Does Lanthanum Carbonate reduce urinary oxalate output ?

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 - The effect of Lanthanum Carbonate on oxaluria.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000308-82-BE

Enrollment

Registered

2017-01-05

Start date

2017-02-08

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis and secondary hyperoxaluria

Interventions

Trade Name: Fosrenol Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: LANTHANUM CARBONATE HYDRATE CAS Number: 54451-24-0 Other descriptive name: LANTHANUM CARBONATE HYDRATE Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older Willing to give Informed Consent eGFR > 60 ml/min/1m²73 (CKD-EPI Formula) Hyperoxaluaria (defined as urinary oxalate > 45 mg/24 hours), demonstrated on 24-hour urine collection within 18 months prior to baseline visit History of nephrolithiasis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Allergy to Lanthanum Carbonate Hypophosphateamia at baseline (< 0.81 mmol/L) Severe known liver insufficiency Pregnancy Breast feeding Female participant of childbearing potential unwilling to take efficient contraceptive measures for the duration of the study

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective: to investigate whether the administration of Lanthanum Carbonate at a dose of 750 mg daily reduces the urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.;Secondary Objective: Secondary objectives - to investigate whether a dose increase from 750 to 1500 mg Lanthanum Carbonate daily results in a significant decrease in urinary oxalate excretion - to investigate the effect of Lanthanum Carbonate on serum phosphorus and urinary phosphorus excretion - to evaluate the effect of Lanthanum Carbonate on serum calcium and urinary calcium excretion - to assess the evolution of serum Lanthanum levels - to assess the safety of Lanthanum Carbonate ;Primary end point(s): The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg, expressed in mg/24 hours and as urinary oxalate to creatinine ratio, expressed in mg oxalate/g creatinine.;Timepoint(s) of evaluation of this end point: After first 2-week experimental period (between days 12 and 14)	—

Measure

Time frame

Main Objective: Primary objective: to investigate whether the administration of Lanthanum Carbonate at a dose of 750 mg daily reduces the urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.;Secondary Objective: Secondary objectives - to investigate whether a dose increase from 750 to 1500 mg Lanthanum Carbonate daily results in a significant decrease in urinary oxalate excretion - to investigate the effect of Lanthanum Carbonate on serum phosphorus and urinary phosphorus excretion - to evaluate the effect of Lanthanum Carbonate on serum calcium and urinary calcium excretion - to assess the evolution of serum Lanthanum levels - to assess the safety of Lanthanum Carbonate ;Primary end point(s): The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg, expressed in mg/24 hours and as urinary oxalate to creatinine ratio, expressed in mg oxalate/g creatinine.;Timepoint(s) of evaluation of this end point: After first 2-week experimental period (between days 12 and 14)

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Secondary

Measure	Time frame
Secondary end point(s): The incremental reduction in urinary oxalate excretion after doubling of the dose of Lanthanum Carbonate from 750 mg to 1500 mg daily, expressed in mg/24 hours and as urinary oxalate to creatinine ratio, expressed in mg oxalate/g creatinine The proportion of patients developing severe hypophosphatemia after the first and after the second treatment period, defined as serum phosphorus < 0.64 mmol/L The evolution of phosphaturia during the study, evaluated by - 24-hour urinary phosphorus excretion, expressed in mmol/24 hours - urinary phosphorus to creatinine ratio, expressed in mmol phosphorus/g creatinine - fractional excretion of phosphorus , expressed in %, defined as (urinary phosphorus (mmol/L) x serum creatinine (mg/dL)) / (serum phosphorus (mmol/L) x urine creatinine (mg/dL)) The proportion of patients developing hypophosphaturia after the first and after the second treatment period, defined as urinary phosphorus < 12.9 mmol/24 hours The evolution of calcemia during the study, expressed in mmol/L (with serum calcium corrected for the serum albumin concentration according to the formula: corrected calcium (mmol/L) = measured calcium (mmol/L) + 0.02 x (40 - albumin (g/L)) The evolution of calciuria during the study, evaluated by - 24-hour urinary calcium excretion, expressed in mmol/24 hours - urinary calcium to creatinine ratio, expressed in mmol calcium/g creatinine - fractional excretion of calcium, expressed in % defined as (urinary calcium (mmol/L) x serum creatinine (mg/dL)) / (serum calcium(mmol/L) x urine creatinine (mg/dL)), with serum calcium corrected for the serum albumin concentration according to the formula: corrected calcium (mmol/L) = measured calcium (mmol/L) + 0.02 x (40 - albumin (g/L)) The evolution of mean serum La levels, expressed in mcg/L The number and the proportion of patients experiencing adverse events ;Timepoint(s) of evaluation of this end point: After first 2-week treatment period (betw	—

Measure

Time frame

Secondary end point(s): The incremental reduction in urinary oxalate excretion after doubling of the dose of Lanthanum Carbonate from 750 mg to 1500 mg daily, expressed in mg/24 hours and as urinary oxalate to creatinine ratio, expressed in mg oxalate/g creatinine The proportion of patients developing severe hypophosphatemia after the first and after the second treatment period, defined as serum phosphorus < 0.64 mmol/L The evolution of phosphaturia during the study, evaluated by - 24-hour urinary phosphorus excretion, expressed in mmol/24 hours - urinary phosphorus to creatinine ratio, expressed in mmol phosphorus/g creatinine - fractional excretion of phosphorus , expressed in %, defined as (urinary phosphorus (mmol/L) x serum creatinine (mg/dL)) / (serum phosphorus (mmol/L) x urine creatinine (mg/dL)) The proportion of patients developing hypophosphaturia after the first and after the second treatment period, defined as urinary phosphorus < 12.9 mmol/24 hours The evolution of calcemia during the study, expressed in mmol/L (with serum calcium corrected for the serum albumin concentration according to the formula: corrected calcium (mmol/L) = measured calcium (mmol/L) + 0.02 x (40 - albumin (g/L)) The evolution of calciuria during the study, evaluated by - 24-hour urinary calcium excretion, expressed in mmol/24 hours - urinary calcium to creatinine ratio, expressed in mmol calcium/g creatinine - fractional excretion of calcium, expressed in % defined as (urinary calcium (mmol/L) x serum creatinine (mg/dL)) / (serum calcium(mmol/L) x urine creatinine (mg/dL)), with serum calcium corrected for the serum albumin concentration according to the formula: corrected calcium (mmol/L) = measured calcium (mmol/L) + 0.02 x (40 - albumin (g/L)) The evolution of mean serum La levels, expressed in mcg/L The number and the proportion of patients experiencing adverse events ;Timepoint(s) of evaluation of this end point: After first 2-week treatment period (betw

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Countries

Belgium

Contacts

Public ContactChristian TIELEMANS

Universitair Ziekenhuis Brussel

ctielema@uzbrussel.be3224776055

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026