Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 815-0082
  • Gifu, Japan, 500-8717
  • Hiroshima, Japan, 730-8655
  • Okayama, Japan, 700-0013
  • Tokushima, Japan, 770-0011
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-0030
  • Kanagawa
    • Kamakura, Kanagawa, Japan, 247-0072
    • Yokosuka, Kanagawa, Japan, 238-0011
  • Miyagi
    • Osaki, Miyagi, Japan, 989-6117
    • Sendai, Miyagi, Japan, 981-0912
  • Tokyo
    • Meguro-ku, Tokyo, Japan, 153-0061

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period
• Out-patient
• Undergoing CAPD for at least previous 3 consecutive months

Exclusion Criteria:

• Who may not enable to continue CAPD
• Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
• Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 750-2250mg/day, tid, 8 weeks	Drug: Lanthanum Carbonate (BAY77-1931)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in serum phosphate levels at the end of the treatment period	Baseline to Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Estimate): March 14, 2016
• Last Update Submitted That Met QC Criteria: March 10, 2016
• Last Verified: March 1, 2016

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
• Other Study ID Numbers: 11878