A Prospective Cohort Study to Describe the Evolution of Persistent Hyperparathyroidism in Kidney Transplant Recipients
Completed
Conditions studied: Hyperparathyroidism
In brief
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.
Key facts
- Study ID
- NCT01163669
- Run by
- The Cleveland Clinic
- People needed
- 15
- Starts
- 2010-07-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2013-08-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- history of medical conditions that cause hypercalcemia such as primary HPT, active malignancy, and granulomatous diseases.
- receipt of multiple organ transplant.
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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