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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Salem Veterans Affairs Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Salem Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01357317
First received: April 4, 2011
Last updated: June 11, 2012
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Other: Diet counseling
Drug: Phosphorus binder
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Salem Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Designated safety measure; serum calcium [ Time Frame: 1 year compared to day 0 ] [ Designated as safety issue: Yes ]
    Changes in calcium, PTH, FGF-23 at 1 year compared to day 0

  • Designated safety measure: phosphorus [ Time Frame: 1 year compared to day 0 ] [ Designated as safety issue: Yes ]
    Changes in serun phosphorus, tubular reabsorption of phosphorus, bone-specific alkaline phosphatase at 1 year compared to day 0


Secondary Outcome Measures:
  • Changes in flow [ Time Frame: 1 year compared to day 0 ] [ Designated as safety issue: Yes ]
    Changes in flow mediated vasodilatation at 1 year compared to day 0.

  • Other Changes [ Time Frame: 1 year compared to day 0 ] [ Designated as safety issue: Yes ]
    Changes in pulse wave velocity, central aortic blood pressure, coronary artery calcification at 1 year compared to day 0.


Estimated Enrollment: 120
Study Start Date: June 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lanthanum Carbonate
Lanthanum Carbonate: initial dose 500 mg TID with meals, titrated at monthly intervals in 500 mg increments or decrements, with goal of returning to normal the level of the abnormal baseline marker(s) of phosphorus homeostasis (serum phosphorus, PTH or TRP). Normality for this marker will be defined as serum phosphorus of 2.6-4.6 mg/dl, PTH of 10-65pg/ml and TRP>=80%.
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).
Other Name: calcium acetate
Active Comparator: Calcium Acetate
Calcium Acetate: initial dose 667 mg TID with meals, titrated at monthly intervals in 667 mg increments or decrements, with goal of returning to normal the level of the abnormal baseline marker(s) of phosphorus homeostasis. The maximum daily intake of elemental calcium should not exceed 1500 mg in order to comply w/recommendations from K-DOQI [5](this is approximately equal to three 667mg tablets of calcium acetate TID).
Other: 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).
Other Name: Lanthanum Carbonate
Active Comparator: Dietary instructions
Dietary instructions consisting of pamphlets describing foods high in phosphorus and consultation with a renal dietitian if necessary, with the goal of return to normal the level of the abnormal marker of phosphorus homeostasis. Rescue therapy with a phosphorus binder of the treating physician's choice will be allowed in patients who fail to normalize elevated baseline serum phosphorus levels after 3 months following dietary instructions.
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.
Other Names:
  • Lanthanum Carbonate
  • Calcium Acetate

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357317

Contacts
Contact: Csaba P. Kovesdy, M.D. 540-982-2463 ext 2445 Csaba.Kovesdy@va.gov

Locations
United States, Virginia
VA Medical Center Recruiting
Salem, Virginia, United States, 24153
Principal Investigator: Csaba P. Kovesdy, M.D.         
Sponsors and Collaborators
Salem Veterans Affairs Medical Center
Shire
Investigators
Principal Investigator: Csaba P. Kovesdy, M.D. Salem VAMC
  More Information

No publications provided

Responsible Party: Salem Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01357317     History of Changes
Other Study ID Numbers: CK 0036
Study First Received: April 4, 2011
Last Updated: June 11, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Salem Veterans Affairs Medical Center:
Kidney disease
Hyperphosphatemia
Parathyroid hormone

Additional relevant MeSH terms:
Calcium, Dietary
Calcium acetate
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 10, 2014