- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03346369
Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis (LaCa)
January 7, 2021 updated by: Universitair Ziekenhuis Brussel
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
35
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Celine Olbrechts, Study Coordinator
- Phone Number: +32 (0)2 477 62 24
- Email: Celine.Olbrechts@uzbrussel.be
Study Locations
-
-
-
Brussels, Belgium, 1090
- Recruiting
- University Hospital Brussels
-
Contact:
- Els Van de Perre, MD
- Phone Number: +32 (2) 477 60 55
-
Contact:
- Celine Olbrechts
- Phone Number: +32 (2) 477 62 24
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
After the first 14-day treatment period
|
Secondary Outcome Measures
Outcome Measure |
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
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
|
After the second 14-day treatment period
|
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
|
After the first and second 14-day treatment period
|
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
|
After the first and second 14-day treatment period
|
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
|
After the first and second 14-day treatment period
|
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))
|
After the first and second 14-day treatment period
|
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
|
After the first and second 14-day treatment period
|
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
|
After the first and second 14-day treatment period
|
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
|
After the first and second 14-day treatment period
|
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))
|
After the first and second 14-day treatment period
|
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
|
After the first and second 14-day treatment period
|
Adverse events
Time Frame: After the first and second 14-day treatment period
|
The number and the proportion of patients experiencing adverse events
|
After the first and second 14-day treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Tielemans, MD, PhD, Department of Nephrology, University Hospital Brussels
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2017
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
March 28, 2017
First Submitted That Met QC Criteria
November 14, 2017
First Posted (Actual)
November 17, 2017
Study Record Updates
Last Update Posted (Actual)
January 8, 2021
Last Update Submitted That Met QC Criteria
January 7, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- oxalate01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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