Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01163669
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2010-07-14
Brief Title:
A Prospective Cohort Study to Describe the Evolution of Persistent Hyperparathyroidism in Kidney Transplant Recipients
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Prospective Cohort Study to Describe the Evolution of Persistent Hyperparathyroidism in Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 large parathyroid glands in the neck Patients with HPT can develop bone disease osteodystrophy This bone disease can cause bone pain fractures and poor formation of red blood cells Other problems from HPT may include increases in blood levels of calcium hypercalcemia and low blood levels of phosphorus hypophosphatemia The high calcium levels may cause calcium to deposit in body tissues Calcium deposits can cause arthritis joint pain and swelling muscle inflammation itching gangrene death of soft tissue heart and lung problems or kidney transplant dysfunction worsening of kidney transplant function The purpose of this research study is to better understand the evolution of Hpt in people during the first 12 months after receiving a kidney transplant
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 kidney transplantation and at 3 6 9 and 12 months after kidney transplantation During these visits subjects will have a review of medication history blood tests and a kidney function test The blood will be used to test the level of certain components of you blood to see if your HPT has resolved stabilized or advanced At selected visits throughout the study you will have a urine sample collected and a health questionnaire that will ask about your health Information regarding transplant kidney biopsy if performed also will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None