Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Subjects With Chronic Kidney Disease

A Prospective, Randomized, Open-Label, Multi-Center Study to Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Subjects With Chronic Kidney Disease

Sponsors

Lead Sponsor: FibroGen

Source FibroGen
Brief Summary

This is a randomized, open-label, multi-center study in dialysis CKD subjects to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.

There are three study periods:

- Screening Period (up to 4 weeks)

- Treatment Period (36 weeks)

Part 1: Correction/Conversion Period (weeks 1-20)

Part 2: Hemoglobin (Hb) Maintenance Period (weeks 21-36)

- Follow-up Period (4 weeks)

Detailed Description

Approximately 102 ESA-naïve subjects and 204 ESA-treated subjects will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one of two starting doses as below:

- Low weight-based dosing: 70 mg TIW for body weight < 60 kg or 100 mg TIW for body weight ≥ 60 kg

- Standard weight-based dosing: 100 mg TIW for body weight < 60 kg or 120 mg TIW for body weight ≥ 60 kg

After 20 weeks of treatment, all eligible subjects whose last two Hb levels ≥ 10.5 g/dL AND change in Hb over most recent 4 weeks is > - 10 g/dL will switch to receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing regimens.

At end of Week 36, all subjects will discontinue roxadustat and enter a 4-week Follow-up Period.

Overall Status Recruiting
Start Date June 11, 2019
Completion Date November 2021
Primary Completion Date October 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Part 1 (Weeks 1-20): to descriptively compare efficacy of 2 starting doses Weeks 1-21
Part 2 (Weeks 21-36): to compare efficacy of roxadustat at different frequencies Weeks 33-37
Secondary Outcome
Measure Time Frame
Mean change in Hb level from baseline to average over Weeks 17- 21 visits Weeks 17-21
ESA-naïve: the proportion of subjects with mean Hb (averaged Week 17 to 21 visits) ≥ 10 g/dL Weeks 17-21
Proportion of subjects with mean Hb (averaged Weeks 33 to 37 visits) ≥ 10 g/dL Weeks 33-37
Enrollment 306
Condition
Intervention

Intervention Type: Drug

Intervention Name: FG-4592

Description: Roxadustat will be dosed orally

Eligibility

Criteria:

Inclusion Criteria:

1. Chronic kidney disease with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)

Exclusion Criteria:

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

2. Cardiovascular risks such as: myocardial infarction, stroke, heart failure or a thromboembolic event (e.g., deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1.

3. History of malignancy, myelodysplastic syndrome, and multiple myeloma.

4. Disease conditions that could impact red blood cell production.

5. Recent blood loss (i.e clinically significant gastrointestinal bleeding).

6. Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Contact

Last Name: Chunrong Wang

Phone: +86 -21- 68810689

Email: [email protected]

Location
Facility: Status:
Investigational Site | Hefei, Anhui, 230601, China Recruiting
Investigational Site | Lanzhou, Gansu, 730030, China Recruiting
Investigational Site | Guangzhou, Guangdong, 510515, China Recruiting
Investigational Site | Shenzhen, Guangdong, 518020, China Recruiting
Investigational Site | Nanning, Guangxi Province, 530021, China Recruiting
Investigational Site | Zhengzhou, Henan, 450052, China Recruiting
Investigational Site | Wuhan, Hubei, 430060, China Recruiting
Investigational Site | Changsha, Hunan, 410008, China Recruiting
Investigational Site | Baotou, Inner Mongolia Autonomous Region, 014010, China Recruiting
Investigational Site | Nanjing, Jiangsu, 210009, China Recruiting
Investigational Site | Nanchang, Jiangxi, 330006, China Recruiting
Investigational Site | Chang chun, Jilin, 130021, China Recruiting
Investigational Site | Shenyang, Liaoning, 110004, China Recruiting
Investigational Site | Shenyang, Liaoning, 110122, China Recruiting
Investigational Site | Taiyuan, Shanxi, 030001, China Recruiting
Investigational Site | Xi'an, Shanxi, 710004, China Recruiting
Investigational Site | Xi'an, Shanxi, 710061, China Recruiting
Investigational Site | Chengdu, Sichuan, 610041, China Recruiting
Investigational Site | Chengdu, Sichuan, 610072, China Recruiting
Investigational Site | Hangzhou, Zhejiang, 310003, China Recruiting
Investigational Site | Beijing, 100044, China Recruiting
Investigational Site | Beijing, 100191, China Recruiting
Investigational Site | Beijing, 100730, China Recruiting
Investigational Site | Shanghai, 200025, China Recruiting
Investigational Site | Tianjin, 300052, China Recruiting
Location Countries

China

Verification Date

August 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Part 1 (2 arms) and Part 2

Type: Other

Description: The purpose of Part 1 is to evaluate difference between low and standard weight-based doses and Part 2 is to evaluate the difference among dosing frequencies

Label: Part 1

Type: Other

Description: Part 1: Arm Type: Other Arm Title: Low weight-based dosing Arm 1: Low weight-based dosing Arm Description: Subjects in this arm will receive roxadustat 70 mg three times a week (TIW) for body weight < 60 kg or 100 mg TIW for body weight ≥ 60 kg Arm Type: Other Arm Title: Standard weight-based dosing Arm 2: Standard weight-based dosing Arm Description: Subjects in this arm will receive roxadustat 100 mg TIW for body weight < 60 kg or 120 mg TIW for body weight ≥ 60 kg

Label: Part 2

Type: Other

Description: Part 2: Arm Type: Other Arm Title: Roxadustat Arm Description: Subjects in this arm will receive roxadustat at different dose frequencies

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov