Study To Evaluate the Status of Subjects That Discontinue... | NCT00110656

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

NCT00110656

Sponsor

Amgen

Status

Completed

Last Update Posted

Jan 21, 2011Estimated

Enrollment

38Actual

Phase

Not provided

Conditions

Kidney Transplantation

Interventions

Observations

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Sep 2004Actual

Completion Date

Oct 2004Actual

First Submitted Date

May 12, 2005

First Submission Date that Met QC Criteria

May 12, 2005

First Posted Date

May 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2011

Last Update Posted Date

Jan 21, 2011Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kidney Transplant		All patients entered into the study will have received a kidney transplant.	Other: Observations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observations	Other	This is a non-interventional study- only observational.	Kidney Transplant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PTH Values		12 months post kidney translplant

Secondary Outcomes

Measure	Description	Time Frame
Calcium and Phosphorus		12 months post kidney transplant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
MD	Amgen	Study Director

Label	URL
AmgenTrials clinical trials website	View source

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided