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

NCT00001859 | Completed

• 2 other identifiers: 99012099-DK-0120
• Study Type: observational
• Target: 621
• Locations: 1 country
• Sites: 1

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. ...

Conditions

Diabetes Mellitus; Kidney Failure

Keywords

Evaluation; Diabetes; Renal Failure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Peacock M, Bilezikian JP, Bolognese MA, Borofsky M, Scumpia S, Sterling LR, Cheng S, Shoback D. Cinacalcet HCl reduces hypercalcemia in primary hyperparathyroidism across a wide spectrum of disease severity. J Clin Endocrinol Metab. 2011 Jan;96(1):E9-18. doi: 10.1210/jc.2010-1221. Epub 2010 Oct 13.

  PMID: 20943783 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Monique E Cho, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: June 4, 1999
• Study Completion: May 30, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-05-30

Locations

US (1)