Anemia Associated With End Stage Renal Disease (ESRD) Clinical Trial
Official title:
A Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From a Continuous Erythropoietin Receptor Activator (CERA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients - DENALI Study
| Verified date | August 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 chronic dialysis participants converted from ESA therapy or who are ESA-naïve.
| Status | Completed |
| Enrollment | 203 |
| Est. completion date | October 11, 2021 |
| Est. primary completion date | June 30, 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 tunneled catheter - Screening hemoglobin criteria (based on central lab value; measured within 10 days prior to initiating Roxadustat treatment: Participants converting from CERA: screening heamoglobin was between 9.0 to 12.0 g/dL; Participants initiating anemia treatment: <10.0 g/dL - Ferritin = 50 nanograms (ng)/milliliter (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 (MI), 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 - Diagnosis or suspicion of renal cell carcinoma as shown on renal imaging performed within 24 weeks prior to enrollment - 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 | Investigational Site | Baton Rouge | Louisiana |
| United States | Investigational Site | Caldwell | Idaho |
| United States | Investigational Site | Englewood | Colorado |
| United States | Investigational Site | Kalamazoo | Michigan |
| United States | Investigational Site | Las Vegas | Nevada |
| United States | Investigational Site | Saint Ann | Missouri |
| United States | Investigational Site | Saint George | Utah |
| United States | Investigational Site | Sugar Land | Texas |
| United States | Investigational Site | Tupelo | Mississippi |
| 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. 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 |