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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

Tracking Information
First Submitted Date  ICMJE January 29, 2013
First Posted Date  ICMJE January 31, 2013
Results First Submitted Date  ICMJE September 1, 2020
Results First Posted Date  ICMJE September 23, 2020
Last Update Posted Date April 19, 2021
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
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"
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Successful Withdrawal of Immunosuppressive Therapy [ Time Frame: 3 years ]
The primary endpoint is induction of transient mixed chimerism and renal allograft tolerance without "engraftment syndrome" or "acute kidney injury"
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2021)
Number of Participants With Engraftment Syndrome [ Time Frame: 5 Years ]
Constellation of symptoms known "Engraftment Syndrome"
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2013)
Incidence of Engraftment Syndrome [ Time Frame: 3 Years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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 Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2013)
2
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2020
Actual Primary Completion Date June 2018   (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01780454
Other Study ID Numbers  ICMJE 2013P000822
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account Massachusetts General Hospital
Verification Date March 2021

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