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

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

621 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-06-04

Study Completion Date

2014-05-30

Brief Summary

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

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.

...

Detailed Description

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

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.

Conditions

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

Diabetes Mellitus Kidney Failure

Keywords

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

Evaluation Diabetes Renal Failure

Eligibility Criteria

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

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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

Monique E Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 20943783 (View on PubMed)

Other Identifiers

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

99-DK-0120

Identifier Type: -

Identifier Source: secondary_id

990120