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Trial record 1 of 2 for:    david sachs
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Renal Allograft Tolerance Through Mixed Chimerism

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ClinicalTrials.gov Identifier: NCT01780454
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : September 23, 2020
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
David Sachs M.D., Massachusetts General Hospital

Study Description
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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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Allograft Tolerance Through Mixed Chimerism
Study Start Date : March 2013
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2020

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Successful Withdrawal of Immunosuppressive Therapy [ Time Frame: 5 years ]
    The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"


Secondary Outcome Measures :
  1. Number of Participants With Engraftment Syndrome [ Time Frame: 5 Years ]
    Constellation of symptoms known "Engraftment Syndrome"


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01780454


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: A. Benedict Cosimi, M.D. Massachusetts General Hospital
Principal Investigator: David Sachs, M.D. Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by David Sachs M.D., Massachusetts General Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] January 27, 2014

More Information
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Publications:

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Responsible Party: David Sachs M.D., Director, Transplantation Biology Research Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01780454    
Other Study ID Numbers: 2013P000822
First Posted: January 31, 2013    Key Record Dates
Results First Posted: September 23, 2020
Last Update Posted: April 19, 2021
Last Verified: March 2021
Keywords provided by David Sachs M.D., Massachusetts General Hospital:
End Stage Renal Disease
Renal Transplant
Bone Marrow Transplant
 Tolerance
Chimerism
ESRD
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Rituximab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents