Study Comparing Effects of Lanthanum Carbonate Versus Calcium Acetate Versus Dietary Phosphorus Restriction

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.