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Long-Term Treatment on Bay 77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone
This study has been completed.
Sponsored by: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00767637
  Purpose

To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis


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

Drug Information available for: Lanthanum Carbonate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Open Label, Non-Controlled Long-Term Treatment on BAY 77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Changes in pre-dialysis serum phosphate levels [ Time Frame: Every 2 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 2 weeks ] [ Designated as safety issue: Yes ]
  • Changes in corrected serum calcium level [ Time Frame: Every 2 weeks ] [ Designated as safety issue: Yes ]
  • Changes in the product of serum calcium and phosphate [ Time Frame: Every 2 weeks ] [ Designated as safety issue: Yes ]
  • Changes in serum intact-PHT levels [ Time Frame: Every 2 weeks ] [ Designated as safety issue: Yes ]
  • Changes in bone metabolism markers [ Time Frame: Every 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: June 2005
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental Drug: Lanthanum Carbonate (BAY77-1931)
BAY 77-1931 750mg, in the morning, day and evening

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication

Exclusion Criteria:

  • Patients with severe hypocalcemia (adjusted serum calcium level of <7.5 mg/dL)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767637

Locations
Japan, Gunma
Isesaki, Gunma, Japan, 379-2211
Japan, Tottori
Yonago, Tottori, Japan, 683-0002
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

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Responsible Party: Bayer Yakuhin LTD ( Therapeutic Area Head )
Study ID Numbers: 11810, Fosrenol
Study First Received: October 6, 2008
Last Updated: December 3, 2008
ClinicalTrials.gov Identifier: NCT00767637  
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:
Metabolic Diseases
Hyperphosphatemia
Metabolic disorder

Additional relevant MeSH terms:
Phosphorus Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009



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