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

Status unconfirmed · Phase 3

Conditions studied: Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT01357317

Run by

Salem Veterans Affairs Medical Center

People needed

120

Starts

2011-06-01

Expected to finish

2014-03-01

Last updated by the study team

2012-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• VA Medical Center — Salem, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.