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:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00110656
First received: May 12, 2005
Last updated: January 20, 2011
Last verified: January 2011

May 12, 2005
January 20, 2011
March 2004
September 2004   (final data collection date for primary outcome measure)
PTH Values [ Time Frame: 12 months post kidney translplant ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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Patients with Secondary HPT and ESRD who previously qualified for Amgen AM 073 studies but were withdrawn due to kidney transplant.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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00110656
20030219
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP