Skip to main content
OpenTrials
Completed

NCT Number: NCT01187628

Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anjo, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).

Exclusion criteria

  • Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study

Treatment and study plan

Fosrenol (Lanthanum Carbonate, BAY77-1931)

Drug

Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.

Primary outcomes

  1. Incidence of treatment emergent adverse events

    Time frame: baseline to Week 60

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Shire

Registry information

Official study title

An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 24, 2010
Registry last updated
Apr 3, 2015

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.