Study of FG-4592 in Subjects With Chronic Kidney Disease in China

Anemia in Chronic Kidney Disease Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose Ranging Safety and Efficacy Study of FG 4592 in Non-dialysis Chronic Kidney Disease (CKD) Subjects With Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599507
• Other study ID #: FGCL-4592-047
• Status: Completed
• Phase: Phase 2
• First received: May 11, 2012
• Last updated: February 27, 2014
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2014
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to evaluate efficacy and safety of FG-4592 in the correction of anemia in non-dialysis chronic kidney disease patients.

Description:

Dose ranging study with two consecutive dose escalation cohorts. The study objective is to demonstrate that FG-4592 is effective in the correction of anemia in chronic kidney disease patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 75 years

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

3. Chronic Kidney Disease, not receiving dialysis

4. Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be <10g/dL

5. Aminotransferase levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) and total bilirubin must be = upper limit of normal (ULN) during the screening period

6. Serum alkaline phosphatase (ALP) =2x ULN during screening period. Subjects with serum ALP values between 1 x and 2 x ULN may be included only if bone-specific ALP (BSAP) is also elevated > ULN

7. Total bilirubin values must be =ULN during screening period

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

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

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

Exclusion Criteria:

1. Received any erythropoiesis-stimulating agent (ESA) other than epoetin alfa within 12 weeks prior to Day 1

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. Serum albumin <3 g/dL

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

18. Prior treatment with FG-4592

19. Use of an investigational medication or treatment, or carryover effect of an investigational treatment expected, during the screening visit, treatment and follow-up period.

20. 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia in Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• FG-4592
TIW dosing, capsule
• Placebo
TIW dosing, capsule

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Sichuan Provincial People's Hospital	Chengdu
China	West China Hospital	Chengdu
China	First affiliated hospital of Dalian medical university	DaLian
China	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou
China	Zhejiang University No 1. Hospital	Hangzhou
China	Chang Zheng Hospital	Shanghai
China	Huashan Hospital	Shanghai
China	Renji Hospital	Shanghai
China	RuiJin Hospital	Shanghai
China	XinHua Hospital	Shanghai
China	Shenzhen People's Hospital	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum change in hemoglobin by Week 9 from baseline		Week 9
Secondary	Proportion of subjects achieving a target Hb level =11 g/dL by Weeks 5,6,7,8 and 9.		Week 9
Secondary	Proportion of subjects with a Hb increase from baseline =1.0 g/dL.		Week 9