Status:
UNKNOWN
Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Secondary Hyperoxaluria
Nephrolithiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
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 cal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03346369
Start Date
August 18 2017
End Date
December 31 2022
Last Update
January 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Brussels
Brussels, Belgium, 1090