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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitair Ziekenhuis Brussel

Criteria

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