Status:
COMPLETED
A Prospective Cohort Study to Describe the Evolution of Persistent Hyperparathyroidism in Kidney Transplant Recipients
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Amgen
Conditions:
Hyperparathyroidism
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to see if Hyperparathyroidism (HPT) is common in people who receive a kidney transplant. Patients with HPT often have high parathyroid hormone (PTH) levels and may have la...
Detailed Description
Subjects are enrolled in the study and a 12-month observational phase will begin. During the observational phase, subjects will attend a total of 8 visits at approximately 1, 2, 4, and 8 weeks after k...
Eligibility Criteria
Inclusion
- diagnosis of CKD receiving hemodialysis prior to transplant;
- admission for kidney transplant surgery;
- men and women at least 18 year of age;
- one or more plasma PTH values determined during during the 6 months before screening that is greater the 65pg/ml;
- plasma PTH greater than 65pg/ml at screening before kidney transp\[lant as measured by the central lab.
Exclusion
- history of medical conditions that cause hypercalcemia such as primary HPT, active malignancy, and granulomatous diseases.
- receipt of multiple organ transplant.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01163669
Start Date
July 1 2010
End Date
November 1 2012
Last Update
August 13 2013
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195