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The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.
This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Citrate | Experimental | Ferric citrate will be taken with or within one hour of meals or snacks. The starting dose of ferric citrate is 3 tablets/day and titrated by the subject's serum phosphorus results at each treatment visit. |
|
| Placebo | Placebo Comparator | Placebo will be taken with or within one hour of meals or snacks. The starting dose of placebo is 3 tablets per day and titrated by the subject's serum phosphorus results at each treatment visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Citrate | Drug | Dose depends on serum phosphorus levels collected at each study visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment | The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement. | 12 Weeks |
| Change in Serum Phosphorus Levels From Baseline to End of Treatment | The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ferritin Levels From Baseline to End of Treatment | The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement. | 12 Weeks |
| Change in Hemoglobin Levels From Baseline to End of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey Block, MD | Study Chair | |
| Glenn Chertow, MD | Study Chair | |
| Steven Fishbane, MD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States | ||||
| 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. | |
| 25468387 | Derived | Block GA, Fishbane S, Rodriguez M, Smits G, Shemesh S, Pergola PE, Wolf M, Chertow GM. A 12-week, double-blind, placebo-controlled trial of ferric citrate for the treatment of iron deficiency anemia and reduction of serum phosphate in patients with CKD Stages 3-5. Am J Kidney Dis. 2015 May;65(5):728-36. doi: 10.1053/j.ajkd.2014.10.014. Epub 2014 Nov 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Citrate | Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit. Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug |
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The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement. |
| 12 Weeks |
| La Mesa |
| California |
| United States |
| Sacramento | California | United States |
| Denver | Colorado | United States |
| Edgewater | Florida | United States |
| Miami | Florida | United States |
| Meridian | Idaho | United States |
| Evergreen Park | Illinois | United States |
| Bethesda | Maryland | United States |
| Springfield | Massachusetts | United States |
| Detroit | Michigan | United States |
| Pontiac | Michigan | United States |
| Reno | Nevada | United States |
| Great Neck | New York | United States |
| Mineola | New York | United States |
| Asheville | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Orangeburg | South Carolina | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Placebo |
Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit. Placebo |
| COMPLETED |
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| NOT COMPLETED |
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One subject on placebo was randomized but never received drug and so was excluded from the safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Citrate | Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit. Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit. |
| BG001 | Placebo | Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit. 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 |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Chronic kidney disease (CKD), stage at baseline | The stage of CKD disease was measured by the estimated glomerular filtration rate (eGFR), where CKD Stage III relates to better kidney function compare to CKD Stage V, that has worse kidney function. Stage III: eGFR 30-59 mL/min/1.73 m2 Stage IV eGFR 15-29 mL/min/1.73 m2 Stage V eGFR<15 mL/min/1.73 m2 Other eGFR >=60 mL/min/1.73 m2 | 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 | Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment | The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement. | Efficacy analyses were based on Intent-to-Treat (ITT) population, which consisted of all randomized subjects who had a baseline laboratory value, had taken at least 1 dose of study drug, & had at least 1 post-baseline laboratory value. ANCOVA with Last observation carried forward (LOCF) methodology was used. | Posted | Mean | Standard Deviation | % saturation | 12 Weeks |
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| Primary | Change in Serum Phosphorus Levels From Baseline to End of Treatment | The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement. | The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used. | Posted | Mean | Standard Deviation | mg/dL | 12 Weeks |
|
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| Secondary | Change in Ferritin Levels From Baseline to End of Treatment | The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement. | The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used. | Posted | Mean | Standard Deviation | ng/mL | 12 Weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Hemoglobin Levels From Baseline to End of Treatment | The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement. | The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used. | Posted | Mean | Standard Deviation | g/dL | 12 Weeks |
|
|
12 weeks
One subject on placebo was randomized but never received drug and so was excluded from the safety population
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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 | Ferric Citrate | Ferric citrate will be taken with or within one hour of meals or snacks. The dose of ferric citrate will depend on the patient's serum phosphorus results at each treatment visit. Ferric Citrate: Dose depends on serum phosphorus levels collected at each study visit. | 0 | 75 | 6 | 75 | 52 | 75 |
| EG001 | Placebo | Placebo will be taken with or within one hour of meals or snacks. The number of placebo pills will depend on the patient's serum phosphorus results at each treatment visit. Placebo | 2 | 73 | 9 | 73 | 43 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Congestive Cardiac Failure | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| COPD | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Accelerated Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faeces Discolored | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Oedema | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Foot Fracture | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keryx Medical Information | Keryx Biopharmaceuticals | 1-844-44-KERYX (844-445-3799) | medicalinfo@keryx.com |
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D018798 | Anemia, Iron-Deficiency |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| 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 |
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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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| Stage IV |
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| Stage V |
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| Other |
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