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

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.

Study Overview

• Status: Completed
• Conditions: Hyperparathyroidism

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

kidney transplant recipients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
kidney transplant recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
plasma parathyroid hormone(PTH)level	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
corrected total serum calcium and phosphorus concentration	12 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Amgen
• Investigators: Principal Investigator: T Srinivas, MD, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: July 15, 2010
• First Posted (Estimate): July 16, 2010

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 12, 2013
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: hyperparathyroidism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Parathyroid Diseases; Hyperparathyroidism
• Other Study ID Numbers: 20080093