Chronic Kidney DiseasePhase 3NCT01357317
Study Comparing Effects of Lanthanum Carbonate Versus Calcium Acetate Versus Dietary Phosphorus Restriction
A Phase 3 study testing Diet counseling and Phosphorus binder in people with Chronic Kidney Disease, run by Salem Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Diet counseling and Phosphorus binder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Medical Center
Salem, Virginia, 24153
Csaba P. Kovesdy, M.D.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Diet counseling, Phosphorus binder
- Keywords
- Kidney disease, Hyperphosphatemia, Parathyroid hormone
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet counselingOther
Also called calcium acetate
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 counselingOther
Also called Lanthanum Carbonate
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 binderDrug
Also called Lanthanum Carbonate, Calcium Acetate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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). Receives: 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. Receives: Drug: Phosphorus binder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Designated safety measure; serum calcium
Changes in calcium, PTH, FGF-23 at 1 year compared to day 0
Measured: 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
Measured: 1 year compared to day 0
Secondary outcomes (2)
Changes in flow
Changes in flow mediated vasodilatation at 1 year compared to day 0.
Measured: 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.
Measured: 1 year compared to day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salem Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Shire
- Responsible party
- Sponsor
- Investigators
- Csaba P. Kovesdy, M.D., Principal investigator, Salem VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357317
- Sponsor's protocol ID
- CK 0036
- Status last verified
- Apr 2011
- First submitted
- 4 Apr 2011
- Last updated
- 12 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40576086Kovesdy 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.
PubMed 29989014
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01357317
- Acronym / sponsor ID
- CK 0036
- Conditions
- Chronic Kidney Disease
- Keywords
- Kidney disease, Hyperphosphatemia, Parathyroid hormone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Salem Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Shire
- Study start
- Jun 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lanthanum Carbonate | Active comparator | Other: Diet counselingLanthanum 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 | Active comparator | Other: Diet counselingCalcium 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 | Active comparator | Drug: Phosphorus binderDietary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet counselingAlso: calcium acetateIf 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 | Lanthanum Carbonate |
| Diet counselingAlso: Lanthanum CarbonateIf 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 | Calcium Acetate |
| Phosphorus binderAlso: Lanthanum Carbonate, Calcium AcetateIf 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. | Drug | Dietary instructions |
Primary outcome
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
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
2 secondary outcomes
Changes in flow
Time frame: 1 year compared to day 0
Other Changes
Time frame: 1 year compared to day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2012.
- Derived from this study: PubMed 40576086Natale 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.
- Derived from this study: PubMed 29989014Kovesdy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Csaba P. Kovesdy, M.D. principal investigator
Salem VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diet counseling and Phosphorus binder in people with Chronic Kidney Disease, run by Salem Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Csaba P. Kovesdy, M.D. (540-982-2463 ext. 2445, Csaba.Kovesdy@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Designated safety measure; serum calcium (time frame: 1 year compared to day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357317, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2012.