N/A
N=66
Effect of Lanthanum Carbonate in Patients Previously Treated With Calcium-based Phosphate Binder Therapy
End Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01130831 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Percent of Subjects That Achieved Controlled Serum Phosphorous Levels on Calcium-based Phosphate Binder Therapy — 14.9 percentage of subjects
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lanthanum carbonate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jun 2012
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 | — |
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.
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.