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
  Purpose

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.


Condition Intervention Phase
Hyperphosphatemia
Drug: Lanthanum Carbonate (BAY77-1931)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: February 2006
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
750-2250mg/day, tid, 8 weeks
Drug: Lanthanum Carbonate (BAY77-1931)

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518387

Locations
Japan
Asahikawa, Hokkaido, Japan, 070-0030
Kamakura, Kanagawa, Japan, 247-0072
Yokosuka, Kanagawa, Japan, 238-0011
Osaki, Miyagi, Japan, 989-6117
Sendai, Miyagi, Japan, 981-0912
Meguro-ku, Tokyo, Japan, 153-0061
Fukuoka, Japan, 815-0082
Gifu, Japan, 500-8717
Hiroshima, Japan, 730-8655
Okayama, Japan, 700-0013
Tokushima, Japan, 770-0011
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT01518387     History of Changes
Other Study ID Numbers: 11878
Study First Received: January 18, 2012
Last Updated: January 25, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014