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

Primary Purpose

Chronic Kidney Disease

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diet counseling
Diet counseling
Phosphorus binder
Sponsored by
Salem Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Kidney disease, Hyperphosphatemia, Parathyroid hormone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lanthanum Carbonate

Calcium Acetate

Dietary instructions

Arm Description

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%.

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).

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.

Outcomes

Primary Outcome Measures

Designated safety measure; serum calcium
Changes in calcium, PTH, FGF-23 at 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

Secondary Outcome Measures

Changes in flow
Changes in flow mediated vasodilatation at 1 year compared to day 0.
Other Changes
Changes in pulse wave velocity, central aortic blood pressure, coronary artery calcification at 1 year compared to day 0.

Full Information

First Posted
April 4, 2011
Last Updated
June 11, 2012
Sponsor
Salem Veterans Affairs Medical Center
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01357317
Brief Title
Study Comparing Effects of Lanthanum Carbonate Versus Calcium Acetate Versus Dietary Phosphorus Restriction
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Salem Veterans Affairs Medical Center
Collaborators
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Kidney disease, Hyperphosphatemia, Parathyroid hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lanthanum Carbonate
Arm Type
Active Comparator
Arm Description
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%.
Arm Title
Calcium Acetate
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Dietary instructions
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diet counseling
Other Intervention Name(s)
calcium acetate
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Diet counseling
Other Intervention Name(s)
Lanthanum Carbonate
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Phosphorus binder
Other Intervention Name(s)
Lanthanum Carbonate, Calcium Acetate
Intervention Description
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 Information:
Title
Designated safety measure; serum calcium
Description
Changes in calcium, PTH, FGF-23 at 1 year compared to day 0
Time Frame
1 year compared to day 0
Title
Designated safety measure: phosphorus
Description
Changes in serun phosphorus, tubular reabsorption of phosphorus, bone-specific alkaline phosphatase at 1 year compared to day 0
Time Frame
1 year compared to day 0
Secondary Outcome Measure Information:
Title
Changes in flow
Description
Changes in flow mediated vasodilatation at 1 year compared to day 0.
Time Frame
1 year compared to day 0
Title
Other Changes
Description
Changes in pulse wave velocity, central aortic blood pressure, coronary artery calcification at 1 year compared to day 0.
Time Frame
1 year compared to day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Csaba P. Kovesdy, M.D.
Phone
540-982-2463
Ext
2445
Email
Csaba.Kovesdy@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Csaba P. Kovesdy, M.D.
Organizational Affiliation
Salem VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Csaba P. Kovesdy, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
29989014
Citation
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.
Results Reference
derived

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

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