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Chronic Kidney DiseasePhase 2NCT01244763

Study of Roxadustat in Non-Dialysis Chronic Kidney Disease Participants With Anemia

A Phase 2 study testing Roxadustat in people with Chronic Kidney Disease and Anemia, run by Kyntra Bio at 38 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Kidney Disease, Anemia
What is being tested?
Roxadustat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
38 sitesin 2 countries
Study dates
29 Oct 2010to 13 Jun 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75 years
  • Chronic kidney disease, not receiving dialysis
  • Body weight 45 to 140 kg

Who cannot join

  • Any clinically significant infection or evidence of an underlying infection
  • Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
  • History of chronic liver disease
  • New York Heart Association Class III or IV congestive heart failure
  • Myocardial infarction or acute coronary syndrome within 12 weeks prior to randomization
  • History of malignancy
Show all 16Show fewer
  • Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
  • History of myelodysplastic syndrome, multiple myeloma, or pure red cell aplasia
  • History of hemosiderosis, hemochromatosis or polycystic kidney disease
  • Active hemolysis or diagnosis of hemolytic syndrome
  • Uncontrolled or symptomatic secondary hyperparathyroidism
  • Seizure disorder or receiving anti-epilepsy medication
  • Known bone marrow fibrosis
  • Any prior or scheduled organ transplant
  • Prior treatment with roxadustat or any hypoxia-inducible factor prolyl hydroxylase inhibitor
  • History of alcohol or drug abuse

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

United States35 sites

  • Study site

    Arlington, Texas

  • Study site

    Asheville, North Carolina

  • Study site

    Augusta, Georgia

  • Study site

    Azusa, California

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Bethesda, Maryland

  • Study site

    Canton, Ohio

  • Study site

    Chula Vista, California

  • Study site

    Detroit, Michigan

  • Study site

    Downey, California

  • Study site

    Fairfax, Virginia

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Houston, Texas

  • Study site

    Knoxville, Tennessee

  • Study site

    Lauderdale Lakes, Florida

  • Study site

    Lincoln, Nebraska

  • Study site

    Meridian, Idaho

  • Study site

    Mineola, New York

  • Study site

    Mobile, Alabama

  • Study site

    Mount Laurel, New Jersey

  • Study site

    New York, New York

  • Study site

    Northridge, California

  • Study site

    Orangeburg, South Carolina

  • Study site

    Paramount, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pine Bluff, Arkansas

  • Study site

    Raleigh, North Carolina

  • Study site

    Riverside, California

  • Study site

    San Antonio, Texas

  • Study site

    Shreveport, Louisiana

  • Study site

    Tampa, Florida

  • Study site

    Whittier, California

  • Study site

    Wichita, Kansas

  • Study site

    Yuba City, California

Other trials in United States

Puerto Rico3 sites

  • Study site

    Caguas

  • Study site

    Ponce

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Randomized, Open-Label, Dose Titration, Efficacy and Safety Study of FG-4592 (Roxadustat) in Non-Dialysis Chronic Kidney Disease Patients With Anemia

The primary purpose of this study is to evaluate efficacy and safety of roxadustat in the correction of anemia in participants with non-dialysis chronic kidney disease.

Being tested
Roxadustat
Keywords
Kidney, Chronic Kidney Disease, CKD, Renal, Anemia, Oral anemia treatment, Hemoglobin levels, Erythropoietin, Blood count, Predialysis, Pre-dialysis, Hb, Non-dialysis
Medical subject headings
Renal Insufficiency, Chronic, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RoxadustatDrug

