Anemia Associated With Chronic Kidney Disease (CKD) Clinical Trial
Official title:
A Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Dose Conversion From a Long-acting Erythropoiesis-stimulating Agent (Mircera®) to Three Times Weekly Oral Vadadustat for the Maintenance Treatment of Anemia in Hemodialysis Subjects
| Verified date | December 2023 |
| Source | Akebia Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will be conducted to demonstrate the efficacy and safety of vadadustat administered three times weekly (TIW) compared to a long-acting erythropoiesis-stimulating agent (ESA) (Mircera®) for the maintenance treatment of anemia in hemodialysis participants.
| Status | Completed |
| Enrollment | 456 |
| Est. completion date | January 30, 2023 |
| Est. primary completion date | December 15, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - =18 years of age - Receiving chronic, outpatient in-center hemodialysis three times weekly (TIW) for end-stage kidney disease for at least 12 weeks prior to Screening Visit 1 (SV1) - Currently maintained on Mircera® with at least 2 doses received within 8 weeks prior to Screening Visit 2 (SV2) - Mean Screening hemoglobin (Hb) between 8.5 and 11.0 grams per deciliter (g/dL) (inclusive), as determined by the average of 2 Hb values measured by the central laboratory at least 4 days apart between SV1 and SV2 - Serum ferritin =100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) =20% during Screening - Folate and vitamin B12 measurements = lower limit of normal during Screening Exclusion Criteria: - Anemia due to a cause other than chronic kidney disease (CKD). - Clinically meaningful bleeding event within 8 weeks prior to Baseline - Red blood cell (RBC) transfusion within 8 weeks prior to Baseline - Having received any doses of darbepoetin alfa (Aranesp®) within 4 weeks prior to Baseline - Having received any doses of epoetin alfa (Epogen®) within 1 week prior to Baseline. - Current uncontrolled hypertension. - Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12 weeks prior to or during Screening. - Known hypersensitivity to vadadustat, Mircera®, or any of their excipients. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Alexandria | Virginia |
| United States | Research Site | Arlington | Texas |
| United States | Research Site | Arvada | Colorado |
| United States | Research Site | Athens | Georgia |
| United States | Research Site | Austin | Texas |
| United States | Research Site | Baton Rouge | Louisiana |
| United States | Research Site | Bradenton | Florida |
| United States | Research Site | Brookhaven | Mississippi |
| United States | Research Site | Buford | Georgia |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Columbus | Mississippi |
| United States | Research Site | Columbus | Ohio |
| United States | Research Site | Coral Gables | Florida |
| United States | Research Site#1 | Coral Springs | Florida |
| United States | Research Site#2 | Coral Springs | Florida |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Dalton | Georgia |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | El Centro | California |
| United States | Research Site | Escondido | California |
| United States | Research Site | Fresno | California |
| United States | Research Site | Gallup | New Mexico |
| United States | Research Site | Granada Hills | California |
| United States | Research Site | Hockessin | Delaware |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Huntsville | Alabama |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Kinston | North Carolina |
| United States | Research Site | Kittanning | Pennsylvania |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Macon | Georgia |
| United States | Research Site | Mansfield | Texas |
| United States | Research Site | Mission | Texas |
| United States | Research Site | Nampa | Idaho |
| United States | Research Site | North Platte | Nebraska |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Pine Bluff | Arkansas |
| United States | Research Site | Plymouth | Massachusetts |
| United States | Research Site | Porterville | California |
| United States | Research Site | Portsmouth | New Hampshire |
| United States | Research Site | Raleigh | North Carolina |
| United States | Research Site | Reno | Nevada |
| United States | Research Site | Rochester Hills | Michigan |
| United States | Research Site | Saint Clair Shores | Michigan |
| United States | Research Site | Salem | Virginia |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Antonio | Texas |
| United States | Research Site | San Diego | California |
| United States | Research Site | Shreveport | Louisiana |
| United States | Research Site | Springfield | Massachusetts |
| United States | Research Site | Tupelo | Mississippi |
| United States | Research Site | Woodbridge | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Akebia Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change in hemoglobin (Hb) between Baseline (average pretreatment Hb) and the primary evaluation period (average Hb from Weeks 20 to 26, inclusive) | Baseline; Weeks 20-26 | ||
| Primary | Number of participants with treatment-emergent non-serious adverse events and treatment-emergent serious adverse events | up to Week 56 | ||
| Secondary | Mean change in Hb between Baseline (average pretreatment Hb) and the secondary evaluation period (average Hb from Weeks 46 to 52, inclusive) | Baseline; Weeks 46-52 |