Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001859
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
1999-11-03
Brief Title:
Screening for Patients Needing Kidney Kidney-Pancreas or Islet-Cell Transplant
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening Protocol for Patients Needing a Kidney Kidney-Pancreas or Islet Cell Transplant
Status:
COMPLETED
Status Verified Date:
2014-05-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
This protocol is designed for screening of patients with renal failure andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-DK-0120 | None | None | None |