NCT00151918

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2005

Shorter than P25 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

January 7, 2005

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2005

Completed
16 days 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
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

September 7, 2005

Last Update Submit

July 1, 2021

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

  • Mean pre-dialysis serum phosphate level

    The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

Secondary Outcomes (4)

  • Mean pre-dialysis serum calcium product

    The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

  • Mean pre-dialysis calcium-phosphate product

    The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

  • Average daily pill burden

    Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.

  • Treatment emergent adverse events

    Throughout the study period of approximately 7.5 months.

Interventions

Lanthanum carbonateDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients receiving haemodialysis for ESRD
  • Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months

You may not qualify if:

  • Pregnant or lactating women
  • Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
  • Patients who are HIV+
  • Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

January 7, 2005

Primary Completion

August 22, 2005

Study Completion

August 22, 2005

Last Updated

July 6, 2021

Record last verified: 2021-07