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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01187628

Enrollment

123

Registered

2010-08-24

Start date

2010-09-30

Completion date

2013-04-30

Last updated

2015-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperphosphatemia

Keywords

Long-term study in Chronic Kidney Disease, Lanthanum Carbonate

Brief summary

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.

Interventions

DRUGFosrenol (Lanthanum Carbonate, BAY77-1931)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of treatment emergent adverse events	baseline to Week 60

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026