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

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01163669
First received: July 14, 2010
Last updated: August 12, 2013
Last verified: January 2012
  Purpose

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.


Condition
Hyperparathyroidism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study to Describe the Evolution of Persistent Hyperparathyroidism in Kidney Transplant Recipients

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • plasma parathyroid hormone(PTH)level [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • corrected total serum calcium and phosphorus concentration [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: July 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
kidney transplant recipients

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

kidney transplant recipients

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163669

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Amgen
Investigators
Principal Investigator: T Srinivas, MD, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01163669     History of Changes
Other Study ID Numbers: 20080093
Study First Received: July 14, 2010
Last Updated: August 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
hyperparathyroidism

Additional relevant MeSH terms:
Hyperparathyroidism
Endocrine System Diseases
Parathyroid Diseases

ClinicalTrials.gov processed this record on October 20, 2014