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

NCT03346369 | Unknown Phase 3

• 1 other identifier: oxalate01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Hyperoxaluria; Nephrolithiasis

Keywords

Nephrolithiasis; Urolithiasis; Secondary Hyperoxaluria; Hyperoxaluria; Lanthanum Carbonate; Phosphate Binder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

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

  After the second 14-day treatment period

• The proportion of patients developing severe hypophosphatemia

  After the first and second 14-day treatment period

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

  After the first and second 14-day treatment period

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

  After the first and second 14-day treatment period

• The evolution of phosphaturia, evaluated by fractional excretion of phosphorus

  After the first and second 14-day treatment period

Study Arms (1)

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.

Drug: Lanthanum Carbonate

Interventions

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

Experimental single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

University Hospital Brussels

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis; Urolithiasis; Hyperoxaluria

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Christian Tielemans, MD, PhD

  Department of Nephrology, University Hospital Brussels

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Olbrechts, Study Coordinator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: November 17, 2017
• Study Start: August 18, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)