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

Last updated: January 7, 2021
Sponsor: Universitair Ziekenhuis Brussel
Overall Status: Active - Recruiting

Phase

3

Condition

Neoplasm Metastasis

Kidney Stones

Treatment

N/A

Clinical Study ID

NCT03346369
oxalate01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • able to give written informed consenct
  • hyperoxaluria (defined as urinary oxalate > 45 mg/24 hours), demonstrated on 24-hoururine collection within 18 months prior to baseline visit
  • history of nephrolithiasis eGFR > 60 mL/min/1.73m² (CKD-EPI formula)

Exclusion

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/duodenalulceration
  • glucose/galactose malabsorption
  • severe diarrhea or other gastrointestinal disorder, which might interfere with theability to absorb oral medication
  • pregnancy or breast-feeding
  • female participant of childbearing potential unwilling to take efficient contraceptivemeasures 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 orability to understand the requirements of the study
  • currently participating in another clinical trial

Study Design

Total Participants: 35
Study Start date:
August 18, 2017
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • University Hospital Brussels

    Brussels, 1090
    Belgium

    Active - Recruiting

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