Recruiting
Phase 3

Lanthanum Carbonate, Calcium Acetate, Dietary Phosphorus Restriction

Sponsor:

Salem Veterans Affairs Medical Center

Code:

NCT01357317

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet counseling

Diet counseling

Phosphorus binder

Study Details

Brief 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.

Conditions

Chronic Kidney Disease

Study ID

NCT01357317

Start date

Jun, 2011

Status verified date

Apr, 2011

Completion date

Mar, 2014

Anticipated

Primary completion date

Oct, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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%.

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).

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.

Interventions

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).

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.

Primary outcome measure

  • Designated safety measure; serum calcium [ Time Frame: 1 year compared to day 0 ]
  • Designated safety measure: phosphorus [ Time Frame: 1 year compared to day 0 ]

Central Contacts and Locations

Central contacts

Csaba P. Kovesdy, M.D.

540-982-2463Csaba.Kovesdy@va.gov

Locations

VA Medical Center

Recruiting

Salem, Virginia, United States, 24153

Principal Investigator:

Csaba P. Kovesdy, M.D.

More Information

Sponsor

Salem Veterans Affairs Medical Center

Last update posted

Jun 12, 2012

Last verified

Apr, 2011

Keywords

  • Kidney disease
  • Hyperphosphatemia
  • Parathyroid hormone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Salem Veterans Affairs Medical Center on 2012-06-12.