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

Universitair Ziekenhuis Brussel

Status and phase: Unknown; Phase 3

Conditions: Secondary Hyperoxaluria; Nephrolithiasis

Treatments: Drug: Lanthanum Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT03346369

oxalate01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Experimental single arm

Experimental group

Description:

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.

Treatment:

Drug: Lanthanum Carbonate