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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: Lanthanum carbonate (BAY77-1931); Drug: Calcium carbonate

• Study Type: Interventional
• Enrollment (Actual): 259
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • 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
  • Aichi
    • Toyohashi, Aichi, Japan, 441-8023
    • Yatomi, Aichi, Japan, 498-0006
  • Chiba
    • Asahi, Chiba, Japan, 289-2511
    • Kashiwa, Chiba, Japan, 277-0084
    • Matsudo, Chiba, Japan, 271-0077
    • Narita, Chiba, Japan, 286-0041
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-8522
    • Kurume, Fukuoka, Japan, 830-8543
  • Gunma
    • Isesaki, Gunma, Japan, 379-2211
  • Hyogo
    • Kobe, Hyogo, Japan, 658-0084
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0844
    • Tsuchiura, Ibaraki, Japan, 300-0053
  • Kagawa
    • Takamatsu, Kagawa, Japan, 761-8024
  • Miyagi
    • Osaki, Miyagi, Japan, 989-6117
    • Sendai, Miyagi, Japan, 981-0912
  • Osaka
    • Suita, Osaka, Japan, 564-0053
  • Shizuoka
    • Fuji, Shizuoka, Japan, 417-0056
    • Hamamatsu, Shizuoka, Japan, 430-0903
  • Tokyo
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period	baseline to week 8
Presence/absence of incidence of hypercalcemia up to 8 weeks	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants achieving target PSPL and time to achievement	up to 8 weeks
Serum calcium x phosphate product at the end of the double-blind treatment period	Week 8
Serum intact-PTH (Parathyroid) levels	Week 8
Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period	Week 8
Number of participants achieving the target serum calcium levels	Week 8
Safety variables will be summarized using descriptive statistics based on adverse events collection	8 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (ACTUAL): May 1, 2006
• Study Completion (ACTUAL): May 1, 2006

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (ESTIMATE): January 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2012
• Last Update Submitted That Met QC Criteria: June 7, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis
• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Antacids; Calcium; Calcium Carbonate
• Other Study ID Numbers: 11877