check_circleStudy Completed

Hyperphosphatemia

Bayer Identifier:

11877

ClinicalTrials.gov Identifier:

NCT01514851

EudraCT Number:

Not Available

EU CT Number:

Not Available
Phase III double-blind comparative study of BAY77-1931 (Lanthanum Carbonate) with Calcium carbonate

Trial purpose

To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.

Key Participants Requirements

Sex

Both

Age

20 Years
  • - Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.
    - Out-patient
    - Undergoing hemodialysis three times per week for at least previous 3 consecutive months
  • - Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
    - Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 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
    - Requiring treatment for hypothyroidism

Trial summary

Enrollment Goal
259
Trial Dates
January 2006 - May 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
Mihama HospitalChiba, 261-0011, Japan
Completed
Mihama Narita ClinicNarita, 286-0041, Japan
Completed
Shin Kashiwa ClinicKashiwa, 277-0084, Japan
Completed
Sendai Shakaihoken HospitalSendai, 981-0912, Japan
Completed
Meiyo ClinicToyohashi, 441-8023, Japan
Completed
Ama Kyoritsu ClinicYatomi, 498-0006, Japan
Completed
Shigei Medical Research HospitalOkayama, 701-0202, Japan
Completed
Nakajima Tsuchiya ClinicHiroshima, 730-0811, Japan
Completed
Kawashima HospitalTokushima, 770-0011, Japan
Completed
Kinashi-Obayashi HospitalTakamatsu, 761-8024, Japan
Completed
Shimazu HospitalKochi, 780-0066, Japan
Completed
Tokai HospitalNerima-ku, 176-0023, Japan
Completed
Maruyama HospitalHamamatsu, 430-0903, Japan
Completed
Inoue HospitalSuita, 564-0053, Japan
Completed
Seseragi HospitalIsesaki, 379-2211, Japan
Completed
Eijinkai HospitalOsaki, 989-6117, Japan
Completed
Yuai ClinicSaitama, 330-0854, Japan
Completed
Yuai Nakagawa ClinicSaitama, 337-0043, Japan
Completed
Yuai Mihashi ClinicSaitama, 330-0856, Japan
Completed
Sumiyoshi Clinic HospitalMito, 310-0844, Japan
Completed
Tsuchiurakyodo General HospitalTsuchiura, 300-0053, Japan
Completed
Tokatsu Clinic MatsudoMatsudo, 271-0077, Japan
Completed
Asahi Central HospitalAsahi, 289-2511, Japan
Completed
Minami-senju HospitalArakawa-ku, 116-0003, Japan
Completed
Shinjuku Koshin ClinicShinjyuku-ku, 160-0023, Japan
Completed
Bosei Shinjuku South ClinicShibuya-ku, 151-0053, Japan
Completed
Kodaira North ClinicKodaira, 187-0001, Japan
Completed
Fuji First ClinicFuji, 417-0056, Japan
Completed
Sumiyoshigawa HospitalKobe, 658-0084, Japan
Completed
St.Mary's HospitalKurume, 830-8543, Japan
Completed
Koga ClinicKurume, 830-8522, Japan

Primary Outcome

  • Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period
    date_rangeTime Frame:
    baseline to week 8
    enhanced_encryption
    Safety Issue:
    No
  • Presence/absence of incidence of hypercalcemia up to 8 weeks
    date_rangeTime Frame:
    up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of participants achieving target PSPL and time to achievement
    date_rangeTime Frame:
    up to 8 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Serum calcium x phosphate product at the end of the double-blind treatment period
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Serum intact-PTH (Parathyroid) levels
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period
    date_rangeTime Frame:
    Week 8
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants achieving the target serum calcium levels
    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 double-blind comparative study of BAY 77 1931 (Lanthanum Carbonate) with a calcium carbonate in patients with hyperphosphatemia undergoing hemodialysis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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