Renal Allograft Tolerance Through Mixed Chimerism

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: September 17, 2014
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
End Stage Renal Disease
Drug: MEDI-507
Drug: Rituximab
Radiation: Total Body Irradiation
Radiation: Thymic Irradiation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Allograft Tolerance Through Mixed Chimerism

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Successful withdrawal of immunosuppressive therapy [ Time Frame: 5 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"


Secondary Outcome Measures:
  • Incidence of Engraftment Syndrome [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2
Study Start Date: March 2013
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: MEDI-507
T-Cell Depleting Agent
Drug: Rituximab
B-Cell Depleting Agent
Radiation: Total Body Irradiation
Bone Marrow Depletion
Radiation: Thymic Irradiation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780454

Contacts
Contact: Kerry Crisalli, RN 617-643-4087 kcrisalli@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: A. Benedict Cosimi, M.D. Massachusetts General Hospital
Principal Investigator: David Sachs, M.D. Massachusetts General Hospital
  More Information

Publications:
Responsible Party: David Sachs M.D., Director, Transplantation Biology Research Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01780454     History of Changes
Other Study ID Numbers: 2013P000822
Study First Received: January 29, 2013
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
End Stage Renal Disease
Renal Transplant
Bone Marrow Transplant
Tolerance
Chimerism
ESRD

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014