Back to resultsEfficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis
Primary Purpose
Kidney Failure, Chronic
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lanthanum carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5
Secondary Outcome Measures
Treatment emergent adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00151931
Brief Title
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2004 (Actual)
Primary Completion Date
January 12, 2006 (Actual)
Study Completion Date
January 12, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
456 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lanthanum carbonate
Primary Outcome Measure Information:
Title
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5
Time Frame
Week 3 and Week 5
Secondary Outcome Measure Information:
Title
Treatment emergent adverse events
Time Frame
Throughout the study period of approximately 20 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18577536
Citation
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.
Results Reference
background
Links:
URL
http://www.fda.gov/opacom/7alerts.html
Description
FDA Recall Information
Learn more about this trial
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis
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