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

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salem Veterans Affairs Medical Center
• Collaborator: Shire
• Treatments: Calcium; Calcium acetate; Calcium, Dietary

Criteria

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.