NCT00151931

Brief Summary

The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate

Trial Health

100
On Track

Trial Health Score

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

Enrollment
456

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2004

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

May 11, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2006

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.7 years

First QC Date

September 7, 2005

Last Update Submit

June 2, 2021

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5

    Week 3 and Week 5

Secondary Outcomes (1)

  • Treatment emergent adverse events

    Throughout the study period of approximately 20 months.

Interventions

Lanthanum carbonateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females of childbearing potential agree to take adequate precautions to prevent contraception
  • Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study
  • Patient requires treatment for hyperphosphataemia

You may not qualify if:

  • Pregnant or lactating women
  • Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium
  • Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
  • Patients who are HIV+
  • Patients with any significant gastrointestinal surgery or disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hutchison AJ, Laville M; SPD405-313 Lanthanum Study Group. Switching to lanthanum carbonate monotherapy provides effective phosphate control with a low tablet burden. Nephrol Dial Transplant. 2008 Nov;23(11):3677-84. doi: 10.1093/ndt/gfn310. Epub 2008 Jun 24.

    PMID: 18577536BACKGROUND

Related Links

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 7, 2005

First Posted

September 9, 2005

Study Start

May 11, 2004

Primary Completion

January 12, 2006

Study Completion

January 12, 2006

Last Updated

June 8, 2021

Record last verified: 2021-06