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OpenTrials
Completed

NCT Number: NCT01163669

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.

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Key information

Conditions

Hyperparathyroidism Endocrine System Diseases Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. plasma parathyroid hormone(PTH)level

    Time frame: 12 months

Secondary outcomes

  1. corrected total serum calcium and phosphorus concentration

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Amgen

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 16, 2010
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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