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

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ClinicalTrials.gov Identifier: NCT03346369
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Secondary Hyperoxaluria Nephrolithiasis Drug: Lanthanum Carbonate Phase 3

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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis: a Short-term, Prospective, Open-label, Efficacy and Safety Clinical Trial
Actual Study Start Date : August 18, 2017
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Experimental: Experimental single arm
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.
Drug: Lanthanum Carbonate
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




Primary Outcome Measures :
  1. The mean reduction in urinary oxalate excretion in patients treated with a daily Lanthanum Carbonate dose of 750 mg [ Time Frame: After the first 14-day treatment period ]
    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.


Secondary Outcome Measures :
  1. The incremental reduction in mean urinary oxalate excretion after doubling the dose of Lanthanum Carbonate from 750 mg tot 1500 mg daily [ Time Frame: After the second 14-day treatment period ]
    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

  2. The proportion of patients developing severe hypophosphatemia [ Time Frame: After the first and second 14-day treatment period ]
    Severe hypophosphatemia is defined as serum phosphorus < 0.64 mmol/L

  3. The evolution of phosphaturia, evaluated by 24-hour urinary phosphorus excretion [ Time Frame: After the first and second 14-day treatment period ]
    24-hour urinary phosphorus excretion will be expressed in mmol/24 hours

  4. The evolution of phosphaturia, evaluated by urinary phosphorus to creatinine ratio [ Time Frame: After the first and second 14-day treatment period ]
    Urinary phosphorus to creatinine ratio will be expressed in mmol phosphorus/g creatinine

  5. The evolution of phosphaturia, evaluated by fractional excretion of phosphorus [ Time Frame: After the first and second 14-day treatment period ]
    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))

  6. The proportion of patients developing hypophosphaturia [ Time Frame: After the first and second 14-day treatment period ]
    Hypophosphaturia is defined as urinary phosphorus < 12.9 mmol/24 hours

  7. The evolution of calciuria, evaluated by 24-hour urinary calcium excretion [ Time Frame: After the first and second 14-day treatment period ]
    24-hour urinary calcium excretion will be expressed in mmol/24 hours

  8. The evolution of calciuria, evaluated by urinary calcium to creatinine ratio [ Time Frame: After the first and second 14-day treatment period ]
    Urinary calcium to creatinine ratio will be expressed in mmol calcium/g creatinine

  9. The evolution of calciuria, evaluated by fractional excretion of calcium [ Time Frame: After the first and second 14-day treatment period ]
    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))

  10. The evolution of serum Lanthanum levels [ Time Frame: After the first and second 14-day treatment period ]
    Serum Lanthanum levels will be expressed in mcg/L

  11. Adverse events [ Time Frame: After the first and second 14-day treatment period ]
    The number and the proportion of patients experiencing adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346369


Contacts
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Contact: Celine Olbrechts, Study Coordinator +32 (0)2 477 62 24 Celine.Olbrechts@uzbrussel.be

Locations
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Belgium
University Hospital Brussels Recruiting
Brussels, Belgium, 1090
Contact: Els Van de Perre, MD    +32 (2) 477 60 55      
Contact: Celine Olbrechts    +32 (2) 477 62 24      
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Christian Tielemans, MD, PhD Department of Nephrology, University Hospital Brussels

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03346369     History of Changes
Other Study ID Numbers: oxalate01
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Universitair Ziekenhuis Brussel:
Nephrolithiasis
Urolithiasis
Secondary Hyperoxaluria
Hyperoxaluria
Lanthanum Carbonate
Phosphate Binder
Additional relevant MeSH terms:
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Neoplasm Metastasis
Nephrolithiasis
Kidney Calculi
Hyperoxaluria
Neoplastic Processes
Neoplasms
Pathologic Processes
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical