Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01514851
First received: January 18, 2012
Last updated: June 7, 2012
Last verified: June 2012

January 18, 2012
June 7, 2012
January 2006
May 2006   (final data collection date for primary outcome measure)
  • Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • Presence/absence of incidence of hypercalcemia up to 8 weeks [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01514851 on ClinicalTrials.gov Archive Site
  • Number of participants achieving target PSPL and time to achievement [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Serum calcium x phosphate product at the end of the double-blind treatment period [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Serum intact-PTH (Parathyroid) levels [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Number of participants achieving the target serum calcium levels [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate
Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperphosphatemia
  • Drug: Lanthanum carbonate (BAY77-1931)
  • Drug: Calcium carbonate
  • Experimental: Arm 1
    750-2250mg/day, tid (three times a day), 8 weeks
    Intervention: Drug: Lanthanum carbonate (BAY77-1931)
  • Active Comparator: Arm 2
    1500-4500mg/day, tid, 8 weeks
    Intervention: Drug: Calcium carbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
259
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01514851
11877
No
Head Medical Development Japan, Bayer Yakuhin Ltd.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP