A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.

A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150540

Enrollment

Registered

2005-09-08

Start date

2002-10-14

Completion date

2005-06-29

Last updated

2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Brief summary

The purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.

Interventions

DRUGLanthanum carbonate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients who participated in LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 and received lanthanum carbonate * Patients must continue to require treatment with a phosphate binder for hyperphosphatemia * male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter

Exclusion criteria

* Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization * Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed possible or related to study medication * Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Treatment emergent adverse events	Up to 24 months

Secondary

Measure	Time frame
Changes in pre-dialysis serum phosphate levels	Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Control of pre-dialysis serum phosphate levels	Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Plasma lanthanum levels	Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026