Renal Insufficiency, ChronicPhase 4LAVALIERNCT02237534
Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia
A Phase 4 study testing Lanthanum carbonate and Calcium Carbonate in people with Renal Insufficiency, Chronic and Hyperphosphatemia, run by Osaka University at 1 site in Japan.
Trial summary
The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Hyperphosphatemia, Bone Diseases, Metabolic
- What is being tested?
- Lanthanum carbonate and Calcium Carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2014to Sep 2023
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL)
- With written informed consent
Who cannot join
- History of cardiac surgery
- With coronary artery stent
- Polycystic kidney disease
- Hypothyroidism
- On treatment with lanthanum carbonate
- History of admission within 3 months
Show all 12Show fewer
- History of ileus
- Severe liver dysfunction
- Severe gastrointestinal dysfunction
- Allergy to lanthanum carbonate or calcium carbonate
- Pregnant or breastfeeding women
- Judged as ineligible by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia
The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.
- Being tested
- Lanthanum carbonate, Calcium Carbonate
- Keywords
- Lanthanum, Calcium Carbonate, Vascular Calcification
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia, Bone Diseases, Metabolic, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum carbonateDrug
Also called FOSRENOL®
Calcium CarbonateDrug
| Study group | Role | What they receive |
|---|---|---|
| Calcium carbonate | Active comparator | Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 3,000 mg/day. Receives: Drug: Calcium Carbonate |
| Lanthanum carbonate | Experimental | Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day. Receives: Drug: Lanthanum carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery calcification score
Measured: 1 year
Secondary outcomes (15)
Endothelial function
Measured by EndoPAT™ (Itamar Medical Ltd.)
Measured: 3 months
Serum bone metabolic markers
Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
Measured: 3 months
Serum bone metabolic markers
Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
Measured: 1 year
Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time
Measured: Up to 1 year
Estimated glomerular filtration rate over time
Measured: Up to 1 year
Bone mineral density
Measured: 1 year
Serum osteoprotegerin concentration
Measured: 3 month
Serum osteoprotegerin concentration
Measured: 1 year
Urinary alpha-Klotho to creatinine ratio
Measured: 3 months
Urinary alpha-Klotho to creatinine ratio
Measured: 1 year
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
Measured: 3 months
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
Measured: 1 year
End-stage renal disease requiring renal replacement therapy
Measured: Up to 1 year
Cardiovascular event requiring hospitalization
Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease
Measured: Up to 1 year
Death
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion31 Mar 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osaka University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Takayuki Hamano, Osaka University
- Investigators
- Takayuki Hamano, MD, PhD, Study chair, Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237534
- Sponsor's protocol ID
- CKDR-002
- Acronym
- LAVALIER
- Status last verified
- Feb 2021
- First submitted
- 9 Sep 2014
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia
- ClinicalTrials.gov ID
- NCT02237534
- Acronym / sponsor ID
- LAVALIER / CKDR-002
- Keywords
- Lanthanum, Calcium Carbonate, Vascular Calcification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Osaka UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2014
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 11 Sep 2014 (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.
The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium carbonate | Active comparator | Drug: Calcium CarbonateStart at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 3,000 mg/day. |
| Lanthanum carbonate | Experimental | Drug: Lanthanum carbonateStart at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL)
- With written informed consent
Key exclusion criteria (12 listed)
- History of cardiac surgery
- With coronary artery stent
- Polycystic kidney disease
- Hypothyroidism
- On treatment with lanthanum carbonate
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 |
|---|---|---|
| Lanthanum carbonateAlso: FOSRENOL® | Drug | Lanthanum carbonate |
| Calcium Carbonate | Drug | Calcium carbonate |
Primary outcome
Coronary artery calcification score
Time frame: 1 year
15 secondary outcomes
Endothelial function
Time frame: 3 months
Serum bone metabolic markers
Time frame: 3 months
Serum bone metabolic markers
Time frame: 1 year
Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time
Time frame: Up to 1 year
Estimated glomerular filtration rate over time
Time frame: Up to 1 year
Bone mineral density
Time frame: 1 year
Serum osteoprotegerin concentration
Time frame: 3 month
Serum osteoprotegerin concentration
Time frame: 1 year
Urinary alpha-Klotho to creatinine ratio
Time frame: 3 months
Urinary alpha-Klotho to creatinine ratio
Time frame: 1 year
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
Time frame: 3 months
Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
Time frame: 1 year
End-stage renal disease requiring renal replacement therapy
Time frame: Up to 1 year
Cardiovascular event requiring hospitalization
Time frame: Up to 1 year
Death
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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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.
Takayuki Hamano, MD, PhD study chair
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lanthanum carbonate and Calcium Carbonate in people with Renal Insufficiency, Chronic and Hyperphosphatemia, run by Osaka University at 1 site in Japan.
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 2 inclusion and 12 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 25 Feb 2021. 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 Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery calcification score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2021.