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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 (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01518387
First received: January 18, 2012
Last updated: March 10, 2016
Last verified: March 2016
January 18, 2012
March 10, 2016
January 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 ]
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 ]
  • Serum calcium level corrected by serum albumin level at the end of the treatment period [ Time Frame: Week 8 ]
  • Serum calcium x phosphate product at the end of the treatment period [ Time Frame: Week 8 ]
  • Serum intact-PTH (Parathyroid) levels at the end of the treatment period [ Time Frame: Week 8 ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (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)
Not Provided

*   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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01518387
11878
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
March 2016

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