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

NCT04059913 | Completed Phase 4

• 1 other identifier: FGCL-4592-818
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 25

Brief Summary

This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period. There are 3 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)

Conditions

CKD Anemia in Dialysis Participants

Keywords

Anemia; Chronic Kidney Disease Dialysis; hemoglobin; End stage renal disease

Outcome Measures

Primary Outcomes (3)

• Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks

  Weeks 1 to 20

• Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits

  Weeks 17 to 21

• Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits

  Weeks 33 to 37

Secondary Outcomes (3)

• Part 1: Mean Change in Hb Level From Baseline to Average Over Weeks 17 to 21 Visits

  Baseline, Weeks 17 to 21

• Part 1 (ESA-Naïve): Percentage of Participants With Mean Hb (Averaged Weeks 17 to 21 Visits) ≥100 g/L

  Weeks 17 to 21

• Part 2: Percentage of Participants With Mean Hb (Averaged Weeks 33 to 37 Visits) ≥100 g/L

  Weeks 33 to 37

Study Arms (7)

Part 1: ESA-Naïve Participants - Low Weight Based Dosing

EXPERIMENTAL

ESA-naïve participants will receive roxadustat 70 mg TIW for body weight 45 to \<60 kg or 100 mg TIW for body weight ≥60 kg.

Drug: Roxadustat

Part 1: ESA-Naïve Participants - Standard Weight Based Dosing

EXPERIMENTAL

ESA naïve participants will receive roxadustat 100 mg TIW for body weight 45 to \<60 kg or 120 mg TIW for body weight ≥60 kg.

Drug: Roxadustat

Part 1: ESA-Treated Participants - Low Weight Based Dosing

EXPERIMENTAL

ESA-treated participants will receive roxadustat 70 mg TIW for body weight 45 to \<60 kg or 100 mg TIW for body weight ≥60 kg.

Drug: Roxadustat

Part 1: ESA-Treated Participants - Standard Weight Based Dosing

EXPERIMENTAL

ESA treated participants will receive roxadustat 100 mg TIW for body weight 45 to \<60 kg or 120 mg TIW for body weight ≥60 kg.

Drug: Roxadustat

Part 2: Roxadustat QW

EXPERIMENTAL

Participants will receive roxadustat once a week (QW). Roxadustat dose will be 2-dose step increase from originally planned week 21 TIW per dose amount.

Drug: Roxadustat

Part 2: Roxadustat BIW

EXPERIMENTAL

Participants will receive roxadustat twice a week (BIW). Roxadustat dose will be 1-dose step increase from originally planned week 21 TIW per dose amount.

Drug: Roxadustat

Part 2: Roxadustat TIW

EXPERIMENTAL

Participants will receive roxadustat TIW. Roxadustat dose will continue per dose adjustment guideline.

Drug: Roxadustat

Interventions

Roxadustat DRUG

Roxadustat will be dosed orally per dose and schedule specified in the arm description.

Also known as: FG-4592

Part 1: ESA-Naïve Participants - Low Weight Based Dosing; Part 1: ESA-Naïve Participants - Standard Weight Based Dosing; Part 1: ESA-Treated Participants - Low Weight Based Dosing; Part 1: ESA-Treated Participants - Standard Weight Based Dosing; Part 2: Roxadustat BIW; Part 2: Roxadustat QW; Part 2: Roxadustat TIW

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)

You may not qualify if:

• Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
• Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (for example, deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1.
• History of malignancy, myelodysplastic syndrome, and multiple myeloma.
• Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis \[SLE\], rheumatoid arthritis, celiac disease).
• Clinically significant gastrointestinal bleeding.
• Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.

Sponsors & Collaborators

• Kyntra Bio: lead

Study Sites (25)

Investigational Site

Hefei, Anhui, 230601, China

Location

Investigational Site

Lanzhou, Gansu, 730030, China

Location

Investigational Site

Guangzhou, Guangdong, 510515, China

Location

Investigational Site

Shenzhen, Guangdong, 518020, China

Location

Investigational Site

Nanning, Guangxi, 530021, China

Location

Investigational Site

Zhengzhou, Henan, 450052, China

Location

Investigational Site

Wuhan, Hubei, 430060, China

Location

Investigational Site

Changsha, Hunan, 410008, China

Location

Investigational Site

Baotou, Inner Mongolia, 014010, China

Location

Investigational Site

Nanjing, Jiangsu, 210009, China

Location

Investigational Site

Nanchang, Jiangxi, 330006, China

Location

Investigational Site

Changchun, Jilin, 130021, China

Location

Investigational Site

Shenyang, Liaoning, 110004, China

Location

Investigational Site

Shenyang, Liaoning, 110122, China

Location

Investigational Site

Taiyuan, Shanxi, 030001, China

Location

Investigational Site

Xi’an, Shanxi, 710004, China

Location

Investigational Site

Xi’an, Shanxi, 710061, China

Location

Investigational Site

Chengdu, Sichuan, 610041, China

Location

Investigational Site

Chengdu, Sichuan, 610072, China

Location

Investigational Site

Hangzhou, Zhejiang, 310003, China

Location

Investigational Site

Beijing, 100044, China

Location

Investigational Site

Beijing, 100191, China

Location

Investigational Site

Beijing, 100730, China

Location

Investigational Site

Shanghai, 200025, China

Location

Investigational Site

Tianjin, 300052, China

Location

Related Publications (1)

• 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.

  PMID: 36005278 DERIVED

MeSH Terms

Conditions

Anemia; Kidney Failure, Chronic

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 16, 2019
• Study Start: June 11, 2019
• Primary Completion: November 19, 2021
• Study Completion: December 17, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (25)