Study Comparing Effects of Lanthanum Carbonate Versus Calcium Acetate Versus Dietary Phosphorus Restriction
Study Comparing Effects of Lanthanum Carbonate Versus Calcium Acetate Versus Dietary Phosphorus Restriction
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.
Inclusion Criteria:

 -  Male or female CKD patients > 18 years old

 -  Patients should be willing and able to provide written informed consent and HIPAA
 authorization to participate in study

 -  Chronic kidney disease Stage 3 or 4 per K-DOQI Guidelines: estimated glomerular
 filtration rate (eGFR) of 15-60 ml/.min/1.73m2 by using modified MDRD equation.

 -  Serum phosphorus >4.6 mg/dl or plasma intact PTH (iPTH) level above 65 pg/ml or
 tubular reabsorption of phosphorus (TRP) <80%.

 -  A negative pregnancy test prior to enrollment in female patients, unless the patient
 is 2 years postmenopausal, or has had a documented tubal ligation or total
 hysterectomy.

 -  Patients need to be off any phosphorus binders for 4 weeks prior to screening

 -  Stable dose of vitamin D products for 4 weeks in patients receiving such agents. Dose
 changes in patients receiving stable and initiation of vitamin D products in patients
 previously not treated will not be permitted during study

 Exclusion Criteria:

 -  Women who are pregnant, capable of becoming pregnant and not participating in an
 acceptable form of birth control, or who are breast feeding

 -  Patients currently participating in a clinical trial with another investigational drug
 or device or who have receiving an investigational drug or device within 30 days of
 enrollment in this study

 -  Major surgery within 2 month prior to enrollment in study or planned surgery while the
 patient is in the study, other than dialysis vascular access surgery.

 -  Presence of coronary stents, artificial heart valves or pacemakers, and history of
 CABG

 -  Patients with active infections requiring ongoing treatment

 -  Patients who have had a malignancy (except for non-melanoma cancer of the skin) unless
 the patient has received curative treatment and has been disease free for >2 years

 -  Patient who the Investigator determines has a medical status that would preclude the
 patient's participation in the study

 -  Patients on hemodialysis (HD) or peritoneal dialysis (PD)

 -  Patients with a functional renal transplant

 -  Patients with allergies to study drugs

 -  Patients with serum calcium >10.7 mg/dl.