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| Name | Class |
|---|---|
| Collaborative Study Group (CSG) | NETWORK |
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This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.
There will be a screening visit about 4 weeks receiving study drug. Upon qualifying for the study after the screening visit, patients will then be asked to stop taking their current phosphate binder for about 2 weeks. Then, if patients continue to qualify for the study, they will be entered in the study that lasts about 28 days. Study visits will happen every week during the patient's usual dialysis appointments. There will be a total of up to 9 visits for this study, and total participation time could last up to 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 g/day | Experimental | 1 g/day KRX-0502 (ferric citrate) |
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| 6 g/day | Experimental | 6 g/day KRX-0502 (ferric citrate) |
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| 8 g/day | Experimental | 8 g/day KRX-0502 (ferric citrate) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferric citrate | Drug | 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Phosphorus From Baseline to End of Treatment | Mean change from baseline was calculated separately for each treatment arm (LOCF) | Baseline and day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment | Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome. | Baseline and day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia B Lewis, MD | Collaborative Study Group (CSG) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Nephrology | Westminster | Colorado | 80031 | United States | ||
| Pines Clinical Research, Inc. |
| 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. | |
| 23369827 | Derived | Dwyer JP, Sika M, Schulman G, Chang IJ, Anger M, Smith M, Kaplan M, Zeig S, Koury MJ, Blumenthal SS, Lewis JB; Collaborative Study Group. Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. Am J Kidney Dis. 2013 May;61(5):759-66. doi: 10.1053/j.ajkd.2012.11.041. Epub 2013 Jan 29. |
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3 patients were randomized, but withdrew before initiating study treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 g/Day | 1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days |
| FG001 | 6 g/Day | 6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment |
proportion was calculated separately for each treatment arm |
| Baseline and day 28 |
| Pembroke Pines |
| Florida |
| 33028 |
| United States |
| Kidney Care Associates, LLC | Augusta | Georgia | 30901 | United States |
| Circle Medical Management | Chicago | Illinois | 60607 | United States |
| Western New England Renal & Transplant Associates | Springfield | Massachusetts | 01107 | United States |
| Brookdale Physician's Dialysis Associates | Brooklyn | New York | 11212 | United States |
| DCI | Cincinnati | Ohio | 45206 | United States |
| Cleveland Clinical Foundation Fresenius East (Fairhill) | Cleveland | Ohio | 44104 | United States |
| The Ohio State University Cramblett Medical Clinic | Columbus | Ohio | 43210 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37404 | United States |
| Nephrology Associates, PC | Nashville | Tennessee | 37205 | United States |
| Meharry Medical College Clinical Research Center | Nashville | Tennessee | 37208 | United States |
| Vanderbilt University Medical Center Clinical Trials Center | Nashville | Tennessee | 37232-1371 | United States |
| Kidney Associates | Houston | Texas | 77030 | United States |
| Centre Point Dialysis | West Allis | Wisconsin | 53214 | United States |
| RCMI- Clinical Research Center Medical Sciences Campus University of Puerto Rico | Rio Piedras | PR | 00936-5067 | Puerto Rico |
| FG002 | 8 g/Day | 8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 g/Day | 1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days |
| BG001 | 6 g/Day | 6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days |
| BG002 | 8 g/Day | 8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 Serum Phosphorus From Baseline to End of Treatment | Mean change from baseline was calculated separately for each treatment arm (LOCF) | Intent to Treat (ITT) Population | Posted | Mean | Standard Deviation | mg/dL | Baseline and day 28 |
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| Secondary | Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment | Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome. | Intent-to-Treat, includes only subjects that had both baseline and end of study actual values | Posted | Mean | Standard Deviation | mg/dL | Baseline and day 28 |
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| Secondary | Proportion of Patient With a Serum Phosphorus ≤5.5 mg/dL at the End of Treatment | proportion was calculated separately for each treatment arm | Intent-to-Treat | Posted | Number | % of Participants | Baseline and day 28 |
|
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Serious Adverse Events (AEs) were recorded up to 30 days post therapy
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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 | 1g/Day | Participants received 1g tablet of KRX-0502 (ferric citrate) for 4 weeks | 6 | 51 | 34 | 51 | ||
| EG001 | 6g/Day | Participants received 6g tablet of KRX-0502 (ferric citrate) for 4 weeks | 7 | 52 | 43 | 52 | ||
| EG002 | 8g/Day | Participants received 8g tablet of KRX-0502 (ferric citrate) for 4 weeks | 9 | 48 | 41 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive crisis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypertensive emergency | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Subcutaneous absess | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypertensive heart disease | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Haemorrhage intracranial | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Pulmonary Hypotension | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Pulmonary Odema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Renal transplant | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
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| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Blood glucose fluctuation | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Azotaemia | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Faeces discoloured | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Keryx Biopharmaceuticals Inc | 1-844-44-KERYX (1-844-445-3799 | medicalinfo@keryx.com |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Puerto Rico |
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