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

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

Condition Intervention Phase
Drug: Lanthanum carbonate (BAY77-1931)
Drug: Calcium carbonate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 259
Study Start Date: January 2006
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
750-2250mg/day, tid (three times a day), 8 weeks
Drug: Lanthanum carbonate (BAY77-1931)
Active Comparator: Arm 2
1500-4500mg/day, tid, 8 weeks
Drug: Calcium carbonate


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01514851

Toyohashi, Aichi, Japan, 441-8023
Yatomi, Aichi, Japan, 498-0006
Asahi, Chiba, Japan, 289-2511
Kashiwa, Chiba, Japan, 277-0084
Matsudo, Chiba, Japan, 271-0077
Narita, Chiba, Japan, 286-0041
Kurume, Fukuoka, Japan, 830-8522
Kurume, Fukuoka, Japan, 830-8543
Isesaki, Gunma, Japan, 379-2211
Kobe, Hyogo, Japan, 658-0084
Mito, Ibaraki, Japan, 310-0844
Tsuchiura, Ibaraki, Japan, 300-0053
Takamatsu, Kagawa, Japan, 761-8024
Osaki, Miyagi, Japan, 989-6117
Sendai, Miyagi, Japan, 981-0912
Suita, Osaka, Japan, 564-0053
Fuji, Shizuoka, Japan, 417-0056
Hamamatsu, Shizuoka, Japan, 430-0903
Arakawa-ku, Tokyo, Japan, 116-0003
Kodaira, Tokyo, Japan, 187-0001
Nerima-ku, Tokyo, Japan, 176-0023
Shibuya-ku, Tokyo, Japan, 151-0053
Shinjyuku-ku, Tokyo, Japan, 160-0023
Chiba, Japan, 261-0011
Hiroshima, Japan, 730-0811
Kochi, Japan, 780-0066
Okayama, Japan, 701-0202
Saitama, Japan, 330-0854
Saitama, Japan, 330-0856
Saitama, Japan, 337-0043
Tokushima, Japan, 770-0011
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Head Medical Development Japan, Bayer Yakuhin Ltd. Identifier: NCT01514851     History of Changes
Other Study ID Numbers: 11877 
Study First Received: January 18, 2012
Last Updated: June 7, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis

Additional relevant MeSH terms:
Metabolic Diseases
Phosphorus Metabolism Disorders
Calcium Carbonate
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on April 27, 2016