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Completed

NCT Number: NCT03346369

Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis

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.

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Key information

Conditions

Secondary Hyperoxaluria Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperoxaluria Kidney Diseases Male Urogenital Diseases Nephrolithiasis Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Brussels

Brussels, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Lanthanum carbonate

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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

  2. The proportion of patients developing severe hypophosphatemia

    Time frame: After the first and second 14-day treatment period

    Severe hypophosphatemia is defined as serum phosphorus < 0.64 mmol/L

  3. The evolution of phosphaturia, evaluated by 24-hour urinary phosphorus excretion

    Time frame: After the first and second 14-day treatment period

    24-hour urinary phosphorus excretion will be expressed in mmol/24 hours

  4. The evolution of phosphaturia, evaluated by urinary phosphorus to creatinine ratio

    Time frame: After the first and second 14-day treatment period

    Urinary phosphorus to creatinine ratio will be expressed in mmol phosphorus/g creatinine

  5. The evolution of phosphaturia, evaluated by fractional excretion of phosphorus

    Time frame: After the first and second 14-day treatment period

    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))

  6. The proportion of patients developing hypophosphaturia

    Time frame: After the first and second 14-day treatment period

    Hypophosphaturia is defined as urinary phosphorus < 12.9 mmol/24 hours

  7. The evolution of calciuria, evaluated by 24-hour urinary calcium excretion

    Time frame: After the first and second 14-day treatment period

    24-hour urinary calcium excretion will be expressed in mmol/24 hours

  8. The evolution of calciuria, evaluated by urinary calcium to creatinine ratio

    Time frame: After the first and second 14-day treatment period

    Urinary calcium to creatinine ratio will be expressed in mmol calcium/g creatinine

  9. The evolution of calciuria, evaluated by fractional excretion of calcium

    Time frame: After the first and second 14-day treatment period

    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))

  10. The evolution of serum Lanthanum levels

    Time frame: After the first and second 14-day treatment period

    Serum Lanthanum levels will be expressed in mcg/L

  11. Adverse events

    Time frame: After the first and second 14-day treatment period

    The number and the proportion of patients experiencing adverse events

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study 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

Acronym: LaCa

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Nov 17, 2017
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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