Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease

NCT01630889 | Completed Phase 2 Results DMC

• 1 other identifier: FGCL-4592-059
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 7

Brief Summary

The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study.

Conditions

Chronic Kidney Disease; End Stage Renal Disease; Anemia

Keywords

Kidney; ESRD; End Stage Renal Disease; Anemia; Oral anemia treatment; Hemoglobin levels; Hemodialysis; CKD; Chronic Kidney Disease; Peritoneal; HD; PD; Hb; Erythropoietin; Blood count

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hb Over Time

  Hb baseline was defined as the mean of the central laboratory Hb value from the baseline visit at Day 1 (prior to receiving the first dose of study drug in this study), plus any other central lab Hb values within 15 days prior to Day 1 regardless of fasting. The specific duration over which the participants were assessed was identified as "over time" for the endpoint in the study protocol. Therefore, to be consistent with the endpoint in the study protocol, an individual timepoint was not identified for this primary outcome measure.

  Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 252, 264, 288, 312, 336, 360, and 384

Secondary Outcomes (5)

• Number of Participants With Hb ≥10 g/dL

  Baseline up to Week 384

• Number of Participants Receiving Rescue Therapy (Composite of Blood Transfusions, Intravenous [IV] Iron, Erythropoiesis-Stimulating Agent [ESA])

  Baseline up to Week 385

• Mean Weekly Dose of Study Drug Over Time

  Baseline up to Week 384

• Number of Participants With Dose Adjustments up to Week 52

  Baseline up to Week 52

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

  Baseline up to Week 385

Study Arms (1)

Roxadustat

EXPERIMENTAL

Participants previously randomized to roxadustat will receive roxadustat at the same dose and frequency assigned at the last dose in the previous FibroGen study. Dose adjustments will be implemented (up to a maximum roxadustat dose of 3.0 mg/kg or 400 mg, whichever is lower) every 4 weeks to maintain Hb levels at 10.0-12 grams (g)/deciliter (dL). However, if a participant, at any dose, experiences an event of excessive hematopoiesis then the participant's dose will be immediately reduced, or an event of rapidly declining Hb then the participant's dose will be immediately increased. Participants will be permitted to receive roxadustat for up to 8 years.

Drug: Roxadustat

Interventions

Roxadustat DRUG

Oral capsule

Also known as: FG-4592

Roxadustat

Eligibility Criteria

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

You may qualify if:

• Minimum age 18 years
• Completed the Treatment Period of an ongoing roxadustat FibroGen-sponsored anemia study in the United States.

You may not qualify if:

• Participants assigned to epoetin alfa in a previous ongoing roxadustat anemia study
• Pregnant or breastfeeding females
• Females of childbearing potential, unless using adequate contraception; male participants with sexual partners of childbearing potential who are not on birth control unless the male participant agrees to use adequate contraception
• Participants who received roxadustat in a previous study that did not demonstrate adequate hemoglobin response per the investigator's clinical judgment
• Any medical condition that in the opinion of the investigator may pose a safety risk to a participant in this study or which may interfere with study participation

Sponsors & Collaborators

• Kyntra Bio: lead
• AstraZeneca: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (7)

APEX Research

Riverside, California, 92505, United States

Location

Unknown Facility

Greenbelt, Maryland, 20770, United States

Location

Mountain Kidney & HTN Associates, PA

Asheville, North Carolina, 28801, United States

Location

Arlington Nephrology

Arlington, Texas, 76015, United States

Location

Consolidated Medical Plaza

Caguas, 00725, Puerto Rico

Location

CAIMED School of Medicine

Ponce, 00716, Puerto Rico

Location

Unknown Facility

San Juan, 00918, Puerto Rico

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia

Interventions

roxadustat

Condition Hierarchy (Ancestors)

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; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

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

059study@fibrogen.com

415-978-1441

Study Officials

• Peony Yu

  Kyntra Bio

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 28, 2012
• Study Start: May 18, 2012
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: October 1, 2021
• Results First Posted: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

PR (3); US (4)