Dilanthanum tricarbonate

Health surveillance data

Administrative data

Endpoint:

health surveillance data

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference

Reference Type:

publication

Title:

Long-Term Efficacy and Tolerability of Lanthanum Carbonate: Results from a 3-Year Study

Author:

Hutchison, A. J. et al.

Year:

2006

Bibliographic source:

Nephron Clin Pract 102: c61-c71

Materials and methods

Study type:

human medical data

Endpoint addressed:

repeated dose toxicity: oral

Principles of method if other than guideline:

Six months and 2-year extensions to a 6-month study evaluated the long-term safety, tolerability and efficacy of the phophate binder lanthanum carbonate.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Dilanthanum tricarbonate

EC Number:

209-599-5

EC Name:

Dilanthanum tricarbonate

Cas Number:

587-26-8

Molecular formula:

La2(CO3)3

IUPAC Name:

dilanthanum tricarbonate

Details on test material:

- Name of test material (as cited in study report): lanthanum carbonate
- Analytical purity: no data

Method

Details on study design:

This open-label extension to the previous 6-month comparator-controlled trial consisted of two parts. The first part was a 6-month extension carried out at 67 centers in the UK, Germany and Belgium, and the Netherlands.
The second was a 2-year extension carried out at 34 of these centers in the UK, Germany and Belgium, and was initiated at the request of investigators and patients who participated in the previous phases of the study.
The design of the original comparator-controlled trial has been reported in [Hutchison 2005, Nephron Clin Pract 100: c8-c19].

Results and discussion

Results:

Mean serum phosphate was ~1.80 mmol/L throughout the trial. The percentage of patients with controlled serum phosphate (<= 1.80 mmol/L) after the 6-month extension was 63.3 and 58.4% in the continued-lanthanum and switch groups, respectively; after the 2-year extension, 54.4% of patientshad controlled serum phosphate. After discontinuation of calcium carbonate and initiation of lanthanum carbonate, the hypercalcemia incidence was 2.7%, compared with 20.2% during the double-blind phase. Calcium phosphate product was maintained at an acceptable level. Lanthanum carbonate was well tolerated; adverse events were mild and mainly gastrointestinal.
Importantly, there was no evidence of an increase in the frequency of adverse events previously associated with traditional phosphate-binder treatment, such as hypercalcemia, microcytic anemia, fractures or bone pain. The fact that 46 patients (the long-term-exposure group) were able to continue receiving lanthanum carbonate treatment with no unexpected adverse events anticipated in the long-term.

Applicant's summary and conclusion

Conclusions:

Lanthanum carbonate maintains effectiveness with continued tolerability for up to 3 years.