ClinicalTrials.gov

History of Changes for Study: NCT00001859
Screening for Patients Needing Kidney, Kidney-Pancreas, or Islet-Cell Transplant
Latest version (submitted December 14, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 June 19, 2006 Study Status, Contacts/Locations, Eligibility, References, Study Design, Study Description, Oversight and Study Identification
3 August 23, 2006 Contacts/Locations and Study Status
4 August 29, 2006 Study Design and Study Status
5 October 26, 2006 Eligibility and Study Status
6 December 12, 2006 Study Status and Contacts/Locations
7 February 24, 2007 Study Status
8 April 27, 2007 Study Status
9 June 8, 2007 Study Status
10 October 19, 2007 Outcome Measures, Study Design and Study Status
11 October 26, 2007 Outcome Measures and Study Status
12 March 3, 2008 Study Status
13 March 7, 2008 Study Status
14 March 19, 2008 Recruitment Status, Study Status, Contacts/Locations, References and Eligibility
15 March 21, 2008 Study Status
16 July 18, 2008 Study Status
17 September 19, 2008 Recruitment Status and Study Status
18 March 6, 2009 Study Status
19 August 24, 2009 Study Status and Study Design
20 November 25, 2009 Study Design and Study Status
21 February 26, 2010 Study Status
22 June 16, 2010 Study Status
23 July 7, 2010 Study Status
24 September 17, 2010 References and Study Status
25 March 2, 2011 Study Status
26 December 24, 2011 Study Status
27 February 28, 2012 Study Status
28 March 14, 2012 Contacts/Locations and Study Status
29 March 21, 2012 Study Status
30 May 30, 2012 Recruitment Status and Study Status
31 May 31, 2012 Recruitment Status and Study Status
32 December 15, 2012 Study Status
33 December 22, 2012 Study Status
34 February 5, 2013 Study Status
35 February 6, 2013 Study Status
36 May 1, 2013 Study Status
37 February 15, 2014 Study Status
38 February 19, 2014 Study Status
39 March 14, 2014 Study Status
40 May 31, 2014 Study Status and References
41 January 19, 2017 Study Status
42 January 20, 2017 Study Status
43 January 24, 2017 Study Status
44 April 19, 2017 Study Status
45 June 30, 2017 Study Status
46 October 5, 2017 Study Status
47 February 13, 2018 Study Description and Study Status
48 February 14, 2018 Study Description and Study Status
49 February 16, 2018 Study Description and Study Status
50 February 22, 2018 Study Description and Study Status
51 February 27, 2018 Study Description and Study Status
52 February 28, 2018 Study Description and Study Status
53 March 2, 2018 Study Description and Study Status
54 March 3, 2018 Study Description and Study Status
55 March 7, 2018 Study Description and Study Status
56 March 9, 2018 Study Description and Study Status
57 March 14, 2018 Study Description and Study Status
58 March 17, 2018 Study Description and Study Status
59 March 22, 2018 Study Description and Study Status
60 March 31, 2018 Study Description and Study Status
61 April 3, 2018 Study Description and Study Status
62 April 5, 2018 Study Description and Study Status
63 April 18, 2018 Study Description and Study Status
64 April 19, 2018 Study Description and Study Status
65 April 21, 2018 Study Description and Study Status
66 April 26, 2018 Study Description and Study Status
67 April 28, 2018 Study Description and Study Status
68 May 5, 2018 Study Description and Study Status
69 May 11, 2018 Study Description and Study Status
70 May 15, 2018 Study Description and Study Status
71 May 16, 2018 Study Description and Study Status
72 May 18, 2018 Study Description and Study Status
73 June 15, 2018 Study Description and Study Status
74 June 19, 2018 Study Description and Study Status
75 July 13, 2018 Study Description and Study Status
76 July 20, 2018 Study Description and Study Status
77 July 27, 2018 Study Description and Study Status
78 July 28, 2018 Study Description and Study Status
79 July 31, 2018 Study Description and Study Status
80 August 2, 2018 Study Description and Study Status
81 August 4, 2018 Study Description and Study Status
82 August 7, 2018 Study Description and Study Status
83 August 9, 2018 Study Description and Study Status
84 August 11, 2018 Study Description and Study Status
85 August 14, 2018 Study Description and Study Status
86 August 16, 2018 Study Description and Study Status
87 August 18, 2018 Study Description and Study Status
88 August 22, 2018 Study Description and Study Status
89 September 1, 2018 Study Description and Study Status
90 September 8, 2018 Study Description and Study Status
91 September 12, 2018 Study Description and Study Status
92 September 15, 2018 Study Description and Study Status
93 October 3, 2018 Study Description and Study Status
94 October 11, 2018 Study Description and Study Status
95 October 26, 2018 Study Description and Study Status
96 October 30, 2018 Study Description and Study Status
97 October 31, 2018 Study Description and Study Status
98 November 1, 2018 Study Description and Study Status
99 November 2, 2018 Study Description and Study Status
100 November 3, 2018 Study Description and Study Status
101 November 8, 2018 Study Description and Study Status
102 November 14, 2018 Study Description and Study Status
103 November 15, 2018 Study Description and Study Status
