Renal Allograft Tolerance Through Mixed Chimerism

This study is currently recruiting participants.

Verified May 2013 by Massachusetts General Hospital

Sponsor:

Information provided by (Responsible Party):

David Sachs M.D., Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01780454

First received: January 29, 2013

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 29, 2013

Last Updated Date

May 6, 2013

Start Date ^ICMJE

March 2013

Estimated Primary Completion Date

August 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Successful withdrawal of immunosuppressive therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01780454 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of Engraftment Syndrome [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Renal Allograft Tolerance Through Mixed Chimerism

Official Title ^ICMJE

Renal Allograft Tolerance Through Mixed Chimerism

Brief Summary

This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related donor. An investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

End Stage Renal Disease

Intervention ^ICMJE

Drug: MEDI-507
T-Cell Depleting Agent
Drug: Rituximab
B-Cell Depleting Agent
Radiation: Total Body Irradiation
Bone Marrow Depletion
Radiation: Thymic Irradiation

Study Arm (s)

Experimental: Combined Bone Marrow and Kidney Transplantation

Conditioning regimen consisting of Rituximab, MEDI-507, Total Body Irradiation, Thymic Irradiation followed by simultaneous bone marrow and kidney transplantation

Interventions:

Drug: MEDI-507
Drug: Rituximab
Radiation: Total Body Irradiation
Radiation: Thymic Irradiation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

August 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Key Inclusion Criteria:

Male or female 18-60 years of age
Candidate for a living-donor renal allograft with a one haplotype identical donor identified.
First or second transplant with either a living donor or cadaveric transplant as the first transplant.
Positive serologic testing for EBV indicating past exposure.

Key Exclusion Criteria:

ABO blood group-incompatible renal allograft.
Evidence of anti-HLA antibody within 60 days prior to transplant as assessed by routine methodology (AHG and/or ELISA)
Positive testing for: HIV, hepatitis B core antigen, or hepatitis C virus or positivity for hepatitis B surface antigen.
Cardiac ejection fraction < 40% or clinical evidence of insufficiency.
History of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type I or II nonproliferative glomerulonephritis).
Prior dose-limiting radiation therapy.
Abnormal (>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT).
The presence of any medical condition that the investigator deems incompatible with participation in the trial.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Kerry Crisalli, RN

617-643-4087

kcrisalli@partners.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01780454

Other Study ID Numbers ^ICMJE

2013P000822

Has Data Monitoring Committee

Responsible Party

David Sachs M.D., Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	A. Benedict Cosimi, M.D.	Massachusetts General Hospital
Principal Investigator:	David Sachs, M.D.	Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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