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NCT00151931 Clinical Trial

Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis

Kidney Failure, Chronic Clinical Trial

Official title:
A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00151931
Other study ID # SPD405-313
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 11, 2004
Est. completion date January 12, 2006

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 phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate

Recruitment information / eligibility
Status Completed
Enrollment 456
Est. completion date January 12, 2006
Est. primary completion date January 12, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males and females of childbearing potential agree to take adequate precautions to prevent contraception - Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study - Patient requires treatment for hyperphosphataemia Exclusion Criteria: - Pregnant or lactating women - Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium - Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma - Patients who are HIV+ - Patients with any significant gastrointestinal surgery or disorders

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lanthanum carbonate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shire

References & Publications (1)

Hutchison AJ, Laville M; SPD405-313 Lanthanum Study Group. Switching to lanthanum carbonate monotherapy provides effective phosphate control with a low tablet burden. Nephrol Dial Transplant. 2008 Nov;23(11):3677-84. doi: 10.1093/ndt/gfn310. Epub 2008 Jun 24. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5 Week 3 and Week 5
Secondary Treatment emergent adverse events Throughout the study period of approximately 20 months.
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