A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.
Status and phase
Completed
Phase 3
Conditions
Kidney Failure, Chronic
Treatments
Drug: Lanthanum carbonate
Details and patient eligibility
About
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.
Sex
All
Volunteers
No Healthy Volunteers
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- Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
- Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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