Overview

This trial is active, not recruiting.

Condition hyperphosphatemia
Treatment lanthanum carbonate (fosrenol, bay77-1931) - chewable tablet
Sponsor Bayer
Start date April 2009
End date April 2014
Trial size 3000 participants
Trial identifier NCT01412398, 15076

Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous cyclic peritoneal dialysis (CCPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CCPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Drug (incl. Placebo)
lanthanum carbonate (fosrenol, bay77-1931) - chewable tablet
Patients in CCPD who have received Fosrenol for hyperphosphatemia

Primary Outcomes

Measure
Incidence of adverse drug reactions in subjects who received Fosrenol
time frame: After Fosrenol administration, up to 1 year
Incidence of serious adverse events in subjects who received Fosrenol
time frame: After Fosrenol administration, up to 1 year

Secondary Outcomes

Measure
Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol
time frame: After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL]
time frame: After Fosrenol administration, up to 1 year
Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL]
time frame: After Fosrenol administration, up to 1 year
Clinical test value collections [calciotropic hormones, bone turnover markers]
time frame: After Fosrenol administration, up to 1 year

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients undergoing continuous cyclic peritoneal dialysis who received Fosrenol for hyperphosphatemia Exclusion Criteria: - Patients who are contraindicated based on the product label

Additional Information

Official title Special Drug Use Investigation of Fosrenol (Investigation for Patients With Continuous Cyclic Peritoneal Dialysis)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.