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

Sponsor

FibroGen (Industry)

Overall Status

Completed

CT.gov ID

NCT01599507

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia in Chronic Kidney Disease	Drug: FG-4592 Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 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
Placebo Comparator: Placebo	Drug: Placebo TIW dosing, capsule

Arm

Intervention/Treatment

Experimental: FG-4592

Active Drug

Drug: FG-4592

TIW dosing, capsule

Placebo Comparator: Placebo

Drug: Placebo

TIW dosing, capsule

Outcome Measures

Primary Outcome Measures

Maximum change in hemoglobin by Week 9 from baseline [Week 9]

Secondary Outcome Measures

Proportion of subjects achieving a target Hb level ≥11 g/dL by Weeks 5,6,7,8 and 9. [Week 9]
Proportion of subjects with a Hb increase from baseline ≥1.0 g/dL. [Week 9]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 to 75 years
Subject has voluntarily signed and dated an informed consent form
Chronic Kidney Disease, not receiving dialysis
Hemoglobin (Hb) values in 4 screening visits and the mean Hb must be <10g/dL
Aminotransferase levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) and total bilirubin must be ≤ upper limit of normal (ULN) during the screening period
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
Total bilirubin values must be ≤ULN during screening period
Serum folate and vitamin B12 levels above the lower limit of normal (LLN)
Body weight: 40 to 100 kg (dry weight) inclusive
Body mass index (BMI): 16 to 38 kg/m2 inclusive

Exclusion Criteria:

Received any erythropoiesis-stimulating agent (ESA) other than epoetin alfa within 12 weeks prior to Day 1
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,
Positive for any of the following: human immunodeficiency virus (HIV); hepatitis B surface antigen (HBsAg); anti-hepatitis C virus antibody (anti-HCV Ab)
History of chronic liver disease
New York Heart Association Class III or IV congestive heart failure
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
Active or chronic gastrointestinal bleeding, or a known coagulation disorder
Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)
Hematological disorders, including myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
History of hemosiderosis, hemochromatosis, polycystic kidney disease, or anephric
Active hemolysis or diagnosis of hemolytic syndrome
Known bone marrow fibrosis
Uncontrolled or symptomatic secondary hyperparathyroidism (PTH>600ng/L)
Any prior organ transplantation
Drug-treated gastroparesis, short-bowel syndrome, or any other gastrointestinal condition that may lead to reduced absorption of study drug
Serum albumin <3 g/dL
History of alcohol or drug abuse; or a positive drug screen for a substance that has not been prescribed for the subject
Prior treatment with FG-4592
Use of an investigational medication or treatment, or carryover effect of an investigational treatment expected, during the screening visit, treatment and follow-up period.
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	Country
1	Peking Union Medical College Hospital	Beijing	China
2	Peking University First Hospital	Beijing	China
3	Sichuan Provincial People's Hospital	Chengdu	China
4	West China Hospital	Chengdu	China
5	First affiliated hospital of Dalian medical university	DaLian	China
6	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	China
7	Zhejiang University No 1. Hospital	Hangzhou	China
8	Chang Zheng Hospital	Shanghai	China
9	Huashan Hospital	Shanghai	China
10	Renji Hospital	Shanghai	China
11	RuiJin Hospital	Shanghai	China
12	XinHua Hospital	Shanghai	China
13	Shenzhen People's Hospital	Shenzhen	China