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

Chronic Kidney Disease Clinical Trial

Official title:

Changes in Biochemical and Vascular Parameters w/Lanthanum Carbonate & Calcium Acetate Therapy Compared to Dietary Intervention in Pts w/Stage 3 & 4 Chronic Kidney Disease & Abnormal Phosphorus Homeostasis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01357317
• Other study ID #: CK 0036
• Status: Recruiting
• Phase: Phase 3
• First received: April 4, 2011
• Last updated: June 11, 2012
• Start date: June 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2011
• Source: Salem Veterans Affairs Medical Center
• Contact: Csaba P. Kovesdy, M.D.
• Phone: 540-982-2463
• Email: Csaba.Kovesdy[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Diet counseling
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).
• Diet counseling
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).

Drug:
• Phosphorus binder
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.

Locations

Country	Name	City	State
United States	VA Medical Center	Salem	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Salem Veterans Affairs Medical Center	Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Designated safety measure; serum calcium	Changes in calcium, PTH, FGF-23 at 1 year compared to day 0	1 year compared to day 0	Yes
Primary	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	Yes
Secondary	Changes in flow	Changes in flow mediated vasodilatation at 1 year compared to day 0.	1 year compared to day 0	Yes
Secondary	Other Changes	Changes in pulse wave velocity, central aortic blood pressure, coronary artery calcification at 1 year compared to day 0.	1 year compared to day 0	Yes