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Clinical Trials/NCT00001859
NCT00001859
Completed
Not Applicable

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 site in 1 country621 target enrollmentJune 4, 1999

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment
621
Locations
1
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

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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.

Registry
clinicaltrials.gov
Start Date
June 4, 1999
End Date
May 30, 2014
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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