    Also called FG-4592

    Oral capsule

Study groups in NCT01244763
Study groupRoleWhat they receive
Cohort A: Roxadustat Tiered, Weight Based Dosing TIWExperimentalParticipants will receive roxadustat capsules, administered orally 3 times weekly (TIW) for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kilograms (kg)], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants will receive 60, 100, and 140 milligrams [mg] roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL.
Receives: Drug: Roxadustat
Cohort B: Roxadustat Tiered, Weight Based Dosing TIW then BIWExperimentalParticipants will receive roxadustat capsules orally for 16 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants will receive 60, 100, and 140 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to 2 times a week (BIW) at the time of the initial Hb response.
Receives: Drug: Roxadustat
Cohort C: Roxadustat at 50 mg TIWExperimentalParticipants will receive roxadustat capsules at 50 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
Receives: Drug: Roxadustat
Cohort D: Roxadustat at 100 mg TIWExperimentalParticipants will receive roxadustat capsules at 100 mg, administered orally TIW for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.2 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 10.5-12 g/dL.
Receives: Drug: Roxadustat
Cohort E: Roxadustat Tiered, Weight Based Dosing BIW then QWExperimentalParticipants will receive roxadustat capsules for 24 weeks. Initial roxadustat dose will be based on a tiered, weight-based dosing scheme (low-weight [45 to 60 kg], medium-weight [>60 to 90 kg], and heavy-weight [>90 to 140 kg] participants will receive 70, 100, and 150 mg roxadustat, respectively). Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from BIW to 1 time a week (QW) at the time of the initial Hb response.
Receives: Drug: Roxadustat
Cohort F: Roxadustat at 70 mg BIW then QWExperimentalParticipants will receive roxadustat capsules at 70 mg for 24 weeks. Dose adjustments will be implemented (up to a maximum roxadustat dose of 2.5 mg/kg per dose) every 4 weeks starting Week 5 to maintain Hb levels at 11-13 g/dL. Participants will have a dose frequency reduction from TIW to BIW at the time of the initial Hb response. Then after >8 weeks of stable Hb, dose frequency will be reduced from BIW to QW.
Receives: Drug: Roxadustat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number (%) of Participants With an Hb Response by Week 17

    An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.

    Measured: Up to Week 17

Secondary outcomes (19)

  1. Number (%) of Participants With an Hb Response by Weeks 5, 9, 13, 17, 21, and 25

    An Hb response was defined as a Hb level of ≥11 g/dL and an increase from BL ≥1 g/dL.

    Measured: Up to Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

  2. Change From Baseline in Hb at Weeks 5, 9, 13, 17, 21, and 25

    Baseline is defined as the mean of the last 3 available values predose.

    Measured: Baseline, Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

  3. Number (%) of Participants With Mean Hb Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28

    Participants can have a Hb value reported for more than 1 of the categories (11-12, 11-13, and 10.5-13 g/dL) during the week intervals since these categories are not mutually exclusive.

    Measured: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

  4. Number (%) of Participants With 2 Consecutive Hb Values Between 11-12, 11-13, and 10.5-13 g/dL During Weeks 5-8, 9-12, 13-16, 9-16, 17-20, 17-24, 21-24, and 25-28

    Measured: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

  5. Number (%) of Participants Who Achieve Maximum Hb Between 11-12, 11-13, and 10.5-13 g/dL by Weeks 5, 9, 13, 17, 21, and 25

    Participants can have a Hb value for the same category (11-12, 11-13, or 10.5-13 g/dL) reported for multiple weeks.

    Measured: Weeks 5, 9, 13, and 17 (all cohorts) and Weeks 21 and 25 (24-week treatment cohorts only)

  6. Number (%) of Participants With Maximum Hb <11, >12, >13, and >14 g/dL During Weeks 5-8, 9-12, 9-16, 13-16, 17-20, 17-24, 21-24, and 25-28

    Measured: Weeks 5-8, 9-12, 9-16, 13-16, and 17-20 (all cohorts) and Weeks 17-24, 21-24, and 25-28 (24-week treatment cohorts only)

  7. Median Time to Hb Response: Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL

    Median time to response was estimated using Kaplan Meier method, Cohort A and B censored at Week 17, Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.

