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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00110656
First Posted: May 13, 2005
Last Update Posted: January 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
May 12, 2005
May 13, 2005
January 21, 2011
March 2004
September 2004   (Final data collection date for primary outcome measure)
PTH Values [ Time Frame: 12 months post kidney translplant ]
Not Provided
Complete list of historical versions of study NCT00110656 on ClinicalTrials.gov Archive Site
Calcium and Phosphorus [ Time Frame: 12 months post kidney transplant ]
Not Provided
Not Provided
Not Provided
 
Study To Evaluate the Status of Subjects That Discontinued Participation in a Qualifying Amgen Sponsored AMG 073 Study Due to Kidney Transplantation
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
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.
Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Retention:   None Retained
Description:
Retrospective data collected.
Non-Probability Sample
Patients with Secondary HPT and ESRD who previously qualified for Amgen AM 073 studies but were withdrawn due to kidney transplant.
Kidney Transplantation
Other: Observations
This is a non-interventional study- only observational.
Kidney Transplant
All patients entered into the study will have received a kidney transplant.
Intervention: Other: Observations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
October 2004
September 2004   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Austria,   Belgium,   Finland,   Germany,   Italy,   Portugal,   Spain,   United States
 
NCT00110656
20030219
Not Provided
Not Provided
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2011