Efficacy and Tolerability of Treatment With Lanthanum Car... | NCT00151931

Studies
Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis

NCT00151931

Sponsor

Shire

Status

Completed

Last Update Posted

Jun 8, 2021Actual

Enrollment

456

Phase

Phase 3

Conditions

Kidney Failure, Chronic

Interventions

Lanthanum carbonate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 11, 2004Actual

Primary Completion Date

Jan 12, 2006Actual

Completion Date

Jan 12, 2006Actual

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 9, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2021

Last Update Posted Date

Jun 8, 2021Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

456

Name	Type	Description	Arm Group Labels	Other Names
Lanthanum carbonate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in pre-dialysis serum phosphate levels at Week 3 compared with Week 5		Week 3 and Week 5

Secondary Outcomes

Measure	Description	Time Frame
Treatment emergent adverse events		Throughout the study period of approximately 20 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Study Director	Takeda	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18577536	Background	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.

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases