Screening for Patients Needing Kidney, Kidney-Pancreas, or Islet-Cell Transplant

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001859
First received: November 3, 1999
Last updated: May 31, 2014
Last verified: May 2014
  Purpose

Kidney transplantation is the preferred treatment for most end-stage kidney disease. This procedure is limited, however, by two major factors: 1) a shortage of donor organs and 2) organ rejection by the recipient. The National Institute of Diabetes and Digestive and Kidney Diseases is screening patients with kidney failure or diabetes who may be eligible for kidney, kidney and pancreas, or islet cell transplantation.

Patients in this screening study are not offered treatment. When the screening is complete, patients will be offered an opportunity to participate in another institute study, or, if there are no active studies appropriate for the patient, other options will be suggested to the primary or referring physician. Patients found eligible for a study are not obligated to participate.

Screening for all patients typically consists of blood tests, urinalysis, electrocardiogram, PPD tuberculosis screen and pregnancy test. Chest and kidney X-rays and other studies may be done on patients determined eligible for a particular study, including transplantation. A summary of all test results will be sent to the referring physician unless the patient requests otherwise.


Condition
Diabetes Mellitus
Kidney Failure

Study Type: Observational
Official Title: Screening Protocol for Patients Needing a Kidney, Kidney-Pancreas, or Islet Cell Transplant

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 621
Study Start Date: June 1999
Estimated Study Completion Date: May 2014
Detailed Description:

This protocol is designed for screening of patients with renal failure and/or diabetes who may be eligible for kidney, kidney-pancreas, or islet cell transplantation. Its purpose is to allow detailed investigation into the renal and endocrine function of these patients, and the status of other organ systems that would determine their ability to safely tolerate specific aspects of other therapeutic research protocols. After completion of this screening process, the patient will either be offered a chance to participate in an active treatment protocol, or if no appropriate protocol is identified, will have recommendations for other treatment options relayed to the primary or referring physicians.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients will be entered on this protocol at the time of their first visit to the NIH Clinical Center Outpatient Clinic or Inpatient Services if:

The patient carries the diagnosis of a disorder for which the Transplant Branch has active research interest, and based on information received from an outside physician, they meet preliminary eligibility criteria for other specific research protocols.

The patient or the patient's guardian is capable of providing informed consent, and signs the informed consent after initial counseling by clinical staff. Separate consent forms for all interventional procedures will be obtained after explanation of the specific procedure.

EXCLUSION CRITERIA:

History of known malignancies except basal cell carcinoma of the skin.

Inability to give legal informed consent by self or legal guardian.

Inability or willingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services, or access to anti-rejection drugs after the research protocol is completed.

  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: NCT00001859

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Monique E Cho, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

No publications provided by National Institutes of Health Clinical Center (CC)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00001859     History of Changes
Other Study ID Numbers: 990120, 99-DK-0120
Study First Received: November 3, 1999
Last Updated: May 31, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Evaluation
Diabetes
Renal Failure

Additional relevant MeSH terms:
Diabetes Mellitus
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014