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
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

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.

External Links

•   FDA Recall Information
•   FDA-approved Label