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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01518387
First received: January 18, 2012
Last updated: January 25, 2012
Last verified: January 2012
History of Changes

January 18, 2012
January 25, 2012
February 2006
July 2006   (final data collection date for primary outcome measure)
Change from baseline in serum phosphate levels at the end of the treatment period [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01518387 on ClinicalTrials.gov Archive Site
  • Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Serum calcium level corrected by serum albumin level at the end of the treatment period [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Serum calcium x phosphate product at the end of the treatment period [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Serum intact-PTH (Parathyroid) levels at the end of the treatment period [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
 
 
Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)

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.
 
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hyperphosphatemia
Drug: Lanthanum Carbonate (BAY77-1931)
Experimental: Arm 1
750-2250mg/day, tid, 8 weeks
Intervention: Drug: Lanthanum Carbonate (BAY77-1931)
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01518387
11878
No
Head Medical Development Japan, Bayer Yakuhin Ltd.
Bayer
 
Study Director: Bayer Study Director Bayer
Bayer
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP