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Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

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ClinicalTrials.gov Identifier: NCT01518387
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Hyperphosphatemia Drug: Lanthanum Carbonate (BAY77-1931) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : January 2006
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
750-2250mg/day, tid, 8 weeks
Drug: Lanthanum Carbonate (BAY77-1931)



Primary Outcome Measures :
  1. Change from baseline in serum phosphate levels at the end of the treatment period [ Time Frame: Baseline to Week 8 ]

Secondary Outcome Measures :
  1. Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement [ Time Frame: Week 8 ]
  2. Serum calcium level corrected by serum albumin level at the end of the treatment period [ Time Frame: Week 8 ]
  3. Serum calcium x phosphate product at the end of the treatment period [ Time Frame: Week 8 ]
  4. Serum intact-PTH (Parathyroid) levels at the end of the treatment period [ Time Frame: Week 8 ]
  5. Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01518387     History of Changes
Other Study ID Numbers: 11878
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016

Keywords provided by Bayer:
Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases