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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental single arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum Carbonate | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After the first 14-day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After the second 14-day treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celine Olbrechts, Study Coordinator | Contact | +32 (0)2 477 62 24 | Celine.Olbrechts@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Christian Tielemans, MD, PhD | Department of Nephrology, University Hospital Brussels | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brussels | Recruiting | Brussels | 1090 | Belgium |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| D006959 | Hyperoxaluria |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
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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. Patients will be treated during 2 consecutive 14-day treatment periods with a low and a high dose of Lanthanum Carbonate respectively.
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| The proportion of patients developing severe hypophosphatemia | Severe hypophosphatemia is defined as serum phosphorus < 0.64 mmol/L | 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 | 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 | 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)) | After the first and second 14-day treatment period |
| The proportion of patients developing hypophosphaturia | Hypophosphaturia is defined as urinary phosphorus < 12.9 mmol/24 hours | After the first and second 14-day treatment period |
| The evolution of calciuria, evaluated by 24-hour urinary calcium excretion | 24-hour urinary calcium excretion will be expressed in mmol/24 hours | After the first and second 14-day treatment period |
| The evolution of calciuria, evaluated by urinary calcium to creatinine ratio | Urinary calcium to creatinine ratio will be expressed in mmol calcium/g creatinine | After the first and second 14-day treatment period |
| The evolution of calciuria, evaluated by fractional excretion of calcium | Fractional excretion of calcium will be expressed in %, defined as (urinary calcium (mmol/L) x serum creatinine (mg/dL)) / (serum calcium (mmol/L) x urine creatinine (mg/dL)) | After the first and second 14-day treatment period |
| The evolution of serum Lanthanum levels | Serum Lanthanum levels will be expressed in mcg/L | After the first and second 14-day treatment period |
| Adverse events | The number and the proportion of patients experiencing adverse events | After the first and second 14-day treatment period |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |