Long-term Effect of Lanthanum Carbonate on Bone

NCT00557323 | Completed Results

• 1 other identifier: SPD405-402
• Study Type: observational
• Target: 34
• Locations: 3 countries
• Sites: 19

Brief Summary

Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being observed for any bone adverse events or other serious adverse events, as well as the collection of mortality data.

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• Number of Study-emergent Bone-related Adverse Events (AEs)

  5 years

Secondary Outcomes (1)

• Number of Study-emergent Deaths

  5 years

Study Arms (1)

1

Patients being treated for hyperphosphatemia with any marketed product

Drug: Lanthanum carbonate

Interventions

Lanthanum carbonate DRUG

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patients from study SPD405-309 who were exposed to lanthanum carbonate

You may qualify if:

• Any patient who had exposure to lanthanum carbonate in SPD405-309

Sponsors & Collaborators

• Shire: lead

Study Sites (19)

Imperial care Dialysis Center

Lynwood, California, 90262, United States

Location

Barnett Research and Communications Medical Group

Torrance, California, 90503-4100, United States

Location

Western new England Renal & Transplant Associates

Springfield, Massachusetts, 01107, United States

Location

Mercy Medical Center

Canton, Ohio, 44708, United States

Location

Hypertension & Nephrology, Inc.

Providence, Rhode Island, 02904, United States

Location

Nephrology Associates, PC

Nashville, Tennessee, 37205, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Nephrology Associates, PC

Richmond, Virginia, 23226-2022, United States

Location

Unknown Facility

Bad König, Hesse, 64732, Germany

Location

KfH Zentrum

Aachen, 52074, Germany

Location

Dialysenzentrum

Bad Homburg, 61348, Germany

Location

KfH Kuratorium duer Dialyse und Nierentransplanta Dialysezentrum Moabit

Berlin, 10559, Germany

Location

KfH Dialysezentrum

Berlin, 12045, Germany

Location

Dialysezentrum Barmbek

Hamburg, 22297, Germany

Location

Dialysepraxis Altona

Hamburg, 22767, Germany

Location

KfH Dialysezentrum

Rosenheim, 83022, Germany

Location

Addenbrooke's Hospital

Cambridge, CAMBS CB2 2QQ, United Kingdom

Location

St. Helier Hospital

Carshalton, GT LON SM5 1AA, United Kingdom

Location

Manchester Royal Infirmary

Manchester, GT MAN M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2007
• First Posted: November 14, 2007
• Study Start: March 15, 2007
• Primary Completion: August 31, 2010
• Study Completion: August 31, 2010
• Last Updated: July 13, 2021
• Results First Posted: June 15, 2011

Record last verified: 2021-06

Locations

DE (8); US (8); GB (3)