check_circleStudy Completed

Hyperphosphatemia, Dialysis

Bayer Identifier:

11810

ClinicalTrials.gov Identifier:

NCT00767637

EudraCT Number:

Not Available

EU CT Number:

Not Available
Long-term treatment on BAY77-1931 (lanthanum carbonate) to measure lanthanum concentrations in bone

Trial purpose

To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis

Key Participants Requirements

Sex

Both

Age

20 - N/A

  • - Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication

  • - Patients with severe hypocalcemia (adjusted serum calcium level of <7.5 mg/dL)

Trial summary

Enrollment Goal
14
Trial Dates
June 2005 - October 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sanin Rosai HospitalYonago, 683-0002, Japan
Completed
Seseragi HospitalIsesaki, 379-2211, Japan

Primary Outcome

  • Changes in pre-dialysis serum phosphate levels
    date_rangeTime Frame:
    Every 2 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)
    date_rangeTime Frame:
    Every 2 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in corrected serum calcium level
    date_rangeTime Frame:
    Every 2 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in the product of serum calcium and phosphate
    date_rangeTime Frame:
    Every 2 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in serum intact-PHT levels
    date_rangeTime Frame:
    Every 2 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Changes in bone metabolism markers
    date_rangeTime Frame:
    Every 2 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Open label, non-controlled long-term treatment on BAY77-1931 (lanthanum carbonate) to measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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