HemodialysisPhase 3LANDMARKNCT01578200
Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study
A Phase 3 study testing Lanthanum Carbonate and Calcium Carbonate in people with Hemodialysis and Hyperphosphatemia, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemodialysis, Hyperphosphatemia
- What is being tested?
- Lanthanum Carbonate and Calcium Carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,309 participants
- Where
- 1 siteJapan
- Study dates
- 24 Dec 2011to 25 Mar 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hemodialysis patients with hyperphosphatemia who require phosphate binders
- hemodialysis for more than 3 months
- patients who have at least one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus)
- intact-PTH < or = 240pg/mL
- life expectancy > 1 year
- with written informed consent
Who cannot join
- contraindications to lanthanum carbonate and calcium carbonate
- swallowing disorders
- severe GI disorders
- history of obstructed bowels
- history of IHD/stroke within 6 months before randomization
- NYHA classification Ⅲ-Ⅳ
Show all 13Show fewer
- severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution
- require treatment of arrhythmia
- severe malnutrition
- malignancy of any type within the last five years
- peritoneal dialysis patients
- pregnant or possibly pregnant women or women on lactation and planned to get pregnant within study term
- ineligible patients according to the investigator's judgment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate on Cardiovascular Mortality and Morbidity in Patients With Chronic Kidney Disease on Hemodialysis (CKD5D)
The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate.
Read the detailed description
Elevated serum phosphate and calcium in dialysis patients are independently associated with increased risk of arterial calcification and mortality. Calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification. A recent randomized study demonstrated that sevelamer, a non-calcium-based phosphate binders, reduced mortality in elderly hemodialysis patients compared with calcium-based phosphate binders. Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder. A post-hoc survival analysis of lanthanum carbonate versus standard therapy suggested a survival benefit of lanthanum carbonate treatment for elderly patients.
- Conditions
- Hemodialysis, Hyperphosphatemia
- Being tested
- Lanthanum Carbonate, Calcium Carbonate
- Keywords
- CKD-MBD, phosphate-binder, vascular calcification, mortality, dialysis, Hemodialysis patients with hyperphosphatemia
- Medical subject headings
- Hyperphosphatemia, Chronic Kidney Disease-Mineral and Bone Disorder, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum CarbonateDrug
Calcium CarbonateDrug
| Study group | Role | What they receive |
|---|---|---|
| Lanthanum carbonate | Experimental | Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg. Receives: Drug: Lanthanum Carbonate |
| Calcium Carbonate | Active comparator | Patients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g. Receives: Drug: Calcium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular event free survival time.
Cardiovascular event consisting of
- death due to cardiovascular diseases including sudden cardiac death (ICD-10 codes R96.0/96.1),
- nonfatal myocardial infarction,
- nonfatal cerebral stroke including transient ischemic attack, TIA,
- unstable angina,
- hospitalization for heart failure,
- hospitalization for ventricular arrhythmia
Measured: 3 years
Secondary outcomes (5)
Overall survival
Measured: 3 years
Secondary hyperparathyroidism free survival
Measured: 3 years
Hip fracture free survival
Measured: 3 years
Quality of life questionnaire (KDQOL-SF, v1.3)
Measured: 3 years
Bone mineral density (DEXA)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study start24 Dec 2011
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
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 HemodialysisStudies 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
- 2,309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Showa University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Tadao Akizawa, MD, PhD, Principal investigator, Showa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578200
- Sponsor's protocol ID
- TRIGU1111
- Other IDs
- UMIN000006815
- Acronym
- LANDMARK
- Status last verified
- Mar 2019
- First submitted
- 13 Apr 2012
- Last updated
- 30 Nov 2020
- Results posted
- No
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 40576086Ogata H, Fukagawa M, Hirakata H, Kagimura T, Fukushima M, Akizawa T; LANDMARK Investigators and Committees. Effect of Treating Hyperphosphatemia With Lanthanum Carbonate vs Calcium Carbonate on Cardiovascular Events in Patients With Chronic Kidney Disease Undergoing Hemodialysis: The LANDMARK Randomized Clinical Trial. JAMA. 2021 May 18;325(19):1946-1954. doi: 10.1001/jama.2021.4807.
PubMed 34003226
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate on Cardiovascular Mortality and Morbidity in Patients With Chronic Kidney Disease on Hemodialysis (CKD5D)
- ClinicalTrials.gov ID
- NCT01578200
- Acronym / sponsor ID
- LANDMARK / TRIGU1111
- Conditions
- Hemodialysis, Hyperphosphatemia
- Keywords
- CKD-MBD, phosphate-binder, vascular calcification, mortality, dialysis, Hemodialysis patients with hyperphosphatemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,309 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Showa University School of Medicine
- Study start
- 24 Dec 2011
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 16 Apr 2012 (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 demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate.
Detailed description
Elevated serum phosphate and calcium in dialysis patients are independently associated with increased risk of arterial calcification and mortality. Calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification. A recent randomized study demonstrated that sevelamer, a non-calcium-based phosphate binders, reduced mortality in elderly hemodialysis patients compared with calcium-based phosphate binders. Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder. A post-hoc survival analysis of lanthanum carbonate versus standard therapy suggested a survival benefit of lanthanum carbonate treatment for elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lanthanum carbonate | Experimental | Drug: Lanthanum CarbonatePatients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg. |
| Calcium Carbonate | Active comparator | Drug: Calcium CarbonatePatients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- hemodialysis patients with hyperphosphatemia who require phosphate binders
- hemodialysis for more than 3 months
- patients who have at least one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus)
- intact-PTH < or = 240pg/mL
- life expectancy > 1 year
Key exclusion criteria (13 listed)
- contraindications to lanthanum carbonate and calcium carbonate
- swallowing disorders
- severe GI disorders
- history of obstructed bowels
- history of IHD/stroke within 6 months before randomization
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 Carbonate | Drug | Lanthanum carbonate |
| Calcium Carbonate | Drug | Calcium Carbonate |
Primary outcome
Cardiovascular event free survival time.
Time frame: 3 years
Cardiovascular event consisting of 1. death due to cardiovascular diseases including sudden cardiac death (ICD-10 codes R96.0/96.1), 2. nonfatal myocardial infarction, 3. nonfatal cerebral stroke including transient ischemic attack, TIA, 4. unstable angina, 5. hospitalization for heart failure, 6. hospitalization for ventricular arrhythmia
5 secondary outcomes
Overall survival
Time frame: 3 years
Secondary hyperparathyroidism free survival
Time frame: 3 years
Hip fracture free survival
Time frame: 3 years
Quality of life questionnaire (KDQOL-SF, v1.3)
Time frame: 3 years
Bone mineral density (DEXA)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- 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 34003226Ogata H, Fukagawa M, Hirakata H, Kagimura T, Fukushima M, Akizawa T; LANDMARK Investigators and Committees. Effect of Treating Hyperphosphatemia With Lanthanum Carbonate vs Calcium Carbonate on Cardiovascular Events in Patients With Chronic Kidney Disease Undergoing Hemodialysis: The LANDMARK Randomized Clinical Trial. JAMA. 2021 May 18;325(19):1946-1954. doi: 10.1001/jama.2021.4807.
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
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.
Tadao Akizawa, MD, PhD principal investigator
Showa University
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 Lanthanum Carbonate and Calcium Carbonate in people with Hemodialysis and Hyperphosphatemia, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 30 Nov 2020. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiovascular event free survival time. (time frame: 3 years). 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 NCT01578200, 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 30 Nov 2020.