Sen University (Other), First Affiliated Hospital of Zhejiang University (Other), Peking Union Medical College Hospital (Other), Shenzhen People's Hospital (Other)
• Enrollment: 96
• Locations: 9
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on maintenance hemodialysis and receiving epoetin alfa.

Condition or Disease	Intervention/Treatment	Phase
Anemia in End Stage Renal Disease	Drug: FG-4592; Drug: Epoetin Alfa	Phase 2

Detailed Description

Dose ranging study with three consecutive dose escalation cohorts. The study objectives are to demonstrate that FG-4592 is effective in maintaining hemoglobin (Hb) levels when converting from epoetin alfa and to establish optimum starting doses and dose adjustment regimens for Hb maintenance.

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized, Open-Label Active-Comparator (Epoetin Alfa) Dose-Ranging Safety and Exploratory Efficacy Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis (HD)
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FG-4592 Active Drug	Drug: FG-4592; TIW dosing, capsule
Active Comparator: Epoetin alfa Standard of care	Drug: Epoetin Alfa; TIW

Outcome Measures

Primary Outcome Measures

1. Hemoglobin maintenance using FG-4592 dosing regimen in ESRD subjects. Number of subjects who hemoglobin levels are maintained at no lower than 0.5 g/dL below their mean baseline value during weeks 6 and 7. [Week 7]

Secondary Outcome Measures

1. Number (%) of subjects whose hemoglobin levels are between 9.0 and 13.0 g/dL at Weeks 3, 4, 5, 6 and 7. [Week 7]

2. Number (%) of subjects whose hemoglobin levels at Weeks 3, 4, 5, 6 and 7 are greater than or equal to their baseline level. [Week 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject has voluntarily signed and dated an informed consent form

2. Age 18 to 75 years

3. End-stage renal disease (ESRD) and receiving maintenance hemodialysis TIW for ≥4 months prior to Day 1

4. Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be between 9.0 and 12.0 g/dL (inclusive), and the difference between them must be ≤1.5 g/dL.

5. Stable doses of IV or Subcutaneous injection of epoetin alfa, defined as follows:

• Epoetin alfa dose range for 6 weeks prior to Day -7:

3000 to 20,000 IU/week

• Stable doses of epoetin alfa (i.e., the maximum epoetin alfa dose does not exceed 130% of the lowest dose of epoetin alfa taken in this period)

1. Complete Blood Count (CBC), Hematology, liver function blood tests within acceptable limits

2. Serum folate and vitamin B12 levels above the lower limit of normal (LLN)

3. Body weight: 40 to 100 kg (dry weight) inclusive

4. Body mass index (BMI): 16 to 38 kg/m2 inclusive

5. HD subjects: dialysis vascular access via native arteriovenous fistula or synthetic graft (not via catheter)

Exclusion Criteria:

1. Anticipated change in hemodialysis prescription or access during the screening or dosing period of the study

2. Any clinically significant infection or evidence of an underlying infection such as a white blood cell count (WBC) > ULN during screening on two separate occasions,

3. Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)

4. History of chronic liver disease

5. New York Heart Association Class III or IV congestive heart failure

6. Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission

7. Active or chronic gastrointestinal bleeding, or a known coagulation disorder

8. Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)

9. Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia

10. History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric

11. Active hemolysis or diagnosis of hemolytic syndrome

12. Known bone marrow fibrosis

13. Uncontrolled or symptomatic secondary hyperparathyroidism (PTH>600ng/L)

14. Any prior organ transplantation

15. Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug

16. History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject

17. Prior treatment with FG-4592

18. Use of traditional Chinese medicines (TCM) during the screening visit to Day 1 or plans to use TCM during the study unless approved in advance by the Medical Monitor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing		China
2	Peking University First Hospital	Beijing		China
3	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou		China
4	Zhejiang University No 1. Hospital	Hangzhou		China
5	Chang Zheng Hospital	Shanghai		China
6	Renji Hospital	Shanghai		China
7	RuiJin Hospital	Shanghai		China
8	XinHua Hospital	Shanghai		China
9	ShenZhen People's Hospital	Shenzhen		China

Sponsors and Collaborators

• FibroGen
• Ruijin Hospital
• RenJi Hospital
• Chang Zheng Hospital
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Peking University First Hospital
• First Affiliated Hospital, Sun Yat-Sen University
• First Affiliated Hospital of Zhejiang University
• Peking Union Medical College Hospital
• Shenzhen People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: FibroGen
• ClinicalTrials.gov Identifier: NCT01596855
• Other Study ID Numbers: FGCL-4592-048
• First Posted: May 11, 2012
• Last Update Posted: Feb 4, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by FibroGen: Anemia; Renal
• Additional relevant MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Epoetin Alfa

Study Results

No Results Posted as of Feb 4, 2013