Study To Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00110656

Purpose

The purpose of this study is to collect local laboratory data on immunoreactive parathyroid hormone (iPTH), calcium and phosphorus levels and estimated glomerular filtration rate (GFR) at approximately 1 week, 1 month, 3 months, 6 months and 12 months after the kidney transplant.

Condition	Intervention
Kidney Transplantation	Other: Observations

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cinacalcet Cinacalcet hydrochloride

U.S. FDA Resources

Study Type:	Observational
Study Design:	Retrospective
Official Title:	A Retrospective Follow Up Study to Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation

Further study details as provided by Amgen:

Primary Outcome Measures:

PTH Values [ Time Frame: 12 months post kidney translplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Calcium and Phosphorus [ Time Frame: 12 months post kidney transplant ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Retrospective data collected.

Enrollment:	38
Study Start Date:	March 2004
Study Completion Date:	October 2004
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Kidney Transplant All patients entered into the study will have received a kidney transplant.	Other: Observations This is a non-interventional study- only observational.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with Secondary HPT and ESRD who previously qualified for Amgen AM 073 studies but were withdrawn due to kidney transplant.

Criteria

Inclusion Criteria:

- Patients who withdrew from one of the qualifying studies (i.e. patient previously took part in an Amgen study investigating the drug AMG 073 and its effects on secondary hyperparathyroidism [HPT]; in particular parathyroid hormone [PTH], calcium and phosphorus levels in blood associated with kidney failure) due to kidney transplantation.

Exclusion Criteria:

- Patient has any kind of disorder that compromises the ability of the subject to give written informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110656

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20030219
Study First Received:	May 12, 2005
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00110656
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Kidney transplant

ClinicalTrials.gov processed this record on January 16, 2009