Anemia Associated With End Stage Renal Disease Clinical Trial
— ASPENOfficial 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
| Verified date | June 2022 |
| Source | FibroGen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 283 |
| Est. completion date | September 17, 2021 |
| Est. primary completion date | July 9, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: - 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 Key Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Alaska | Anchorage | Alaska |
| United States | Investigational Site | Austin | Texas |
| United States | Investigational Site | Bronx | New York |
| United States | Investigational Site | Cerritos | California |
| United States | Investigational Site | Coral Gables | Florida |
| United States | Investigator Site | Dallas | Texas |
| United States | Investigator Site | Dalton | Georgia |
| United States | Investigational Site | Denver | Colorado |
| United States | Investigational Site | El Paso | Texas |
| United States | Investigator Site | Gallup | New Mexico |
| United States | Investigational Site | Hartford | Connecticut |
| United States | Investigational Site | Hollywood | Florida |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Kansas City | Missouri |
| United States | Investigational Site | Las Vegas | Nevada |
| United States | Investigational Site | Norfolk | Virginia |
| United States | Investigator Site | Pine Bluff | Arkansas |
| United States | Investigational Site | Roseville | Michigan |
| United States | Investigational Site | San Antonio | Texas |
| United States | Investigational Site | San Antonio | Texas |
| United States | Investigator Site | San Antonio | Texas |
| United States | Investigator Site | San Antonio | Texas |
| United States | Investigator Site | San Antonio | Texas |
| United States | Investigator Sites | San Antonio | Texas |
| United States | Investigational Site | Statesboro | Georgia |
| United States | Investigational Site | Victorville | California |
| Lead Sponsor | Collaborator |
|---|---|
| FibroGen | AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |