NCT00110656

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2004

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2005

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2011

Enrollment Period

6 months

First QC Date

May 12, 2005

Last Update Submit

January 20, 2011

Conditions

Kidney Transplantation

Keywords

Kidney transplant

Outcome Measures

Primary Outcomes (1)

  • PTH Values

    12 months post kidney translplant

Secondary Outcomes (1)

  • Calcium and Phosphorus

    12 months post kidney transplant

Study Arms (1)

Kidney Transplant

All patients entered into the study will have received a kidney transplant.

Other: Observations

Interventions

ObservationsOTHER

This is a non-interventional study- only observational.

Kidney Transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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Patients with Secondary HPT and ESRD who previously qualified for Amgen AM 073 studies but were withdrawn due to kidney transplant.

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- Patient has any kind of disorder that compromises the ability of the subject to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Biospecimen

Retention: NONE RETAINED

Retrospective data collected.

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 12, 2005

First Posted

May 13, 2005

Study Start

March 1, 2004

Primary Completion

September 1, 2004

Study Completion

October 1, 2004

Last Updated

January 21, 2011

Record last verified: 2011-01