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

Hyperphosphatemia Clinical Trial

Official title:

Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514851
• Other study ID #: 11877
• Status: Completed
• Phase: Phase 3
• First received: January 18, 2012
• Last updated: June 7, 2012
• Start date: January 2006
• Est. completion date: May 2006

Study information

• Verified date: June 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

Drug:
• Lanthanum carbonate (BAY77-1931)

• Calcium carbonate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period		baseline to week 8	No
Primary	Presence/absence of incidence of hypercalcemia up to 8 weeks		up to 8 weeks	No
Secondary	Number of participants achieving target PSPL and time to achievement		up to 8 weeks	No
Secondary	Serum calcium x phosphate product at the end of the double-blind treatment period		Week 8	No
Secondary	Serum intact-PTH (Parathyroid) levels		Week 8	No
Secondary	Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period		Week 8	No
Secondary	Number of participants achieving the target serum calcium levels		Week 8	No
Secondary	Safety variables will be summarized using descriptive statistics based on adverse events collection		8 weeks	Yes

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