Fosrenol Post-marketing Surveillance in Japan

February 22, 2018 updated by: Bayer

Drug Use Investigation of Fosrenol for Hyperphosphatemia With Chronic Kidney Disease Not on Dialysis

This study is a regulatory post-marketing surveillance in Japan and it is a local prospective and observational study of patients who have received Fosrenol.

The objective of this research is to collect information on the safety of Fosrenol after its launching, which means collecting information on adverse events, especially adverse events in the digestive system including constipation and serious adverse events, and adverse drug reactions when the drug is administered to the below-mentioned target patients for six months.

The secondary objective is to collect information on the safety of the drug when administered for more than six months, which means collecting information on the safety of the drug when administered for up to 12 months to the target patients who have already been treated with the drug for six months. And also if at the time of 12 months after administration of Lanthanum carbonate the dialysis is not conducted, extending its' administration will be continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone) level change.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

343

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Multiple Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic renal failure patients who have not been treated with dialysis and will be treated with Fosrenol for hyperphosphatemia

Description

Inclusion Criteria:

  • Patients whom investigators have decided to treat with Lanthanum carbonate for the first time at the respective medical institutions. Those medical institutions have to understand the objective of this investigation and conclude a written contract with Bayer Yakuhin.
  • The decision to treat patients with Lanthanum carbonate will be made independently by the investigator prior to study inclusion.
  • Patients treated with Lanthanum carbonate in the indication "Hyperphosphatemia" with chronic kidney disease not on dialysis".

Exclusion Criteria:

  • Patients who are contraindicated based on the product label.
  • Patients who have been already treated with Fosrenol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Patients treated with Fosrenol in daily clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence/number of episodes of adverse drug reactions and adverse events
Time Frame: 6 months after start of treatment with the drug
6 months after start of treatment with the drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence/number of episodes of adverse drug reactions and adverse events
Time Frame: until the conduction of dialysis after starting the treatment with Lanthanum carbonate(Maximum 2 years)
until the conduction of dialysis after starting the treatment with Lanthanum carbonate(Maximum 2 years)
Adverse drug event rate related to the digestive system
Time Frame: until the conduction of dialysis(Maximum 2 years)
until the conduction of dialysis(Maximum 2 years)
Incidence/number of episodes of adverse events for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate.
Time Frame: until the conduction of dialysis(Maximum 2 years)
until the conduction of dialysis(Maximum 2 years)
Incidence/number of episodes of adverse drug reactions for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate according to patient characteristics and treatment with Lanthanum carbonate.
Time Frame: until the conduction of dialysis(Maximum 2 years)
until the conduction of dialysis(Maximum 2 years)
Serum P level for six months after start of treatment with the drug in comparison with baseline (at the time of start of treatment with fosrenol)
Time Frame: 6 months after start of treatment with the drug
6 months after start of treatment with the drug
Serum intact PTH level for six months after start of treatment with the drug in comparison with baseline
Time Frame: 6 months after start of treatment with the drug
6 months after start of treatment with the drug
Serum P level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol).
Time Frame: 12 months
12 months
Serum P level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol).
Time Frame: until the conduction of dialysis(Maximum 2 years)
until the conduction of dialysis(Maximum 2 years)
Serum intact PTH level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate).
Time Frame: 12 months
12 months
Serum intact PTH level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate).
Time Frame: until the conduction of dialysis(Maximum 2 years)
until the conduction of dialysis(Maximum 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2013

Primary Completion (ACTUAL)

February 18, 2016

Study Completion (ACTUAL)

August 5, 2016

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 30, 2013

First Posted (ESTIMATE)

October 8, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 16626
  • FOSRENOL-PRED (OTHER: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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