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NCT00150540 Clinical Trial

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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00150540
Other study ID # SPD405-309
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 14, 2002
Est. completion date June 29, 2005

Study information
Verified date June 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date June 29, 2005
Est. primary completion date June 29, 2005
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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an effective contraceptive method while on study treatment and for 30 days thereafter Exclusion Criteria: - Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization - Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication - Pregnant or lactating women

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lanthanum carbonate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shire

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment emergent adverse events Up to 24 months
Secondary Changes in pre-dialysis serum phosphate levels Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Secondary Control of pre-dialysis serum phosphate levels Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Secondary Plasma lanthanum levels Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
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