A Prospective Cohort Study to Describe the Evolution of Persistent Hyperparathyroidism in Kidney Transplant Recipients

NCT ID: NCT01163669

Last Updated: 2013-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-11-30

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.

Conditions

Hyperparathyroidism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

kidney transplant recipients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• history of medical conditions that cause hypercalcemia such as primary HPT, active malignancy, and granulomatous diseases.
• receipt of multiple organ transplant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

T Srinivas, MD, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

20080093

Identifier Type: -

Identifier Source: org_study_id