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a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). The study will consist of 14 clinic visits over a period of 24 weeks. There will be a screening period of up to 14 days; Approximately 230 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either KRX-0502 or matching placebo, at baseline
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRX-0502 (ferric citrate) | Experimental | 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron |
|
| Placebo | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferric citrate | Drug | 1 g ferric citrate containing approximately 210 mg of ferric iron |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period | Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline | The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry. | Baseline and week 16 |
| Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Block, MD | Denver Nephrology | Study Chair |
| Glenn Chertow, MD | Division of Nephrology at Stanford University School of Medicine | Study Chair |
| Steven Fishbane, MD | Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKDHC Medical Research Services, LLC | Phoenix | Arizona | 85027 | United States | ||
| Southwest Kidney Institute |
| 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. |
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1 randomized subject was excluded because they did not receive study drug and were excluded from the safety population.
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| ID | Title | Description |
|---|---|---|
| FG000 | KRX-0502 (Ferric Citrate) | 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Matching placebo |
|
The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged. |
| Baseline and week 16 |
| Mean Change in Ferritin at the End of 16 Weeks Minus Baseline | The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry. | Baseline and week 16 |
| Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb) | Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period | Week 16 |
| Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline | The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry. | Baseline and week 16 |
| Tempe |
| Arizona |
| 85284 |
| United States |
| California Renal Research | Glendale | California | 91204 | United States |
| Southern California Medical Research Center | La Palma | California | 90623 | United States |
| Academic Medical Research Institute, Inc | Los Angeles | California | 90022 | United States |
| Apex Research of Riverside | Riverside | California | 92505 | United States |
| Capital Nephrology Medical Group | Sacramento | California | 95825 | United States |
| La Jolla Clinical Research, Inc | San Diego | California | 92103 | United States |
| California Institute of Renal Research | San Diego | California | 92123 | United States |
| Denver Nephrology | Denver | Colorado | 80230 | United States |
| Creekside Medical Research | DeLand | Florida | 32123 | United States |
| Riverside Clinical Research | Edgewater | Florida | 32132 | United States |
| Pines Clinical Research, Inc | Pembroke Pines | Florida | 33028 | United States |
| Kidney Care Associates, LLC | Augusta | Georgia | 30909 | United States |
| Renal Physicians of Georgia, PC | Macon | Georgia | 31217 | United States |
| Pacific Renal Research Institute | Meridian | Idaho | 83642 | United States |
| Advanced Renal Care | Evergreen Park | Illinois | 60805 | United States |
| Kansas Nephrology Research Institute | Wichita | Kansas | 67214 | United States |
| Renal Associates of Baton Rouge | Baton Rouge | Louisiana | 70808 | United States |
| Western New England Renal & Transplant Associates | Springfield | Massachusetts | 01107 | United States |
| Renaissance Renal Research | Detroit | Michigan | 48236 | United States |
| Michigan Kidney Consultants, PC | Pontiac | Michigan | 48341 | United States |
| Clinical Research Consultants | Kansas City | Missouri | 64111 | United States |
| Lincoln Nephrology & Hypertension | Lincoln | Nebraska | 68105 | United States |
| Sierra Nevada Nephrology Asoociates | Reno | Nevada | 89519 | United States |
| Mountain Kidney & Hypertension Associates | Asheville | North Carolina | 28801 | United States |
| Metrolina Nephrology | Charlotte | North Carolina | 28204 | United States |
| Research Management, Inc | Austin | Texas | 78732 | United States |
| Research Management, Inc. | Austin | Texas | 78758 | United States |
| TAD Clinical Research | Lufkin | Texas | 75904 | United States |
| Kidney & Hypertension Specialists | San Antonio | Texas | 78207 | United States |
| Clinical Advancement Center | San Antonio | Texas | 78215 | United States |
| San Antonio Kidney Disease Center | San Antonio | Texas | 78229 | United States |
| Mendez Center for Clinical Research | Alexandria | Virginia | 22304 | United States |
| Nephrology Associates of Northern VA, Inc. | Fairfax | Virginia | 22033 | United States |
| Peninsula Kidney Associates | Hampton | Virginia | 23666 | United States |
Matching Placebo
Placebo: Matching placebo
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | KRX-0502 (Ferric Citrate) | 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron |
| BG001 | Placebo | Matching Placebo Placebo: Matching placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period | Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period. | Posted | Count of Participants | Participants | Week 16 |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline | The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry. | Posted | Least Squares Mean | Standard Error | g/dL | Baseline and week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline | The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged. | Posted | Least Squares Mean | Standard Error | % saturation | Baseline and week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change in Ferritin at the End of 16 Weeks Minus Baseline | The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline and week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb) | Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period | Posted | Count of Participants | Participants | Week 16 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline | The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline and week 16 |
|
|
16 Week Randomized Period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KRX-0502 (Ferric Citrate) | 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron ferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron | 2 | 117 | 14 | 117 | 61 | 117 |
| EG001 | Placebo | Matching Placebo Placebo: Matching placebo | 0 | 116 | 13 | 116 | 41 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron Deficiency Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
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| Cardio-Respiratory Arrest | Cardiac disorders | Systematic Assessment |
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| Sick Sinus Syndrome | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Failure Acute | Cardiac disorders | Systematic Assessment |
| ||
| Colitis Ischaemic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Necrosis | General disorders | Systematic Assessment |
| ||
| Cholangitis Acute | Hepatobiliary disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Clostridium Difficle Colitis | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Abscess Limb | Infections and infestations | Systematic Assessment |
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| Diverticulitis | Infections and infestations | Systematic Assessment |
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| Septic Shock | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection Fungal | Infections and infestations | Systematic Assessment |
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| Celluitis | Infections and infestations | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | Systematic Assessment |
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| Pyelonephritis Acute | Infections and infestations | Systematic Assessment |
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| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural Haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural Nausea | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural Vomiting | Injury, poisoning and procedural complications | Systematic Assessment |
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| Blood Glucose Increased | Investigations | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Diabetic Ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Fluid Overload | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Metabolic Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Status Epilepticus | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | Systematic Assessment |
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| Renal Failure Chronic | Renal and urinary disorders | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
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| Renal Impairment | Renal and urinary disorders | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chronic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Toe Amputation | Surgical and medical procedures | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Faeces Discoloured | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keryx Medical Information | Keryx Biopharmaceuticals, Inc. | 1-844-44-KERYX (844-445-3799) | medicalinfo@keryx.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C025314 | ferric citrate |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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