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| Name | Class |
|---|---|
| Akebia Therapeutics | INDUSTRY |
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This study is being conducted to demonstrate the effect of Auryxia, when used as the primary phosphate lowering therapy, on the overall cumulative use of erythropoiesis-stimulating agent and intravenous iron as well as on the laboratory parameters indicative of phosphate and anemia management.
Approximately 200 participants will be randomized 1:1 (stratified by modality and hemoglobin level) to receive either Auryxia or standard of care phosphate lowering therapy to determine the impact of Auryxia when used as the primary phosphate lowering therapy as compared to standard of care on the utilization of erythropoiesis-stimulating agent and intravenous iron in both in-center and home dialysis populations. This study will also seek to determine the impact of Auryxia, when used as the primary phosphate lowering therapy versus standard of care, on the biochemical assessments of serum phosphate and hemoglobin in both in-center and home dialysis populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric citrate (commercially available, Auryxia) | Experimental | Ferric citrate, (commercially available Auryxia), supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks. |
|
| Standard of care phosphate lowering therapy | Active Comparator | Non-Auryxia phosphate-lowering therapy administered as standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Citrate 1 gram Oral Tablet | Drug | Ferric citrate is an iron-based phosphate binder for the treatment of hyperphosphatemia in subjects with dialysis-dependent chronic kidney disease (DD CKD) and for the treatment of iron deficiency anemia (IDA) in subjects with non-dialysis dependent chronic kidney disease (NDD CKD). |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups | Difference in change from baseline period (Month -3 to Day 1) to months 4 to 6 (efficacy evaluation period) in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups. | Baseline period (Month -3 to Day 1) to months 4to 6 (efficacy evaluation period) |
| Difference in mean dose of intravenous iron (milligram per month) between Auryxia and standard of care treatment groups. | Difference in change from baseline period to efficacy evaluation period in mean dose of intravenous iron (milligrams per month) between Auryxia and standard of care treatment groups. | Baseline period (Month -3 to Day 1) to months 4 to6 (efficacy evaluation period) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in hemoglobin measurements | Difference in proportion of measurements with hemoglobin at or above 10.0 grams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period. | Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period). |
| Difference in serum phosphate measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Renal Care - Dimond | Anchorage | Alaska | 99515 | United States | ||
| US Renal Care - Mesa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. | |
| 38972306 | Derived | Block GA, Mizani MR, Broumand V, Newby FD, Erinle A, Arias C, Block M, Brillhart S, Leppink A, Danese M, Dittrich M. A Randomized Trial of the Impact of Ferric Citrate on Erythropoietin and Intravenous Iron Use in Patients Receiving Dialysis. Am J Nephrol. 2024;55(5):520-528. doi: 10.1159/000540227. Epub 2024 Jul 15. |
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|
| Standard of care phosphate-lowering therapy | Drug | Subjects randomized to SOC will continue their currently prescribed dose of phosphate lowering therapy which will be dosed per local standard of care to achieve community target serum phosphate goals. |
|
Difference in proportion of measurements with serum phosphate at or below 5.5 milligrams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period. |
| Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period) |
| Mesa |
| Arizona |
| 85210 |
| United States |
| US Renal Care - Pine Bluff | Pine Bluff | Arkansas | 71603 | United States |
| US Renal Care - Northridge Roscoe | Granada Hills | California | 91325 | United States |
| US Renal Care - Dalton | Dalton | Georgia | 30720 | United States |
| US Renal Care - Major Health | Shelbyville | Indiana | 46176 | United States |
| US Renal Care - Red Rocks | Gallup | New Mexico | 87301 | United States |
| US Renal Care - North Dallas | Dallas | Texas | 75231 | United States |
| Dallas Renal Group | Dallas | Texas | 75237 | United States |
| US Renal Care - Houston Street | San Antonio | Texas | 78202 | United States |
| US Renal Care - Palo Alto | San Antonio | Texas | 78221 | United States |
| US Renal Care - Pleasanton Rd. | San Antonio | Texas | 78221 | United States |
| US Renal Care - Westover Hills | San Antonio | Texas | 78251 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2023 | Sep 19, 2023 | 4 | ||
| Oct 19, 2023 | Nov 9, 2023 | 5 | ||
| Aug 22, 2024 | Sep 16, 2024 | 6 | ||
| Aug 11, 2025 | Aug 12, 2025 | 7 |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D018798 | Anemia, Iron-Deficiency |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C025314 | ferric citrate |
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