Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants

NCT04410198 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FGCL-4592-097
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis participants converted from ESA therapy or who are ESA-naïve.

Conditions

Anemia Associated With End Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Mean Hb Value ≥10 g/dL

  Percentage of participants with mean Hb value ≥10 g/dL, averaged from Week 16 through Week 24 has been reported. 95% confidence interval (CI) was calculated based on the normal approximation to the binomial distribution.

  Week 16 through Week 24

• Mean Hb Change From Baseline to Average Hb From Weeks 16-24

  Baseline Hb was defined as the mean of available central laboratory Hb values prior to first dose of study medication including the predose Hb value collected on Day 1. Missing data was imputed using Monte Carlo Markov Chain (MCMC) imputation model.

  Baseline, Weeks 16-24

Study Arms (1)

Roxadustat

EXPERIMENTAL

Participants will receive roxadustat as an oral tablet, 3 times per week (TIW) for up to a maximum of 24 weeks. If a participant requires roxadustat \<60 milligrams (mg)/week to maintain Hb levels, the dose frequency will be reduced in a stepwise manner, for example, to BIW, and then QW. For participants converted from CERA, the initial roxadustat dose will be based on the average prescribed CERA dose in the last 8 weeks prior to conversion. For participants with \<6 weeks of prior CERA use, the initial roxadustat dose will be based on a 2-tiered, weight-based dosing scheme. Dose adjustment evaluations will be made every 4 weeks and doses will be titrated based on Hb level and rate of Hb change. The prescribed dose will not exceed the maximum allowable dose of 3.0 mg/kilogram (kg)/dose or 400 mg per dose, whichever is lower.

Drug: Roxadustat

Interventions

Roxadustat DRUG

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

Roxadustat

Eligibility Criteria

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

You may qualify if:

• Receiving chronic dialysis for end stage renal disease (ESRD)
• Vascular access must be a functioning native arteriovenous fistula or graft with adequate flow in the opinion of the investigator, or permanent tunneled catheter
• Screening hemoglobin criteria (based on central lab value; measured within 10 days prior to initiating Roxadustat treatment: Participants converting from CERA: screening heamoglobin was between 9.0 to 12.0 g/dL; Participants initiating anemia treatment: \<10.0 g/dL
• Ferritin ≥ 50 nanograms (ng)/milliliter (mL), Transferrin saturation (TSAT) ≥ 10% at screening
• Participant's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN at screening and prior to initiating roxadustat treatment.
• Body weight between 45.0 to 160.0 kg

You may not qualify if:

• Red blood cell (RBC) transfusion within 4 weeks prior to enrollment
• Known history of myelodysplastic syndrome or multiple myeloma
• Known hereditary hematologic disease or other known causes for anemia other than chronic kidney disease (CKD)
• Known chronic inflammatory disease that is determined by the investigator to be the primary cause of anemia
• Active or chronic gastrointestinal bleeding
• Treated with iron-chelating agents within 4 weeks prior to enrollment
• History of New York Heart Association (NYHA) Class III or IV congestive heart failure
• History of myocardial infarction (MI), acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (excluding vascular dialysis access stenosis/thrombosis) within 12 weeks prior to enrollment
• Uncontrolled hypertension, in the opinion of the Investigator
• Diagnosis or suspicion of renal cell carcinoma as shown on renal imaging performed within 24 weeks prior to enrollment
• History of malignancy, except for cancers determined to be cured or in remission for ≥2 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps

Sponsors & Collaborators

• Kyntra Bio: lead
• AstraZeneca: collaborator

Study Sites (9)

Investigational Site

Englewood, Colorado, 80110, United States

Location

Investigational Site

Caldwell, Idaho, 83642, United States

Location

Investigational Site

Baton Rouge, Louisiana, 70808, United States

Location

Investigational Site

Kalamazoo, Michigan, 49009, United States

Location

Investigational Site

Tupelo, Mississippi, 38801, United States

Location

Investigational Site

Saint Ann, Missouri, 63074, United States

Location

Investigational Site

Las Vegas, Nevada, 89106, United States

Location

Investigational Site

Sugar Land, Texas, 77479, United States

Location

Investigational Site

St. George, Utah, 84790, United States

Location

MeSH Terms

Interventions

roxadustat

Results Point of Contact

• Title: Clinical Trial Information Desk
• Organization: FibroGen, Inc.

FG4592-097Study@fibrogen.com

415-978-1441

Study Officials

• Mark Eisner

  Kyntra Bio

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: May 26, 2020
• Primary Completion: June 30, 2021
• Study Completion: October 11, 2021
• Last Updated: September 13, 2022
• Results First Posted: September 13, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)