A Phase 3 interventional study of Lanthanum Carbonate in Secondary Hyperoxaluria and Nephrolithiasis, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Universitair Ziekenhuis Brussel · Phase 3, Interventional, and Treatment
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.
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.
324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.
This study's enrollment of 54 is below the median of 92 across 257 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →Universitair Ziekenhuis Brussel is the lead sponsor of 375 studies on the registry; 107 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Lanthanum Carbonate
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
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.
Time frame: After the first 14-day treatment period
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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))
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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))
Time frame: After the first and second 14-day treatment period
The evolution of serum Lanthanum levels
Serum Lanthanum levels will be expressed in mcg/L
Time frame: After the first and second 14-day treatment period
Adverse events
The number and the proportion of patients experiencing adverse events
Time frame: After the first and second 14-day treatment period
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Aug 2024, 83 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lanthanum carbonate
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