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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Roxadustat

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Kidney, ESRD, End Stage Renal Disease, Anemia, Oral anemia treatment, Hemoglobin levels, Hemodialysis, CKD, Chronic Kidney Disease, Peritoneal, HD, PD, Hb, Erythropoietin, Blood count

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria

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

Sites / Locations

APEX Research
Mountain Kidney & HTN Associates, PA
Arlington Nephrology
Consolidated Medical Plaza
CAIMED School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Roxadustat

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Hb ≥10 g/dL

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.

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

Mean Weekly Dose of Study Drug Over Time

Weekly dose amount was the actual total dose amounts within a week, windowed by 7-day period from Day 1. The mean weekly dose is presented for selected time periods based on timepoints reported in Outcome Measures 1 and 2.

Number of Participants With Dose Adjustments up to Week 52

Dose adjustments include dose increases, dose interruptions, and dose reductions.

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

An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Full Information

NCT ID

NCT01630889

First Posted

June 8, 2012

Last Updated

September 1, 2021

Sponsor

FibroGen

Collaborators

AstraZeneca, Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT01630889

Brief Title

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

Official Title

Open-Label Extension Study to Evaluate the Efficacy and Safety of FG-4592 for the Long-Term Maintenance Treatment of Anemia in Dialysis and Non-Dialysis Patients With Chronic Kidney Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

May 18, 2012 (Actual)

Primary Completion Date

December 12, 2019 (Actual)

Study Completion Date

December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FibroGen

Collaborators

AstraZeneca, Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This is an open-label, long-term maintenance study of roxadustat anemia therapy in participants with dialysis and non-dialysis CKD who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study. Participants assigned to roxadustat in the previous study will continue to receive the same roxadustat dose and dosing frequency, unless a dose adjustment is required.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Roxadustat

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Roxadustat

Other Intervention Name(s)

FG-4592

Intervention Description

Oral capsule

Primary Outcome Measure Information:

Title

Change From Baseline in Hb Over Time

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Number of Participants With Hb ≥10 g/dL

Description

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.

Time Frame

Baseline up to Week 384

Title

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

Time Frame

Baseline up to Week 385

Title

Mean Weekly Dose of Study Drug Over Time

Description

Weekly dose amount was the actual total dose amounts within a week, windowed by 7-day period from Day 1. The mean weekly dose is presented for selected time periods based on timepoints reported in Outcome Measures 1 and 2.

Time Frame

Baseline up to Week 384

Title

Number of Participants With Dose Adjustments up to Week 52

Description

Dose adjustments include dose increases, dose interruptions, and dose reductions.

Time Frame

Baseline up to Week 52

Title

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

Description

An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Time Frame

Baseline up to Week 385

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peony Yu

Organizational Affiliation

FibroGen

Official's Role

Study Director

Facility Information:

Facility Name

APEX Research

City

Riverside

State/Province

California

ZIP/Postal Code

92505

Country

United States

City

Greenbelt

State/Province

Maryland

ZIP/Postal Code

20770

Country

United States

Facility Name

Mountain Kidney & HTN Associates, PA

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Arlington Nephrology

City

Arlington

State/Province

Texas

ZIP/Postal Code

76015

Country

United States

Facility Name

Consolidated Medical Plaza

City

Caguas

ZIP/Postal Code

00725

Country

Puerto Rico

Facility Name

CAIMED School of Medicine

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Yes

Chronic Kidney Disease, End Stage Renal Disease, Anemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial