Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy

Shire

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Drug: Lanthanum carbonate

Study type: Observational

Funder types: Industry

Identifiers

NCT01130831

SPD405-702

Details and patient eligibility

About

To assess the percentage of patients on lanthanum carbonate, that achieve Kidney Disease Outcome Quality Initiative (KDOQI) guideline suggested values for serum phosphorous in patients previously treated with calcium-based phosphate binder therapy.

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients meeting all of the criteria listed below may be included in the study:

1. Patients aged over 18 years

2. Patients with ESRD on haemodialysis who are willing and able to provide written informed consent.

3. Patients on:

   • Lanthanum carbonate monotherapy for ≥1 month
   • Lanthanum carbonate monotherapy for ≤3 months
   • Calcium-based monotherapy for ≥3 months immediately prior to lanthanum carbonate therapy.

4. Values recorded in medical records detailing serum phosphorous, serum calcium-phosphorus product, iPTH, and medication ≤6 months prior to commencing lanthanum carbonate therapy and whilst on a calcium-based monotherapy.

Exclusion criteria

Patients are excluded from the study if any of the following criteria are met at screening:

1. Known or suspected intolerance or hypersensitivity to lanthanum, or any of the stated ingredients
2. Patients with known hypophosphatemia (phosphate level below lower level of normal)
3. Patients with severe hepatic impairment
4. Patients with requirement for calcium supplementation for reasons other than CKD
5. Pregnant or lactating women and women planning to become pregnant over the next 12 months