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

Hyperphosphatemia Clinical Trial

Official title:

Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518387
• Other study ID #: 11878
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2012
• Last updated: March 10, 2016
• Start date: January 2006
• Est. completion date: July 2006

Study information

• Verified date: March 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• Lanthanum Carbonate (BAY77-1931)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in serum phosphate levels at the end of the treatment period		Baseline to Week 8	No
Secondary	Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement		Week 8	No
Secondary	Serum calcium level corrected by serum albumin level at the end of the treatment period		Week 8	No
Secondary	Serum calcium x phosphate product at the end of the treatment period		Week 8	No
Secondary	Serum intact-PTH (Parathyroid) levels at the end of the treatment period		Week 8	No
Secondary	Safety variables will be summarized using descriptive statistics based on adverse events collection		8 weeks	Yes

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