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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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Objective: To examine the effects of three commonly applied treatments of disordered phosphorus homeostasis on biochemical markers and vascular characteristics in patients with moderate and advanced non-dialysis dependent chronic kidney disease.
Approximately 120 qualified patients from our medical center, who have been diagnosed with mild to moderate chronic kidney disease (estimated GFR 15-60 ml/min), will be enrolled. After informed consent, qualified subjects will be randomized into 3 arms in a 1:1:1 ratio: lanthanum carbonate, calcium acetate, and dietary modification. The maximum length of treatment is 12 months. Dose of intervention will be adjusted based on changes in biochemical parameters. Primary end points are changes in serum phosphorus, urine phosphorus, serum parathyroid hormone, coronary artery calcification, aortic pulse velocity and flow mediated vasodilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanthanum Carbonate | Active Comparator | Lanthanum Carbonate: initial dose 500 mg TID with meals, titrated at monthly intervals in 500 mg increments or decrements, with goal of returning to normal the level of the abnormal baseline marker(s) of phosphorus homeostasis (serum phosphorus, PTH or TRP). Normality for this marker will be defined as serum phosphorus of 2.6-4.6 mg/dl, PTH of 10-65pg/ml and TRP>=80%. |
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| Calcium Acetate | Active Comparator | Calcium Acetate: initial dose 667 mg TID with meals, titrated at monthly intervals in 667 mg increments or decrements, with goal of returning to normal the level of the abnormal baseline marker(s) of phosphorus homeostasis. The maximum daily intake of elemental calcium should not exceed 1500 mg in order to comply w/recommendations from K-DOQI [5](this is approximately equal to three 667mg tablets of calcium acetate TID). |
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| Dietary instructions | Active Comparator | Dietary instructions consisting of pamphlets describing foods high in phosphorus and consultation with a renal dietitian if necessary, with the goal of return to normal the level of the abnormal marker of phosphorus homeostasis. Rescue therapy with a phosphorus binder of the treating physician's choice will be allowed in patients who fail to normalize elevated baseline serum phosphorus levels after 3 months following dietary instructions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet counseling | Other | If serum phosphorus level exceeds 4.6 mg/dl in the lanthanum carbonate arm in spite of consecutive up-titration of the medical dose or due to patients' intolerance of the medication, patient will be considered a treatment failure and other treatment options will be implemented, including diet counseling or another class of phosphorus binder (in this order of preference). |
| Measure | Description | Time Frame |
|---|---|---|
| Designated safety measure; serum calcium | Changes in calcium, PTH, FGF-23 at 1 year compared to day 0 | 1 year compared to day 0 |
| Designated safety measure: phosphorus | Changes in serun phosphorus, tubular reabsorption of phosphorus, bone-specific alkaline phosphatase at 1 year compared to day 0 | 1 year compared to day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in flow | Changes in flow mediated vasodilatation at 1 year compared to day 0. | 1 year compared to day 0 |
| Other Changes | Changes in pulse wave velocity, central aortic blood pressure, coronary artery calcification at 1 year compared to day 0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Csaba P. Kovesdy, M.D. | Contact | 540-982-2463 | 2445 | Csaba.Kovesdy@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Csaba P. Kovesdy, M.D. | Salem VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center | Recruiting | Salem | Virginia | 24153 | 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. | |
| 29989014 | Derived | Kovesdy CP, Lu JL, Wall BM, Gyamlani G, Naseer A, Wallick A, Han Z, Thomas F, Quarles LD, Jarmukli N. Changes With Lanthanum Carbonate, Calcium Acetate, and Phosphorus Restriction in CKD: A Randomized Controlled Trial. Kidney Int Rep. 2018 Mar 23;3(4):897-904. doi: 10.1016/j.ekir.2018.03.011. eCollection 2018 Jul. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C120662 | calcium acetate |
| C119467 | lanthanum carbonate |
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| Diet counseling | Other | If serum phosphorus level exceeds 4.6 mg/dl in spite of consecutive up-titration of the medication dose or due to patients' intolerance of the medication, patient will be considered a treatment failure and other treatment options will be implemented, including diet counseling or another class of phosphorus binder (in this order of preference). |
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| Phosphorus binder | Drug | If serum phosphorus level exceeds 4.6 mg/dl after 3 months of concerted efforts, the patient will be considered a treatment failure and treatment with a phosphorus binder of the treating physician's choice will be allowed. |
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| 1 year compared to day 0 |
| 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 |