N/A
Completed N=66
Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy
Source: ClinicalTrials.gov NCT01130831 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy — 14.9 percentage of subjects
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy |
14.9 | — |
| PRIMARY Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Lanthanum Carbonate |
40.0 | — |
| SECONDARY Percent of Subjects That Achieved Controlled Serum Calcium Levels on Calcium-based Phosphate Binder Therapy |
68.1 | — |
| SECONDARY Percent of Subjects That Achieved Controlled Serum Calcium Levels on Lanthanum Carbonate Therapy |
52.5 | — |
| SECONDARY Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Calcium-based Phosphate Binder Therapy |
42.6 | — |
| SECONDARY Percent of Subjects That Achieved Controlled Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy |
75.0 | — |
| SECONDARY Percent of Subjects That Maintained Control of Serum Phosphorous Levels on Lanthanum Carbonate |
73.8; 7.1; 7.1; 11.9 | — |
| SECONDARY Percent of Subjects That Maintained Control of Serum Calcium Levels on Lanthanum Carbonate |
53.7; 22.0; 7.3; 17.1 | — |
| SECONDARY Percent of Subjects That Maintained Control of Serum Calcium-Phosphorous Product Levels on Lanthanum Carbonate Therapy |
47.5; 17.5; 5.0; 30.0 | — |
| SECONDARY Percent of Subjects That Maintained Control of Intact Parathyroid Hormone (iPTH) Levels on Lanthanum Carbonate Therapy |
81.6; 10.5; 2.6; 5.3 | — |
| SECONDARY Percent Change From Baseline in Phosphorous Levels at 12 Months |
-7.9 | — |
| SECONDARY Percent Change From Baseline in Calcium Levels at 12 Months |
-1.1 | — |
| SECONDARY Percent Change From Baseline in Calcium-Phosphorous Product Levels at 12 Months |
-8.7 | — |
| SECONDARY Percent Change From Baseline in iPTH Levels at 12 Months |
95.4 | — |
| SECONDARY Percent Change From Baseline in 25-Hydroxy Vitamin D Levels at 12 Months |
41.0 | — |
| SECONDARY Percent Change From Baseline in 1,25-Hydroxy Vitamin D Levels at 12 Months |
1.1 | — |
| SECONDARY Percent of Subjects With Hypocalcemic Events on Calcium-based Phosphate Binder Therapy |
10.6 | — |
| SECONDARY Percent of Subjects With Hypocalcemic Events on Lanthanum Carbonate |
22.5 | — |
| SECONDARY Percent of Subjects With Hypercalcemic Events on Calcium-based Phosphate Binder Therapy |
0.0 | — |
| SECONDARY Percent of Subjects With Hypercalcemic Events on Lanthanum Carbonate |
0.0 | — |
| SECONDARY Change From Baseline in Vitamin D Dose at 12 Months |
-0.7 | — |
| SECONDARY Change From Baseline in Mean Total Daily Dose of Calcium at 12 Months |
-178.6 | — |
| SECONDARY Number of Tablets Per Day |
3.4 | — |
Eligibility Criteria
Inclusion Criteria
Patients meeting all of the criteria listed below may be included in the study:
- Patients aged over 18 years
- Patients with ESRD on haemodialysis who are willing and able to provide written informed consent.
- 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.
- 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:
- Known or suspected intolerance or hypersensitivity to lanthanum, or any of the stated ingredients
- Patients with known hypophosphatemia (phosphate level below lower level of normal)
- Patients with severe hepatic impairment
- Patients with requirement for calcium supplementation for reasons other than CKD
- Pregnant or lactating women and women planning to become pregnant over the next 12 months
Data sourced from ClinicalTrials.gov (NCT01130831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.