check_circleStudy Completed

Hyperphosphatemia

Bayer Identifier:

11551

ClinicalTrials.gov Identifier:

NCT00769496

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY 77-1931 Long-term Extension from Phase II Study

Trial purpose

A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis

Key Participants Requirements

Sex

Both

Age

20 - 75 Years
  • - Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least
  • - Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period

Trial summary

Enrollment Goal
145
Trial Dates
January 2005 - May 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Mihama HospitalChiba, 261-0011, Japan
Completed
Shin Kashiwa ClinicKashiwa, 277-0084, Japan
Completed
Ama Kyoritsu ClinicYatomi, 498-0006, Japan
Completed
Kawashima HospitalTokushima, 770-0011, Japan
Completed
Shimazu HospitalKochi, 780-0066, Japan
Completed
Kochi Takasu HospitalKochi, 781-5103, Japan
Completed
Kitasaito HospitalAsahikawa, 070-0030, Japan
Completed
Inoue HospitalSuita, 564-0053, Japan
Completed
Mihama Narita ClinicNarita, 286-0041, Japan
Completed
Mihama Shizu ClinicSakura, 285-0846, Japan
Completed
Meiyo ClinicToyohashi, 441-8023, Japan
Completed
Shigei Medical Research HospitalOkayama, 701-0202, Japan
Completed
Nakajima Tsuchiya ClinicHiroshima, 730-0811, Japan
Completed
Koseinenkin Kochi Rehabilitation HospitalKochi, 780-8040, Japan
Completed
Kawashima Cardiovascular ClinicTokushima, 770-0011, Japan

Primary Outcome

  • Changes in pre-dialysis serum phosphate levels
    date_rangeTime Frame:
    Every 4 weeks
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)
    date_rangeTime Frame:
    Every 4 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • Changes in corrected serum calcium level
    date_rangeTime Frame:
    Every 4 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • Changes in the product of serum calcium and phosphate
    date_rangeTime Frame:
    Every 4 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • Changes in serum intact-PHT levels
    date_rangeTime Frame:
    Every 4 weeks
    enhanced_encryption
    Safety Issue:
    yes
  • Changes in bone metabolism markers
    date_rangeTime Frame:
    Every 4 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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