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

July 14, 2010
August 12, 2013
July 2010
November 2012   (final data collection date for primary outcome measure)
plasma parathyroid hormone(PTH)level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01163669 on ClinicalTrials.gov Archive Site
corrected total serum calcium and phosphorus concentration [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Prospective Cohort Study to Describe the Evolution of Persistent Hyperparathyroidism in Kidney Transplant Recipients
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

kidney transplant recipients

Hyperparathyroidism
Not Provided
kidney transplant recipients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01163669
20080093
No
The Cleveland Clinic
The Cleveland Clinic
Amgen
Principal Investigator: T Srinivas, MD, MD The Cleveland Clinic
The Cleveland Clinic
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP