Back to resultsEfficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
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 receiving haemodialysis for ESRD Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months Exclusion Criteria: Pregnant or lactating women Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma Patients who are HIV+ Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months
Sites / Locations
Outcomes
Primary Outcome Measures
Mean pre-dialysis serum phosphate level
Secondary Outcome Measures
Mean pre-dialysis serum calcium product
Mean pre-dialysis calcium-phosphate product
Average daily pill burden
Treatment emergent adverse events
Treatment-emergent adverse events (TEAEs) were defined as AEs that had an onset date and time on or after the date and time of the first dose of study medication.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00151918
Brief Title
Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
Official Title
A Multi-Centre, Open Label, Randomized, Parallel Group Pilot Study to Assess the Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2005 (Actual)
Primary Completion Date
August 22, 2005 (Actual)
Study Completion Date
August 22, 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 phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lanthanum carbonate
Primary Outcome Measure Information:
Title
Mean pre-dialysis serum phosphate level
Time Frame
The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Secondary Outcome Measure Information:
Title
Mean pre-dialysis serum calcium product
Time Frame
The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Title
Mean pre-dialysis calcium-phosphate product
Time Frame
The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Title
Average daily pill burden
Time Frame
Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.
Title
Treatment emergent adverse events
Description
Treatment-emergent adverse events (TEAEs) were defined as AEs that had an onset date and time on or after the date and time of the first dose of study medication.
Time Frame
Throughout the study period of approximately 7.5 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients receiving haemodialysis for ESRD
Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months
Exclusion Criteria:
Pregnant or lactating women
Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
Patients who are HIV+
Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months
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
Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
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