Does Lanthanum Carbonate reduce urinary oxalate output ?

Phase 1

• Conditions: rolithiasis and secondary hyperoxaluria; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2014-000308-82-BE
• Lead Sponsor: niversitair Ziekenhuis Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Last Update Posted: 28 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients aged 18 years or older
Willing to give Informed Consent
eGFR > 60 ml/min/1m²73 (CKD-EPI Formula)
Hyperoxaluaria (defined as urinary oxalate > 45 mg/24 hours), demonstrated on 24-hour urine collection within 18 months prior to baseline visit
History of nephrolithiasis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Allergy to Lanthanum Carbonate
Hypophosphateamia at baseline (< 0.81 mmol/L)
Severe known liver insufficiency
Pregnancy
Breast feeding
Female participant of childbearing potential unwilling to take efficient contraceptive measures for the duration of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified