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

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

Study Type: Observational
Study Design: Time Perspective: 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

Resource links provided by NLM:

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

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.


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Patients with Secondary HPT and ESRD who previously qualified for Amgen AM 073 studies but were withdrawn due to kidney transplant.


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 identifier: NCT00110656

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00110656     History of Changes
Other Study ID Numbers: 20030219
Study First Received: May 12, 2005
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Kidney transplant processed this record on April 17, 2014