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

NCT01163669 | Completed

• 1 other identifier: 20080093
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperparathyroidism

Keywords

hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• plasma parathyroid hormone(PTH)level

  12 months

Secondary Outcomes (1)

• corrected total serum calcium and phosphorus concentration

  12 months

Study Arms (1)

kidney transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

kidney transplant recipients

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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Amgen: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• T Srinivas, MD, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 13, 2013

Record last verified: 2012-01

Locations

US (1)