Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants

NCT04484857 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FGCL-4592-096
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 26

Brief Summary

The purpose of this study is to assess the safety and effectiveness of roxadustat dosing regimens among hemodialysis participants converted from erythropoiesis stimulating agent (ESA) therapy or who are ESA-naïve.

Conditions

Anemia Associated With End Stage Renal Disease

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. 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. 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 require roxadustat \<60 milligrams (mg)/week to maintain hemoglobin (Hb) levels, the dose frequency will be reduced in a stepwise manner, for example, to twice weekly (BIW), and then once weekly (QW). For participants converted from an ESA, the initial roxadustat dose will be based on the average prescribed ESA dose in the last 4 weeks (for epoetin alfa and darbepoetin alfa) or 8 weeks (for methoxy polyethylene glycol-epoetin beta \[Mircera®\]). For participants with \<6 weeks of prior ESA 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 tunnelled catheter
• Screening Hb criteria: Participants converting from an ESA: between 9.0 to 12.0 grams (g)/deciliter (dL); Participants initiating anemia treatment: \< 10.0 g/dL
• Ferritin ≥ 50 nanograms (ng)/mililiter (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, 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
• Participant has a diagnosis or suspicion (for example, complex kidney cyst of Bosniak Category II or higher) of renal cell carcinoma (Principal Investigator's discretion)
• 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 (26)

Alaska

Anchorage, Alaska, 99515, United States

Location

Investigator Site

Pine Bluff, Arkansas, 71603, United States

Location

Investigational Site

Cerritos, California, 90703, United States

Location

Investigational Site

Victorville, California, 92394, United States

Location

Investigational Site

Denver, Colorado, 80230, United States

Location

Investigational Site

Hartford, Connecticut, 06112, United States

Location

Investigational Site

Coral Gables, Florida, 33134, United States

Location

Investigational Site

Hollywood, Florida, 33024, United States

Location

Investigator Site

Dalton, Georgia, 30720, United States

Location

Investigational Site

Statesboro, Georgia, 30458, United States

Location

Investigational Site

Roseville, Michigan, 48066, United States

Location

Investigational Site

Kansas City, Missouri, 64111, United States

Location

Investigational Site

Las Vegas, Nevada, 89178, United States

Location

Investigator Site

Gallup, New Mexico, 87301, United States

Location

Investigational Site

The Bronx, New York, 10461, United States

Location

Investigational Site

Austin, Texas, 78229, United States

Location

Investigator Site

Dallas, Texas, 75237, United States

Location

Investigational Site

El Paso, Texas, 79924, United States

Location

Investigational Site

Houston, Texas, 77004, United States

Location

Investigator Site

San Antonio, Texas, 78202, United States

Location

Investigator Site

San Antonio, Texas, 78211, United States

Location

Investigator Site

San Antonio, Texas, 78221, United States

Location

Investigational Site

San Antonio, Texas, 78229, United States

Location

Investigational Site

San Antonio, Texas, 78251, United States

Location

Investigator Sites

San Antonio, Texas, 78521, United States

Location

Investigational Site

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Interventions

roxadustat

Results Point of Contact

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

FG4592-096Study@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: July 21, 2020
• First Posted: July 24, 2020
• Study Start: July 22, 2020
• Primary Completion: July 9, 2021
• Study Completion: September 17, 2021
• Last Updated: July 26, 2022
• Results First Posted: July 26, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)