- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01357317
Study Comparing Effects of Lanthanum Carbonate Versus Calcium Acetate Versus Dietary Phosphorus Restriction
June 11, 2012 updated by: Salem Veterans Affairs Medical Center
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Csaba P. Kovesdy, M.D.
- Phone Number: 2445 540-982-2463
- Email: Csaba.Kovesdy@va.gov
Study Locations
-
-
Virginia
-
Salem, Virginia, United States, 24153
- Recruiting
- VA Medical Center
-
Principal Investigator:
- Csaba P. Kovesdy, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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%.
|
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 Names:
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 Names:
|
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).
|
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 Names:
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 Names:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Designated safety measure; serum calcium
Time Frame: 1 year compared to day 0
|
Changes in calcium, PTH, FGF-23 at 1 year compared to day 0
|
1 year compared to day 0
|
Designated safety measure: phosphorus
Time Frame: 1 year compared to day 0
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in flow
Time Frame: 1 year compared to day 0
|
Changes in flow mediated vasodilatation at 1 year compared to day 0.
|
1 year compared to day 0
|
Other Changes
Time Frame: 1 year compared to day 0
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Csaba P. Kovesdy, M.D., Salem VAMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Anticipated)
October 1, 2013
Study Completion (Anticipated)
March 1, 2014
Study Registration Dates
First Submitted
April 4, 2011
First Submitted That Met QC Criteria
May 19, 2011
First Posted (Estimate)
May 20, 2011
Study Record Updates
Last Update Posted (Estimate)
June 12, 2012
Last Update Submitted That Met QC Criteria
June 11, 2012
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Renal Insufficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Chelating Agents
- Sequestering Agents
- Calcium
- Calcium, Dietary
- Calcium acetate
Other Study ID Numbers
- CK 0036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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