Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

Phase 3

Completed

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

• Registration Number: NCT01518387
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-10
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period
• Out-patient
• Undergoing CAPD for at least previous 3 consecutive months

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Exclusion Criteria

• Who may not enable to continue CAPD
• Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
• Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
• Serum intact PTH (Parathyroid) of >=1000 pg/mL at the start of the washout period
• Pregnant woman, or lactating mother
• Significant gastrointestinal disorders including known acute peptic ulcer
• Liver dysfunction
• History of cardiovascular or cerebrovascular diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Lanthanum Carbonate (BAY77-1931)	750-2250mg/day, tid, 8 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum phosphate levels at the end of the treatment period	Baseline to Week 8

Secondary Outcome Measures

Name	Time	Method
Safety variables will be summarized using descriptive statistics based on adverse events collection	8 weeks
Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement	Week 8
Serum calcium x phosphate product at the end of the treatment period	Week 8
Serum calcium level corrected by serum albumin level at the end of the treatment period	Week 8
Serum intact-PTH (Parathyroid) levels at the end of the treatment period	Week 8