Fosrenol Post-marketing Surveillance in Japan

ID: NCT01955876
Status: Completed
Phase: N/A
Start Date: October 10, 2013
First Submitted: September 06, 2013
Last Updated: February 22, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: Japan
Conditions: Hyperphosphatemia, Kidney Disease
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Study Description

Brief Summary

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Hyperphosphatemia

Kidney Disease

Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931)
Other Names
N/A

Tracking Information

First Submitted DateSeptember 06, 2013
Last Update Posted DateFebruary 22, 2018
Actual Start DateOctober 10, 2013
Actual Completion DateAugust 05, 2016
Actual Primary Completion DateFebruary 18, 2016
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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)]

  • Adverse drug event rate related to the digestive system [Time Frame: 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)]

  • 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)]

  • 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]

  • 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]

  • 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]

  • 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)]

  • 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]

  • 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)]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleFosrenol Post-marketing Surveillance in Japan
Official TitleDrug Use Investigation of Fosrenol for Hyperphosphatemia With Chronic Kidney Disease Not on Dialysis
Brief Summary

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.

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
343
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Hyperphosphatemia
Kidney Disease
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationChronic renal failure patients who have not been treated with dialysis and will be treated with Fosrenol for hyperphosphatemia
Intervention
Drug: Lanthanum Carbonate (Fosrenol, BAY77-1931)

Patients treated with Fosrenol in daily clinical practice.

Other Names
Study Groups/Cohorts
Group 1

Study Arms
Group 1
Drug : Lanthanum Carbonate (Fosrenol, BAY77-1931)
Patients treated with Fosrenol in daily clinical practice.

Arm Intervention/Treatment
Group 1
Drug : Lanthanum Carbonate (Fosrenol, BAY77-1931)

Recruitment Information

Recruitment Status:Completed
Enrollment343
Completion DateAugust 05, 2016
Eligibility Criteria: 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
GenderAll
Age N/A to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Japan

Administrative Information

NCT Number:NCT01955876
Other Study ID Numbers
16626
FOSRENOL-PRED
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer