Anemia Associated With End Stage Renal DiseasePhase 3ASPENNCT04484857
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
A Phase 3 study testing Roxadustat in people with Anemia Associated With End Stage Renal Disease, run by Kyntra Bio at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia Associated With End Stage Renal Disease
- 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
- 283 participants
- Where
- 26 sitesUnited States
- Study dates
- 22 Jul 2020to 17 Sep 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Alaska
Anchorage, Alaska, 99515
Investigational Site
Austin, Texas, 78229
Investigational Site
Cerritos, California, 90703
Investigational Site
Coral Gables, Florida, 33134
Investigator Site
Dallas, Texas, 75237
Investigator Site
Dalton, Georgia, 30720
Investigational Site
Denver, Colorado, 80230
Investigational Site
El Paso, Texas, 79924
Investigator Site
Gallup, New Mexico, 87301
Investigational Site
Hartford, Connecticut, 06112
Investigational Site
Hollywood, Florida, 33024
Investigational Site
Houston, Texas, 77004
Investigational Site
Kansas City, Missouri, 64111
Investigational Site
Las Vegas, Nevada, 89178
Investigational Site
Norfolk, Virginia, 23502
Investigator Site
Pine Bluff, Arkansas, 71603
Investigational Site
Roseville, Michigan, 48066
Investigator Site
San Antonio, Texas, 78202
Investigator Site
San Antonio, Texas, 78211
Investigator Site
San Antonio, Texas, 78221
Investigational Site
San Antonio, Texas, 78229
Investigational Site
San Antonio, Texas, 78251
Investigator Sites
San Antonio, Texas, 78521
Investigational Site
Statesboro, Georgia, 30458
Investigational Site
The Bronx, New York, 10461
Investigational Site
Victorville, California, 92394
About this study
Official title: Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From an Erythropoiesis Stimulating Agent (ESA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients
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.
- Being tested
- Roxadustat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
Roxadustat will be administered per dose and schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Roxadustat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Weeks 16-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start22 Jul 2020
- Primary completion9 Jul 2021
- Study completion17 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anemia Associated With End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Mark Eisner, Study chair, Kyntra Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484857
- Sponsor's protocol ID
- FGCL-4592-096
- Acronym
- ASPEN
- Status last verified
- Jun 2022
- First submitted
- 21 Jul 2020
- Last updated
- 26 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From an Erythropoiesis Stimulating Agent (ESA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients
- ClinicalTrials.gov ID
- NCT04484857
- Acronym / sponsor ID
- ASPEN / FGCL-4592-096
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Posted 26 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roxadustat | Experimental | Drug: RoxadustatParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoxadustatRoxadustat will be administered per dose and schedule specified in the arm description. | Drug | Roxadustat |
Primary outcome
Percentage of Participants With Mean Hb Value ≥10 g/dL
Time frame: Week 16 through Week 24
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.
Mean Hb Change From Baseline to Average Hb From Weeks 16-24
Time frame: Baseline, 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Eisner study chair
Kyntra Bio
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roxadustat in people with Anemia Associated With End Stage Renal Disease, run by Kyntra Bio at 26 sites in United States.
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 6 inclusion and 11 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Jul 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?
Percentage of Participants With Mean Hb Value ≥10 g/dL (time frame: Week 16 through Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2022.