Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

Hyperphosphatemia Clinical Trial

Official title:

An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187628
• Other study ID #: 15074
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2010
• Last updated: April 2, 2015
• Start date: September 2010
• Est. completion date: April 2013

Study information

• Verified date: April 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).

Exclusion Criteria:

• Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Fosrenol (Lanthanum Carbonate, BAY77-1931)
Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Shire

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment emergent adverse events		baseline to Week 60	Yes

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