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

This study has been completed.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001859
  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

MedlinePlus related topics:   Diabetes    Islet Cell Transplantation    Kidney Failure   

Drug Information available for:   Pancrelipase    Ultrase   

U.S. FDA Resources

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

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

Study Start Date:   June 1999

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

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
  More Information


NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   990120, 99-DK-0120
First Received:   November 3, 1999
Last Updated:   September 19, 2008
ClinicalTrials.gov Identifier:   NCT00001859
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Kidney Diseases
Metabolic disorder
Glucose Metabolism Disorders
Pancrelipase
Kidney Failure

ClinicalTrials.gov processed this record on November 30, 2008




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