    Measured: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)

  8. Median Initial Hb Responsive Time: Time to Initial Hb Increase ≥1.0 g/dL From Baseline

    Median time to response was estimated using Kaplan Meier method; Cohort A and B censored at Week 17 and Cohort C, D, E, and F censored at Week 25. The median number of days presented was calculated from Baseline to the day the Hb response was achieved.

    Measured: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C, D, E, and F)

  9. Median Initial Hb Responsive Dose: Dose at Which Initial Hb Increases to ≥1.0 g/dL From Baseline

    Measured: Up to Week 17 (Cohorts A and B) and up to Week 25 (Cohorts C-F)

  10. Change in Hb After Reaching a Hb Response of ≥11.0 g/dL and an Increase in Hb by ≥1.0 g/dL by Week

    Measured: Cohorts A and B: Weekly through Week 16 (end of treatment), Week 18 (2 weeks posttreatment), and Week 20 (4 weeks posttreatment); Cohorts C-F: Weekly through Week 24 (end of treatment), Week 26 (2 weeks posttreatment), and Week 28 (4 weeks posttreatment)

  11. Mean Hb Values From Participants Who Reached Hb >11.0 g/dL in the Hb 11-12, 11-13, and 10.5-13 g/dL Categories

    Measured: Cohorts A and B: Weekly through Week 16 (end of treatment [EoT]) and Week 20 (Follow up [4 weeks posttreatment]); Cohorts C-F: Weekly through Week 24 (EoT) and Week 28 (Follow up [4 weeks posttreatment])

  12. Mean of Weekly Hb Values <10.5, >13, and >14 g/dL During Weeks 13-17 and 18-25

    The mean percentage of the scheduled weekly Hb values that were <10.5, >13, and >14 g/dL during Weeks 13-17 and 18-25 is presented.

    Measured: Weeks 13-17 (all cohorts) and 18-25 (24-week treatment cohorts only)

  13. Number (%) of Participants Requiring Rescue Therapy

    Rescue treatment included recombinant erythropoiesis-stimulating agent (ESA), red blood cell transfusion (in the absence of a known bleeding episode or surgical blood loss), or intravenous (IV) Iron

    Measured: Baseline up to Week 28 (end of study)

  14. Number (%) of Participants Requiring Therapeutic Phlebotomy

    Measured: Baseline up to Week 28 (end of study)

  15. Number (%) of Participants Withdrawn From the Study Due to Inadequate Efficacy

    Measured: Baseline up to Week 28 (end of study)

  16. Number (%) of Participants With Dose Changes During Weeks 1-4, 5-12, 13-16, and 17-24

    Dose changes include dose reductions, dose increases, and dose holds.

    Measured: Weeks 1-4, 5-12, and 13-16 (all cohorts) and Weeks 17-24 (24-week treatment cohorts only)

  17. Weekly Total Dose and Cumulative Total Dose (mg/kg) When First Achieving Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)

    Measured: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)

  18. Mean Weekly Dose After Achieving First Hb Response (Hb Increase ≥1 g/dL From Baseline and Hb ≥11 g/dL)

    Measured: Cohorts A and B: Weekly through Week 16 (end of treatment); Cohorts C-F: Weekly through Week 24 (end of treatment)

  19. Change From Baseline in Hb Stratified by Baseline Ferritin >100 Nanograms/Milliliter (ng/mL) and Transferrin Saturation >20% at Week 16 and Week 24

    Baseline was defined as the mean of the last 3 available values predose.

    Measured: Baseline, Weeks 16 (Cohorts A and B End of Treatment) and Week 24 (Cohorts C-F End of Treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2010 (estimated)
  2. Study start29 Oct 2010
  3. Primary completion13 Jun 2012
  4. Study completion13 Jun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01244763
Sponsor's protocol ID
FGCL-4592-041
Status last verified
Jan 2022
First submitted
16 Nov 2010
Last updated
10 Feb 2022
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36005278

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Roxadustat in people with Chronic Kidney Disease and Anemia, run by Kyntra Bio at 38 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number (%) of Participants With an Hb Response by Week 17 (time frame: Up to Week 17). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01244763, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.

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