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

NCT01357317 | Unknown Phase 3 DMC

• 1 other identifier: CK 0036
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Kidney disease; Hyperphosphatemia; Parathyroid hormone

Outcome Measures

Primary Outcomes (2)

• Designated safety measure; serum calcium

  Changes in calcium, PTH, FGF-23 at 1 year compared to day 0

  1 year compared to day 0

• 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

Secondary Outcomes (2)

• Changes in flow

  1 year compared to day 0

• Other Changes

  1 year compared to day 0

Study Arms (3)

Lanthanum Carbonate

ACTIVE COMPARATOR

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

Calcium Acetate

ACTIVE COMPARATOR

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

Dietary instructions

ACTIVE COMPARATOR

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

Interventions

Diet counseling OTHER

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).

Also known as: calcium acetate

Lanthanum Carbonate

Phosphorus binder DRUG

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.

Also known as: Lanthanum Carbonate, Calcium Acetate

Dietary instructions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Salem Veterans Affairs Medical Center: lead
• Shire: collaborator

Study Sites (1)

VA Medical Center

Salem, Virginia, 24153, United States

RECRUITING

Related Publications (2)

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

• Kovesdy CP, Lu JL, Wall BM, Gyamlani G, Naseer A, Wallick A, Han Z, Thomas F, Quarles LD, Jarmukli N. Changes With Lanthanum Carbonate, Calcium Acetate, and Phosphorus Restriction in CKD: A Randomized Controlled Trial. Kidney Int Rep. 2018 Mar 23;3(4):897-904. doi: 10.1016/j.ekir.2018.03.011. eCollection 2018 Jul.

  PMID: 29989014 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases; Hyperphosphatemia

Interventions

calcium acetate; lanthanum carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Csaba P. Kovesdy, M.D.

  Salem VAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Csaba P. Kovesdy, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: May 20, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: June 12, 2012

Record last verified: 2011-04

Locations

US (1)