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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperparathyroidism

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hyperparathyroidism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

kidney transplant recipients

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

T Srinivas, MD, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20080093

Identifier Type: -

Identifier Source: org_study_id