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

Phase 2

Completed

• Conditions: Hyperphosphatemia; Dialysis
• Interventions: Drug: Lanthanum Carbonate (BAY77-1931)

• Registration Number: NCT00767637
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-19
• Last Update Posted: 2014-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication

Read More

Exclusion Criteria

• Patients with severe hypocalcemia (adjusted serum calcium level of <7.5 mg/dL)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Lanthanum Carbonate (BAY77-1931)	-

Primary Outcome Measures

Name	Time	Method
Changes in pre-dialysis serum phosphate levels	Every 2 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in corrected serum calcium level	Every 2 weeks
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)	Every 2 weeks
Changes in the product of serum calcium and phosphate	Every 2 weeks
Changes in serum intact-PHT levels	Every 2 weeks
Changes in bone metabolism markers	Every 2 weeks