Back to resultsA Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.
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: 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use an effective contraceptive method while on study treatment and for 30 days thereafter Exclusion Criteria: Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication Pregnant or lactating women
Sites / Locations
Outcomes
Primary Outcome Measures
Treatment emergent adverse events
Secondary Outcome Measures
Changes in pre-dialysis serum phosphate levels
Control of pre-dialysis serum phosphate levels
Plasma lanthanum levels
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00150540
Brief Title
A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.
Official Title
A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 14, 2002 (Actual)
Primary Completion Date
June 29, 2005 (Actual)
Study Completion Date
June 29, 2005 (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 the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.
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
93 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lanthanum carbonate
Primary Outcome Measure Information:
Title
Treatment emergent adverse events
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Changes in pre-dialysis serum phosphate levels
Time Frame
Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Title
Control of pre-dialysis serum phosphate levels
Time Frame
Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
Title
Plasma lanthanum levels
Time Frame
Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.
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