check_circleStudy Completed

Hyperphosphatemia, kidney disease

Bayer Identifier:

16626

ClinicalTrials.gov Identifier:

NCT01955876

EudraCT Number:

Not Available

EU CT Number:

Not Available
Fosrenol post-marketing surveillance in Japan

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

N/A N/A
  • - 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”.
  • - Patients who are contraindicated based on the product label.
    - Patients who have been already treated with Fosrenol

Trial summary

Enrollment Goal
343
Trial Dates
October 2013 - August 2016
Phase
N/A
Could I Receive a placebo
No
Products
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Incidence/number of episodes of adverse drug reactions and adverse events
    date_rangeTime Frame:
    6 months after start of treatment with the drug
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incidence/number of episodes of adverse drug reactions and adverse events
    date_rangeTime Frame:
    until the conduction of dialysis after starting the treatment with Lanthanum carbonate(Maximum 2 years)
    enhanced_encryption
    Safety Issue:
    Yes
  • Adverse drug event rate related to the digestive system
    date_rangeTime Frame:
    until the conduction of dialysis(Maximum 2 years)
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    until the conduction of dialysis(Maximum 2 years)
    enhanced_encryption
    Safety Issue:
    Yes
  • 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.
    date_rangeTime Frame:
    until the conduction of dialysis(Maximum 2 years)
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime 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
    date_rangeTime 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).
    date_rangeTime 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).
    date_rangeTime 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).
    date_rangeTime 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).
    date_rangeTime Frame:
    until the conduction of dialysis(Maximum 2 years)

Trial design

Drug Use Investigation of Fosrenol for Hyperphosphatemia with chronic kidney disease not on dialysis
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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