Not provided
Not provided
Not provided
Not provided
Not provided
38 enrolled, 19 completed the study when loss of funding occurred
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Keryx Biopharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
In patients with end stage renal disease (ESRD) receiving dialysis, the risk of cardiovascular death has been estimated to be 10-100 times higher than the general population without renal disease. This is due in part to high levels of inflammation and vascular calcification (large deposits of calcium in arteries) found in these patients. Chronic inflammation is particularly common in patients with ESRD. Parenteral iron therapy, which is common in patients on dialysis, may contribute to this inflammation and also a higher cardiovascular risk. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. In a study of 10,044 hemodialysis patients, treatment with a phosphate binder was associated with improved survival. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. It has been shown to improve serum phosphorus levels and decrease intravenous iron requirements for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
Ferric citrate has the potential to decrease cardiovascular risk through multiple mechanisms:
The purpose of this study is to examine the effect of ferric citrate on inflammatory markers and lipid levels.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Citrate | Other | Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Citrate | Drug | Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and < 50% and ferritin ≥ 200 and < 500 ng/ml after a 2 week wash out period. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Total Cholesterol | Percent change in total cholesterol (mg/dl) from Baseline to Month 6. | Baseline, Month 6 |
| Percent Change in LDL-Cholesterol | Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6 | Baseline, Month 6 |
| Percent Change in HDL Cholesterol | Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6. | Baseline, Month 6 |
| Percent Change in Triglycerides | Percent change in triglycerides (mg/dl) from baseline to Month 6. | Baseline, Month 6 |
| Percent Change in TNF-alpha | Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6. | Baseline, Month 6 |
| Percent Change in IL-6 | Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6 | Baseline, Month 6 |
| Percent Change in IL-8 | Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6. | Baseline, Month 6 |
| Percent Change in Ferritin |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Calcium | Percent change in calcium (mg/dL) from baseline to Month 6. | Baseline, Month 6 |
| Percent Change in Phosphorus | Percent change in phosphorus (md/dl) from baseline to Month 6. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Candace Grant, MD | NYU Winthrop | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Citrate | Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. Ferric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and < 50% and ferritin ≥ 200 and < 500 ng/ml after a 2 week wash out period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Citrate | Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants. Ferric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and < 50% and ferritin ≥ 200 and < 500 ng/ml after a 2 week wash out period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change in Total Cholesterol | Percent change in total cholesterol (mg/dl) from Baseline to Month 6. | Posted | Mean | Standard Deviation | Percent change | Baseline, Month 6 |
|
|
6 months
Not provided
Not provided
| 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 at a starting dose of 2 tablets with each meal will be given to all participants. Ferric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and < 50% and ferritin ≥ 200 and < 500 ng/ml after a 2 week wash out period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal transplant | Renal and urinary disorders | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Candace Grant, MD | NYU Langone Health | 516-663-0333 | 9054 | candace.grant@nyulangone.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2017 | Mar 30, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C025314 | ferric citrate |
Not provided
Not provided
Not provided
This study will be designed as a single arm, prospective, experimental trial of 45 hemodialysis patients. Patients on hemodialysis at least 6 months and receiving a phosphate binder with serum phosphorus levels between 2.5 and 8.0 mg/dL, normal serum calcium levels, and on maintenance iron therapy are potentially eligible. Participants will receive ferric citrate after at least a 2 week washout period from previous phosphate binders if phosphorus is ≥ 5.5 mg/dl, calcium is within the normal range and ferritin ≥ 200 and < 600 ng/ml. Ferric citrate will be titrated to maintain serum phosphorus and calcium within acceptable levels. Inflammatory markers and lipid levels will be tested at 0, 3, and 6 months.
Not provided
Not provided
Not provided
Not provided
|
|
Percent change in ferritin (ng/ml) from baseline to Month 6.
| Baseline, Month 6 |
| Percent Change in C-reactive Protein | Percent change in C-reactive Protein (mg/L) from baseline to Month 6. | Baseline, Month 6 |
| Percent Change in Homocysteine | Percent change in homocysteine (micromol/L) from baseline to Month 6. | Baseline, Month 6 |
| Change in Intravenous Iron Use | Change in intravenous iron use (mg) from Baseline to Month 6. | Baseline, Month 6 |
| Baseline, Month 6 |
| Percent Change in Parathyroid Hormone (PTH) | Percent change in PTH (pg/ml) from baseline to Month 6. | Baseline, Month 6 |
| Withdrawn due to side effects |
|
| Withdrawn due to access type |
|
| Withdrawn due to allergies |
|
| Withdrawn due to non-compliance |
|
| Withdrawal by Subject |
|
| Failed screening |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Percent Change in LDL-Cholesterol | Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6 | Posted | Mean | Standard Deviation | Percent change | Baseline, Month 6 |
|
|
|
| Primary | Percent Change in HDL Cholesterol | Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
|
|
|
| Primary | Percent Change in Triglycerides | Percent change in triglycerides (mg/dl) from baseline to Month 6. | Posted | Mean | Standard Deviation | Percent change | Baseline, Month 6 |
|
|
|
| Primary | Percent Change in TNF-alpha | Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
|
|
|
| Primary | Percent Change in IL-6 | Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6 | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
|
|
|
| Primary | Percent Change in IL-8 | Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6. | Posted | Mean | Standard Deviation | Percent change | Baseline, Month 6 |
|
|
|
| Primary | Percent Change in Ferritin | Percent change in ferritin (ng/ml) from baseline to Month 6. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
|
|
|
| Primary | Percent Change in C-reactive Protein | Percent change in C-reactive Protein (mg/L) from baseline to Month 6. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
|
|
|
| Primary | Percent Change in Homocysteine | Percent change in homocysteine (micromol/L) from baseline to Month 6. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 6 |
|
|
|
| Primary | Change in Intravenous Iron Use | Change in intravenous iron use (mg) from Baseline to Month 6. | Posted | Mean | Standard Deviation | mg | Baseline, Month 6 |
|
|
|
| Secondary | Percent Change in Calcium | Percent change in calcium (mg/dL) from baseline to Month 6. | Posted | Mean | Standard Deviation | Percent change | Baseline, Month 6 |
|
|
|
| Secondary | Percent Change in Phosphorus | Percent change in phosphorus (md/dl) from baseline to Month 6. | Posted | Mean | Standard Deviation | Percent change | Baseline, Month 6 |
|
|
|
| Secondary | Percent Change in Parathyroid Hormone (PTH) | Percent change in PTH (pg/ml) from baseline to Month 6. | Posted | Mean | Standard Deviation | Percent change | Baseline, Month 6 |
|
|
|
| 1 |
| 38 |
| 14 |
| 38 |
| 0 |
| 38 |
| Coronary artery bypass graft | Cardiac disorders | Non-systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Encephalomalacia | Nervous system disorders | Non-systematic Assessment |
|
| Spinal Stenosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fluid overload | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Catheter infection | Product Issues | Non-systematic Assessment |
|
Not provided
Not provided
| 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 |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |