Secondary HyperoxaluriaPhase 3LaCaNCT03346369
Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis
A Phase 3 study testing Lanthanum Carbonate in people with Secondary Hyperoxaluria and Nephrolithiasis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperoxaluria, Nephrolithiasis
- What is being tested?
- Lanthanum Carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Aug 2017to 10 Oct 2024
- 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
- able to give written informed consenct
- hyperoxaluria (defined as urinary oxalate > 45 mg/24 hours), demonstrated on 24-hour urine collection within 18 months prior to baseline visit
- history of nephrolithiasis eGFR > 60 mL/min/1.73m² (CKD-EPI formula)
Who cannot join
- primary hyperoxaluria, diagnosed by genetic testing
- known allergy to Lanthanum Carbonate
- hypophosphatemia (defined as serum phosphorus < 0.81 mmol/L)
- severe known liver insufficiency of biliary obstruction
- rectocolitis ulcerohaemorraghica, Crohn's disease, bowel obstruction, stomach/duodenal ulceration
- glucose/galactose malabsorption
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- severe diarrhea or other gastrointestinal disorder, which might interfere with the ability to absorb oral medication
- pregnancy or breast-feeding
- female participant of childbearing potential unwilling to take efficient contraceptive measures for the duration of the study
- female participant without negative serum or urine pregnancy test
- psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study
- currently participating in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis: a Short-term, Prospective, Open-label, Efficacy and Safety Clinical Trial
This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.
Read the detailed description
Nephrolithiasis/urolithiasis is a prevalent (overall lifetime risk up to 13% in Western countries) and highly recurrent disease. Secondary hyperoxaluria is a key risk factor for the development of calcium oxalate stones, the most frequent stone type. Currently used therapeutic options in secondary hyperoxaluria have limited efficacy. Recent findings in vitro and in a rat model, provided evidence that Lanthanum Carbonate is an effective oxalate binder. The objective of this study is to investigate whether treatment with Lanthanum Carbonate reduces urinary oxalate excretion in human subjects with secondary hyperoxaluria and nephrolithiasis. By treating the patients with two different doses of Lanthanum Carbonate during two 14-day treatment periods, a dose-response will be evaluated.
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis
- Being tested
- Lanthanum Carbonate
- Keywords
- Nephrolithiasis, Urolithiasis, Secondary Hyperoxaluria, Hyperoxaluria, Lanthanum Carbonate, Phosphate Binder
- Medical subject headings
- Nephrolithiasis, Urolithiasis, Hyperoxaluria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanthanum CarbonateDrug
Treatment with Lanthanum Carbonate 3 x 250 mg/day with meals during a first 14-day treatment period. Subsequently, treatment with Lanthanum Carbonate 3 x 500 mg/day with meals during a second 14-day treatment period
| Study group | Role | What they receive |
|---|---|---|
| Experimental single arm | Experimental | Treatment with Lanthanum Carbonate 3 x 250 mg/day with meals during a first 14-day treatment period. Subsequently, treatment with Lanthanum Carbonate 3 x 500 mg/day with meals during a second 14-day treatment period. Receives: Drug: Lanthanum Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg
Mean reduction in urinary oxalate excretion after the first 14-day treatment period during which patients will be treated with 250 mg Lanthanum Carbonate 3x/day with meals, expressed in mg oxalate/g creatinine.
Measured: After the first 14-day treatment period
Secondary outcomes (11)
The incremental reduction in mean urinary oxalate excretion after doubling the dose of Lanthanum Carbonate from 750 mg tot 1500 mg daily
Incremental reduction of mean urinary oxalate excretion after the second 14-day treatment period during which the patients will be treated with 500 mg Lanthanum Carbonate 3x/day with meals, expressed in mg oxalate/g creatinine
Measured: After the second 14-day treatment period
The proportion of patients developing severe hypophosphatemia
Severe hypophosphatemia is defined as serum phosphorus < 0.64 mmol/L
Measured: After the first and second 14-day treatment period
The evolution of phosphaturia, evaluated by 24-hour urinary phosphorus excretion
24-hour urinary phosphorus excretion will be expressed in mmol/24 hours
Measured: After the first and second 14-day treatment period
The evolution of phosphaturia, evaluated by urinary phosphorus to creatinine ratio
Urinary phosphorus to creatinine ratio will be expressed in mmol phosphorus/g creatinine
Measured: After the first and second 14-day treatment period
The evolution of phosphaturia, evaluated by fractional excretion of phosphorus
Fractional excretion of phosphorus will be expressed in %, defined as (urinary phosphorus (mmol/L) x serum creatinine (mg/dL) / (serum phosphorus (mmol/L) x urine creatinine (mg/dL))
Measured: After the first and second 14-day treatment period
The proportion of patients developing hypophosphaturia
Hypophosphaturia is defined as urinary phosphorus < 12.9 mmol/24 hours
Measured: After the first and second 14-day treatment period
The evolution of calciuria, evaluated by 24-hour urinary calcium excretion
24-hour urinary calcium excretion will be expressed in mmol/24 hours
Measured: After the first and second 14-day treatment period
The evolution of calciuria, evaluated by urinary calcium to creatinine ratio
Urinary calcium to creatinine ratio will be expressed in mmol calcium/g creatinine
Measured: After the first and second 14-day treatment period
The evolution of calciuria, evaluated by fractional excretion of calcium
Fractional excretion of calcium will be expressed in %, defined as (urinary calcium (mmol/L) x serum creatinine (mg/dL)) / (serum calcium (mmol/L) x urine creatinine (mg/dL))
Measured: After the first and second 14-day treatment period
The evolution of serum Lanthanum levels
Serum Lanthanum levels will be expressed in mcg/L
Measured: After the first and second 14-day treatment period
Adverse events
The number and the proportion of patients experiencing adverse events
Measured: After the first and second 14-day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start18 Aug 2017
- Primary completion10 Aug 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperoxaluriaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis. Patients will be treated during 2 consecutive 14-day treatment periods with a low and a high dose of Lanthanum Carbonate respectively.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Tielemans, MD, PhD, Principal investigator, Department of Nephrology, University Hospital Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346369
- Sponsor's protocol ID
- oxalate01
- Acronym
- LaCa
- Status last verified
- Aug 2026
- First submitted
- 28 Mar 2017
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis: a Short-term, Prospective, Open-label, Efficacy and Safety Clinical Trial
- ClinicalTrials.gov ID
- NCT03346369
- Acronym / sponsor ID
- LaCa / oxalate01
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis
- Keywords
- Nephrolithiasis, Urolithiasis, Secondary Hyperoxaluria, Hyperoxaluria, Lanthanum Carbonate, Phosphate Binder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 18 Aug 2017 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.
Detailed description
Nephrolithiasis/urolithiasis is a prevalent (overall lifetime risk up to 13% in Western countries) and highly recurrent disease. Secondary hyperoxaluria is a key risk factor for the development of calcium oxalate stones, the most frequent stone type. Currently used therapeutic options in secondary hyperoxaluria have limited efficacy. Recent findings in vitro and in a rat model, provided evidence that Lanthanum Carbonate is an effective oxalate binder. The objective of this study is to investigate whether treatment with Lanthanum Carbonate reduces urinary oxalate excretion in human subjects with secondary hyperoxaluria and nephrolithiasis. By treating the patients with two different doses of Lanthanum Carbonate during two 14-day treatment periods, a dose-response will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study investigates the efficacy and the safety of Lanthanum Carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis. Patients will be treated during 2 consecutive 14-day treatment periods with a low and a high dose of Lanthanum Carbonate respectively.
| Arm | Type | Receives |
|---|---|---|
| Experimental single arm | Experimental | Drug: Lanthanum CarbonateTreatment with Lanthanum Carbonate 3 x 250 mg/day with meals during a first 14-day treatment period. Subsequently, treatment with Lanthanum Carbonate 3 x 500 mg/day with meals during a second 14-day treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to give written informed consenct
- hyperoxaluria (defined as urinary oxalate > 45 mg/24 hours), demonstrated on 24-hour urine collection within 18 months prior to baseline visit
- history of nephrolithiasis eGFR > 60 mL/min/1.73m² (CKD-EPI formula)
Key exclusion criteria (12 listed)
- primary hyperoxaluria, diagnosed by genetic testing
- known allergy to Lanthanum Carbonate
- hypophosphatemia (defined as serum phosphorus < 0.81 mmol/L)
- severe known liver insufficiency of biliary obstruction
- rectocolitis ulcerohaemorraghica, Crohn's disease, bowel obstruction, stomach/duodenal ulceration
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 CarbonateTreatment with Lanthanum Carbonate 3 x 250 mg/day with meals during a first 14-day treatment period. Subsequently, treatment with Lanthanum Carbonate 3 x 500 mg/day with meals during a second 14-day treatment period | Drug | Experimental single arm |
Primary outcome
The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg
Time frame: After the first 14-day treatment period
Mean reduction in urinary oxalate excretion after the first 14-day treatment period during which patients will be treated with 250 mg Lanthanum Carbonate 3x/day with meals, expressed in mg oxalate/g creatinine.
11 secondary outcomes
The incremental reduction in mean urinary oxalate excretion after doubling the dose of Lanthanum Carbonate from 750 mg tot 1500 mg daily
Time frame: After the second 14-day treatment period
The proportion of patients developing severe hypophosphatemia
Time frame: After the first and second 14-day treatment period
The evolution of phosphaturia, evaluated by 24-hour urinary phosphorus excretion
Time frame: After the first and second 14-day treatment period
The evolution of phosphaturia, evaluated by urinary phosphorus to creatinine ratio
Time frame: After the first and second 14-day treatment period
The evolution of phosphaturia, evaluated by fractional excretion of phosphorus
Time frame: After the first and second 14-day treatment period
The proportion of patients developing hypophosphaturia
Time frame: After the first and second 14-day treatment period
The evolution of calciuria, evaluated by 24-hour urinary calcium excretion
Time frame: After the first and second 14-day treatment period
The evolution of calciuria, evaluated by urinary calcium to creatinine ratio
Time frame: After the first and second 14-day treatment period
The evolution of calciuria, evaluated by fractional excretion of calcium
Time frame: After the first and second 14-day treatment period
The evolution of serum Lanthanum levels
Time frame: After the first and second 14-day treatment period
Adverse events
Time frame: After the first and second 14-day treatment period
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 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Christian Tielemans, MD, PhD principal investigator
Department of Nephrology, University Hospital Brussels
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 in people with Secondary Hyperoxaluria and Nephrolithiasis, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 3 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: finished, as of the sponsor's last update on 10 Aug 2026. 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 Belgium. 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?
The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg (time frame: After the first 14-day treatment period). 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 10 Aug 2026.