BAY 77-1931 Long-term Extension From Phase II Study

A Long-term, Open Label Extension, Non-controlled Study to Assess the Efficacy and Safety of BAY 77-1931 (Lanthanum Carbonate) for Hyperphosphatemia in Patients Undergoing Hemodialysis

A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: BAY 77-1931

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan, 261-0011
  • Hiroshima, Japan, 730-0811
  • Kochi, Japan, 780-0066
  • Kochi, Japan, 780-8040
  • Kochi, Japan, 781-5103
  • Okayama, Japan, 701-0202
  • Tokushima, Japan, 770-0011
  • Aichi
    • Toyohashi, Aichi, Japan, 441-8023
    • Yatomi, Aichi, Japan, 498-0006
  • Chiba
    • Kashiwa, Chiba, Japan, 277-0084
    • Narita, Chiba, Japan, 286-0041
    • Sakura, Chiba, Japan, 285-0846
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 070-0030
  • Osaka
    • Suita, Osaka, Japan, 564-0053

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:

• Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least

Exclusion Criteria:

• Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: BAY 77-1931; Lanthanum Carbonate (BAY 77-1931)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in pre-dialysis serum phosphate levels	Every 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)	Every 4 weeks
Changes in corrected serum calcium level	Every 4 weeks
Changes in the product of serum calcium and phosphate	Every 4 weeks
Changes in serum intact-PHT levels	Every 4 weeks
Changes in bone metabolism markers	Every 4 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: October 8, 2008
• First Submitted That Met QC Criteria: October 8, 2008
• First Posted (Estimate): October 9, 2008

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: January 21, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: 11551 (DAIDS ES Registry Number)