Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients

This study has been completed.

Sponsor:

Collaborator:

Immune Tolerance Network (ITN)

Information provided by (Responsible Party):

George W. Burke, National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00183248

First received: September 11, 2005

Last updated: September 17, 2012

Last verified: September 2012

History of Changes

Results First Received: April 5, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Conditions:	Kidney Transplantation Kidney Disease Kidney Failure
Interventions:	Drug: Alemtuzumab Drug: Mycophenolate mofetil Drug: Sirolimus Drug: Tacrolimus Procedure: Donor bone marrow stem cell infusion Procedure: Kidney transplant

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
One center in the United States enrolled nine subjects who were recipients of living-related (1-haplotype-matched) donor kidney transplants between September 2004 and November 2006.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants underwent procedures at screening to establish inclusion/exclusion criteria.

Reporting Groups

Description

DBMCs

Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.

Control Group

Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.

Participant Flow: Overall Study

	DBMCs	Control Group
STARTED	4	5
COMPLETED	3	4
NOT COMPLETED	1	1
Lost to Follow-up	0	1
Focal glomerulosclerosis proteinuria	1	0

Baseline Characteristics

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Reporting Groups

	Description
DBMCs	Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
Control Group	Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
Total	Total of all reporting groups

Baseline Measures

	DBMCs	Control Group	Total
Number of Participants [units: participants]	4	5	9
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	4	5	9
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	41.0 ± 12.0	41.8 ± 7.9	41.4 ± 9.7
Gender [units: participants]
Female	2	0	2
Male	2	5	7
Region of Enrollment [units: participants]
United States	4	5	9

Outcome Measures

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1. Primary:

Overall Participant Survival at One Year Post Kidney Transplant [ Time Frame: One year post kidney transplant ]

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2. Primary:

Overall Kidney Graft Survival at One Year Post-Transplant [ Time Frame: One year post kidney transplant ]

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3. Secondary:

Participant Survival at Three Years Post Kidney Transplant [ Time Frame: Three years post kidney transplant ]

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4. Secondary:

Graft Survival at Three Years Post-Transplant [ Time Frame: Three years post kidney transplant ]

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5. Secondary:

Number of Kidney Biopsy-proven Acute Rejection [ Time Frame: Three years post kidney transplant ]

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6. Secondary:

Number of Chronic Allograft Nephropathies [ Time Frame: Three years post kidney transplant ]

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7. Secondary:

Number of Graft-versus-host Disease (GVHD) Events [ Time Frame: Three years post kidney transplant ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In July 2007 after the trial had been enrolling for approximately 42 months, enrollment was stopped at the current number of nine subjects due to time and resource constraints.

Results Point of Contact:

Name/Title: George W. Burke III, M.D.
Organization: University of Miami
phone: (305) 355-5060
e-mail: Gburke@med.miami.edu

No publications provided

Responsible Party:	George W. Burke, National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00183248 History of Changes
Other Study ID Numbers:	DAIT ITN022ST
Study First Received:	September 11, 2005
Results First Received:	April 5, 2012
Last Updated:	September 17, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

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