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

Primary Purpose

Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Lanthanum Carbonate (BAY77-1931)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

750-2250mg/day, tid, 8 weeks

Outcomes

Primary Outcome Measures

Change from baseline in serum phosphate levels at the end of the treatment period

Secondary Outcome Measures

Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement
Serum calcium level corrected by serum albumin level at the end of the treatment period
Serum calcium x phosphate product at the end of the treatment period
Serum intact-PTH (Parathyroid) levels at the end of the treatment period
Safety variables will be summarized using descriptive statistics based on adverse events collection

Full Information

First Posted
January 18, 2012
Last Updated
March 10, 2016
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT01518387
Brief Title
Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
Official Title
Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
Keywords
Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
750-2250mg/day, tid, 8 weeks
Intervention Type
Drug
Intervention Name(s)
Lanthanum Carbonate (BAY77-1931)
Primary Outcome Measure Information:
Title
Change from baseline in serum phosphate levels at the end of the treatment period
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement
Time Frame
Week 8
Title
Serum calcium level corrected by serum albumin level at the end of the treatment period
Time Frame
Week 8
Title
Serum calcium x phosphate product at the end of the treatment period
Time Frame
Week 8
Title
Serum intact-PTH (Parathyroid) levels at the end of the treatment period
Time Frame
Week 8
Title
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-0030
Country
Japan
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-0072
Country
Japan
City
Yokosuka
State/Province
Kanagawa
ZIP/Postal Code
238-0011
Country
Japan
City
Osaki
State/Province
Miyagi
ZIP/Postal Code
989-6117
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
981-0912
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-0061
Country
Japan
City
Fukuoka
ZIP/Postal Code
815-0082
Country
Japan
City
Gifu
ZIP/Postal Code
500-8717
Country
Japan
City
Hiroshima
ZIP/Postal Code
730-8655
Country
Japan
City
Okayama
ZIP/Postal Code
700-0013
Country
Japan
City
Tokushima
ZIP/Postal Code
770-0011
Country
Japan

12. IPD Sharing Statement

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

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