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Renal Allograft Tolerance Through Mixed Chimerism

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780454
First Posted: January 31, 2013
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Sachs M.D., Massachusetts General Hospital
January 29, 2013
January 31, 2013
April 21, 2017
March 2013
October 2018   (Final data collection date for primary outcome measure)
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"
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"
Complete list of historical versions of study NCT01780454 on ClinicalTrials.gov Archive Site
Incidence of Engraftment Syndrome [ Time Frame: 5 Years ]
Incidence of Engraftment Syndrome [ Time Frame: 3 Years ]
Not Provided
Not Provided
 
Renal Allograft Tolerance Through Mixed Chimerism
Renal Allograft Tolerance Through Mixed Chimerism
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
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
End Stage Renal Disease
  • Drug: MEDI-507
    T-Cell Depleting Agent
  • Drug: Rituximab
    B-Cell Depleting Agent
  • Radiation: Total Body Irradiation
    Bone Marrow Depletion
  • Radiation: Thymic Irradiation
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2
Not Provided
October 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01780454
2013P000822
No
Not Provided
Not Provided
David Sachs M.D., Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: A. Benedict Cosimi, M.D. Massachusetts General Hospital
Principal Investigator: David Sachs, M.D. Massachusetts General Hospital
Massachusetts General Hospital
April 2017

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