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OpenTrials
Completed

NCT Number: NCT00110656

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observations

Other

This is a non-interventional study- only observational.

Primary outcomes

  1. PTH Values

    Time frame: 12 months post kidney translplant

Secondary outcomes

  1. Calcium and Phosphorus

    Time frame: 12 months post kidney transplant

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
May 13, 2005
Registry last updated
Jan 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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