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

NCT ID: NCT01599507

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-01-31

Brief 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.

Detailed 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.

Conditions

Anemia in Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FG-4592

Active Drug

Group Type: EXPERIMENTAL

FG-4592

Intervention Type: DRUG

TIW dosing, capsule

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

TIW dosing, capsule

Interventions

FG-4592

TIW dosing, capsule

Intervention Type: DRUG

Placebo

TIW dosing, capsule

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FibroGen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , China

Countries

China

References

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

Reference Type: DERIVED

PMID: 36005278 (View on PubMed)

Other Identifiers

FGCL-4592-047

Identifier Type: -

Identifier Source: org_study_id