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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014