104 November 16, 2018 Study Description and Study Status
105 December 1, 2018 Study Description and Study Status
106 December 4, 2018 Study Description and Study Status
107 December 5, 2018 Study Description and Study Status
108 December 8, 2018 Study Description and Study Status
109 December 19, 2018 Study Description and Study Status
110 December 22, 2018 Study Description and Study Status
111 December 29, 2018 Study Description and Study Status
112 January 4, 2019 Study Description and Study Status
113 January 5, 2019 Study Description and Study Status
114 January 9, 2019 Study Description and Study Status
115 January 10, 2019 Study Description and Study Status
116 January 12, 2019 Study Description and Study Status
117 January 18, 2019 Study Description and Study Status
118 January 24, 2019 Study Description and Study Status
119 February 8, 2019 Study Description and Study Status
120 February 14, 2019 Study Description and Study Status
121 March 9, 2019 Study Description and Study Status
122 March 15, 2019 Study Description and Study Status
123 March 16, 2019 Study Description and Study Status
124 March 19, 2019 Study Description and Study Status
125 March 28, 2019 Study Description and Study Status
126 April 2, 2019 Study Description and Study Status
127 April 9, 2019 Study Description and Study Status
128 April 10, 2019 Study Description and Study Status
129 April 11, 2019 Study Description and Study Status
130 April 19, 2019 Study Description and Study Status
131 April 23, 2019 Study Description and Study Status
132 April 24, 2019 Study Description and Study Status
133 April 30, 2019 Study Description and Study Status
134 May 2, 2019 Study Description and Study Status
135 May 7, 2019 Study Description and Study Status
136 May 10, 2019 Study Description and Study Status
137 May 21, 2019 Study Description and Study Status
138 May 24, 2019 Study Description and Study Status
139 May 31, 2019 Study Description and Study Status
140 June 5, 2019 Study Description and Study Status
141 June 25, 2019 Study Description and Study Status
142 June 26, 2019 Study Description and Study Status
143 June 28, 2019 Study Description and Study Status
144 June 29, 2019 Study Description and Study Status
145 July 2, 2019 Study Description and Study Status
146 July 3, 2019 Study Description and Study Status
147 July 4, 2019 Study Description and Study Status
148 July 6, 2019 Study Description and Study Status
149 July 12, 2019 Study Description and Study Status
150 July 13, 2019 Study Description and Study Status
151 July 24, 2019 Study Description and Study Status
152 July 30, 2019 Study Description and Study Status
153 August 3, 2019 Study Description and Study Status
154 August 13, 2019 Study Description and Study Status
155 September 4, 2019 Study Description and Study Status
156 September 5, 2019 Study Description and Study Status
157 September 28, 2019 Study Description and Study Status
158 October 8, 2019 Study Description and Study Status
159 October 18, 2019 Study Description and Study Status
160 October 22, 2019 Study Description and Study Status
161 October 24, 2019 Study Description and Study Status
162 October 29, 2019 Study Description and Study Status
163 November 19, 2019 Study Description and Study Status
164 November 20, 2019 Study Description and Study Status
165 November 22, 2019 Study Description and Study Status
166 November 27, 2019 Study Description and Study Status
167 December 6, 2019 Study Description and Study Status
168 December 11, 2019 Study Description and Study Status
169 December 14, 2019 Study Description and Study Status
Comparison Format:

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Study NCT00001859
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: 990120
Brief Title: Screening for Patients Needing Kidney, Kidney-Pancreas, or Islet-Cell Transplant
Official Title: Screening Protocol for Patients Needing a Kidney, Kidney-Pancreas, or Islet Cell Transplant
Secondary IDs: 99-DK-0120
Open or close this module Study Status
Record Verification: May 22, 2006
Overall Status: Recruiting
Study Start: June 4, 1999
Primary Completion:
Study Completion:
First Submitted: November 3, 1999
First Submitted that
Met QC Criteria:
November 3, 1999
First Posted: November 4, 1999 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Diabetes Mellitus
Kidney Failure
Keywords: Evaluation
Diabetes
Renal Failure
Open or close this module Study Design
Study Type: Observational
Time Perspective:
Biospecimen Retention:
Biospecimen Description:
Enrollment: 999
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
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.Inbility 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.
Open or close this module Contacts/Locations
Locations: United States, Maryland
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
[Recruiting]
Bethesda, Maryland, United States, 20892
Contact:Contact: Patient Recruitment and Public Liaison Office 8004111222 prpl@mail.cc.nih.gov
Contact:Contact: TTY 1-866-411-1010
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Detailed Web Page
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services