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Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperphosphatemia; Dialysis

Intervention: Lanthanum Carbonate (BAY77-1931) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis

Clinical Details

Official title: Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Changes in pre-dialysis serum phosphate levels

Secondary outcome:

Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)

Changes in corrected serum calcium level

Changes in the product of serum calcium and phosphate

Changes in serum intact-PHT levels

Changes in bone metabolism markers

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients undergoing dialysis or plan to start dialysis before the initial

administration of the study medication Exclusion Criteria:

- Patients with severe hypocalcemia (adjusted serum calcium level of <7. 5 mg/dL)

Locations and Contacts

Isesaki, Gunma 379-2211, Japan

Yonago, Tottori 683-0002, Japan

Additional Information

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Starting date: June 2005
Last updated: June 19, 2014

Page last updated: August 23, 2015

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