Skip to main content
OpenTrials
Completed

NCT Number: NCT01955876

Fosrenol Post-marketing Surveillance in Japan

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperphosphatemia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Disease Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanthanum Carbonate (Fosrenol, BAY77-1931)

Drug

Patients treated with Fosrenol in daily clinical practice.

Primary outcomes

  1. Incidence/number of episodes of adverse drug reactions and adverse events

    Time frame: 6 months after start of treatment with the drug

Secondary outcomes

  1. 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)

  2. Adverse drug event rate related to the digestive system

    Time frame: until the conduction of dialysis(Maximum 2 years)

  3. 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)

  4. 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)

  5. 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. 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

  7. 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

  8. 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)

  9. 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

  10. 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2013
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.