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

Completed

• Conditions: Kidney Transplantation
• Interventions: Other: Observations

• Registration Number: NCT00110656
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2004-09
• Study Completion: 2004-10
• Study First Submitted: 2005-05-12
• Study First Submitted QC: 2005-05-12
• Study First Posted: 2005-05-13
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Kidney Transplant	Observations	All patients entered into the study will have received a kidney transplant.

Primary Outcome Measures

Name	Time	Method
PTH Values	12 months post kidney translplant

Secondary Outcome Measures

Name	Time	Method
Calcium and Phosphorus	12 months post kidney transplant