BAY 77-1931 Long-term Extension From Phase II Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00769496
First received: October 8, 2008
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis


Condition Intervention Phase
Hyperphosphatemia
Drug: BAY 77-1931
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term, Open Label Extension, Non-controlled Study to Assess the Efficacy and Safety of BAY 77-1931 (Lanthanum Carbonate) for Hyperphosphatemia in Patients Undergoing Hemodialysis

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Changes in pre-dialysis serum phosphate levels [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL) [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
  • Changes in corrected serum calcium level [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
  • Changes in the product of serum calcium and phosphate [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
  • Changes in serum intact-PHT levels [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
  • Changes in bone metabolism markers [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 145
Study Start Date: January 2005
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: BAY 77-1931
Lanthanum Carbonate (BAY 77-1931)

  Eligibility

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

Inclusion Criteria:

  • Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least

Exclusion Criteria:

  • Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period
  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: NCT00769496

Locations
Japan
Toyohashi, Aichi, Japan, 441-8023
Yatomi, Aichi, Japan, 498-0006
Kashiwa, Chiba, Japan, 277-0084
Narita, Chiba, Japan, 286-0041
Sakura, Chiba, Japan, 285-0846
Asahikawa, Hokkaido, Japan, 070-0030
Suita, Osaka, Japan, 564-0053
Chiba, Japan, 261-0011
Hiroshima, Japan, 730-0811
Kochi, Japan, 780-0066
Kochi, Japan, 781-5103
Kochi, Japan, 780-8040
Okayama, Japan, 701-0202
Tokushima, Japan, 770-0011
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT00769496     History of Changes
Other Study ID Numbers: 11551
Study First Received: October 8, 2008
Last Updated: January 21, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014