NCT00150540

Brief Summary

The purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2002

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2002

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

2.7 years

First QC Date

September 6, 2005

Last Update Submit

June 18, 2021

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • Treatment emergent adverse events

    Up to 24 months

Secondary Outcomes (3)

  • Changes in pre-dialysis serum phosphate levels

    Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.

  • Control of pre-dialysis serum phosphate levels

    Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.

  • Plasma lanthanum levels

    Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.

Interventions

Lanthanum carbonateDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who participated in LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 and received lanthanum carbonate
  • Patients must continue to require treatment with a phosphate binder for hyperphosphatemia
  • male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter

You may not qualify if:

  • Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
  • Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

October 14, 2002

Primary Completion

June 29, 2005

Study Completion

June 29, 2005

Last Updated

June 23, 2021

Record last verified: 2021-06