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Post Transplant Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00395902
Recruitment Status : Completed
First Posted : November 6, 2006
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:
Amgen

Tracking Information
First Submitted Date November 2, 2006
First Posted Date November 6, 2006
Last Update Posted Date December 28, 2007
Study Start Date August 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00395902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Transplant Study
Official Title A Retrospective Evaluation of Sensipar Use in Renal Transplant Recipients
Brief Summary Retrospective chart review to gather information on Sensipar patterns of use and effects on biochemical parameters in renal transplant recipients
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Kidney Tansplant
  • Secondary Hyperparathyroidism
  • Hyperparathyroidism
Intervention Drug: Sensipar after Post Transplant
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: November¬†2,¬†2006)
50
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Adults >= 18 years old
  • Subjects who have received Sensipar for a duration of at least 3 months, beginning at least 3 months after a kidney transplant. Subjects must have begun Sensipar teatment no later than Februry 28, 2005 at treating physician's discretion.

Exclusion Criteria:

  • Subjects who received Sensipar before undergoing a kidney transplant
  • Subjects receiving dialysis post-transplant
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00395902
Other Study ID Numbers 20040261
2004261
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Global Development Leader, Amgen Inc.
Study Sponsor Amgen
Collaborators Not Provided
Investigators
Study Director: MD Amgen
PRS Account Amgen
Verification Date December 2007