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CompletedNCT01163669Updated Aug 13, 2013

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

An observational study in Hyperparathyroidism, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-13.

Sponsored by The Cleveland Clinic · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Hyperparathyroidism

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Keywords

  • hyperparathyroidism
03

In context

Hyperparathyroidism

305 studies on the registry are indexed under Hyperparathyroidism; 23 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 88 observational studies indexed under Hyperparathyroidism.

Browse Hyperparathyroidism studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

kidney transplant recipients

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

Exclusion Criteria:

  • history of medical conditions that cause hypercalcemia such as primary HPT, active malignancy, and granulomatous diseases.
  • receipt of multiple organ transplant.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)

Groups and cohorts

  • kidney transplant recipients
06

What researchers measure

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

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Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01163669
Lead sponsor
The Cleveland Clinic
Collaborators
Amgen
Responsible party
Sponsor
First posted
Jul 16, 2010
Start date
Jul 2010
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Aug 13, 2013

Study contacts

T Srinivas, MD, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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