check_circleStudy Completed

Hyperphosphatemia

Bayer Identifier:

11878

ClinicalTrials.gov Identifier:

NCT01518387

EudraCT Number:

Not Available

EU CT Number:

Not Available
Open study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

20 - 75 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
43
Trial Dates
January 2006 - July 2006
Phase
Phase 3
Could I Receive a placebo
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kitasaito HospitalAsahikawa, 070-0030, Japan
Completed
Eijinkai HospitalOsaki, 989-6117, Japan
Completed
Sendai Shakaihoken HospitalSendai, 981-0912, Japan
Completed
Tokyo Kyosai HospitalMeguro-ku, 153-0061, Japan
Completed
Shonan Kamakura General HospitalKamakura, 247-0072, Japan
Completed
Yokosuka Kyosai HospitalYokosuka, 238-0011, Japan
Completed
Gifu Prefectural General Medical CenterGifu, 500-8717, Japan
Completed
Okayama Saiseikai General HospitalOkayama, 700-0013, Japan
Completed
Tsuchiya General HospitalHiroshima, 730-8655, Japan
Completed
Kawashima HospitalTokushima, 770-0011, Japan
Completed
Fukuoka Red Cross HospitalFukuoka, 815-0082, Japan

Primary Outcome

  • Change from baseline in serum phosphate levels at the end of the treatment period
    date_rangeTime Frame:
    Baseline to Week 8
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Serum calcium level corrected by serum albumin level at the end of the treatment period
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Serum calcium x phosphate product at the end of the treatment period
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Serum intact-PTH (Parathyroid) levels at the end of the treatment period
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Safety variables will be summarized using descriptive statistics based on adverse events collection
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Phase III open study of BAY 77 1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis (CAPD)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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