Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Two centers in the United States enrolled five recipients of non-human leukocyte antigen (HLA)-identical living-donor-related renal transplants between January 2007 and January 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and sign the informed consent form.

Reporting Groups

	Description
Immunosuppression Withdrawal	Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal

Participant Flow:   Overall Study

	Immunosuppression Withdrawal
STARTED	5
COMPLETED	2
NOT COMPLETED	3
Withdrawal by Subject	3

Reporting Groups

	Description
Immunosuppression Withdrawal	Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal

Baseline Measures

	Immunosuppression Withdrawal
Number of Participants   [units: participants]	5
Age   [units: participants]
<=18 years	0
Between 18 and 65 years	5
>=65 years	0
Age   [units: years] Mean ± Standard Deviation	50.4  ± 5.9
Gender   [units: participants]
Female	3
Male	2
Region of Enrollment   [units: participants]
United States	5

1.  Primary:

Acute Rejection at 6-Months   [ Time Frame: 6 months post-transplant ]

2.  Secondary:

Participant Survival at 12 Months Post-Transplant   [ Time Frame: 12 months post-transplant ]

3.  Secondary:

Acute Rejection at 12-Months   [ Time Frame: 12 months post-transplant ]

4.  Secondary:

Tolerance Induction   [ Time Frame: 48 months ]

5.  Secondary:

Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks   [ Time Frame: 24 weeks post-transplant ]

6.  Secondary:

Graft Survival at 12 Months Post-transplant   [ Time Frame: 12 months post-transplant ]

7.  Secondary:

Time From Transplant to Acute Rejection   [ Time Frame: Transplantation until rejection occurs (participants followed up to four years post-transplantation) ]

8.  Secondary:

Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection   [ Time Frame: Participants followed from transplantation until completion of study (up to four years post-transplantation) ]

9.  Secondary:

Proportion of Participants With Post-transplant Infections   [ Time Frame: Participants followed from transplantation until completion of study (up to four years post-transplantation) ]

10.  Secondary:

Proportion of Participants With Wound Complications   [ Time Frame: Start of study to end of study ]

11.  Secondary:

Proportion of Participants With Malignancies   [ Time Frame: Participants followed from transplantation until completion of study (up to four years post-transplantation) ]

12.  Secondary:

Proportion of Participants With a Sirolimus Associated Adverse Event   [ Time Frame: Participants followed from transplantation until completion of study (up to four years post-transplantation) ]

13.  Secondary:

Proportion of Participants With Chronic Allograft Nephropathy   [ Time Frame: Participants followed from transplantation until completion of study (up to four years post-transplantation) ]

14.  Secondary:

Proportion of Participants With Delayed Graft Function   [ Time Frame: Participants followed from transplantation until completion of study (up to four years post-transplantation) ]

15.  Secondary:

Proportion of Participants With Post-transplant Diabetes Mellitus   [ Time Frame: Participants followed from transplantation until completion of study (up to four years post-transplantation) ]