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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00769496
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : January 23, 2013
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Brief Summary:
A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Drug: BAY 77-1931 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
Experimental: Arm 1 Drug: BAY 77-1931
Lanthanum Carbonate (BAY 77-1931)

Primary Outcome Measures :
  1. Changes in pre-dialysis serum phosphate levels [ Time Frame: Every 4 weeks ]

Secondary Outcome Measures :
  1. Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL) [ Time Frame: Every 4 weeks ]
  2. Changes in corrected serum calcium level [ Time Frame: Every 4 weeks ]
  3. Changes in the product of serum calcium and phosphate [ Time Frame: Every 4 weeks ]
  4. Changes in serum intact-PHT levels [ Time Frame: Every 4 weeks ]
  5. Changes in bone metabolism markers [ Time Frame: Every 4 weeks ]

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00769496

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, 780-8040
Kochi, Japan, 781-5103
Okayama, Japan, 701-0202
Tokushima, Japan, 770-0011
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Yakuhin Ltd. Identifier: NCT00769496     History of Changes
Other Study ID Numbers: 11551
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Phosphorus Metabolism Disorders
Metabolic Diseases