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

Universitair Ziekenhuis Brussel35 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperoxaluria Nephrolithiasis

Interventions

Lanthanum CarbonateDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Brussels

Brussels, Belgium

RECRUITING

Outcomes

Primary Outcomes

The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg

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.

Time frame: After the first 14-day treatment period

Secondary Outcomes

The incremental reduction in mean urinary oxalate excretion after doubling the dose of Lanthanum Carbonate from 750 mg tot 1500 mg daily

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

Time frame: After the second 14-day treatment period

The proportion of patients developing severe hypophosphatemia

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

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

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

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

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

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

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

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

The evolution of phosphaturia, evaluated by fractional excretion of phosphorus

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))

Central Contacts

Celine Olbrechts, Study Coordinator

CONTACT

+32 (0)2 477 62 24 Celine.Olbrechts@uzbrussel.be

Data from ClinicalTrials.gov

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