Status:
COMPLETED
A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.
Lead Sponsor:
Shire
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
- Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication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
Key Trial Info
Start Date :
October 14 2002
Trial Type :
INTERVENTIONAL
End Date :
June 29 2005
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00150540
Start Date
October 14 2002
End Date
June 29 2005
Last Update
June 23 2021
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