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
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 April 14, 2014