A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.
Phase 3
Completed
- Conditions
- Kidney Failure, Chronic
- Registration Number
- NCT00150540
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
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- Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
- Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Treatment emergent adverse events Up to 24 months
- Secondary Outcome Measures
Name Time Method Plasma lanthanum levels Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24. Changes in pre-dialysis serum phosphate levels Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24. Control of pre-dialysis serum phosphate levels Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.