Renal Allograft Tolerance Through Mixed Chimerism

This study is currently recruiting participants.
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: December 12, 2013
Last verified: December 2013

January 29, 2013
December 12, 2013
March 2013
October 2018   (final data collection date for primary outcome measure)
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"
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"
Complete list of historical versions of study NCT01780454 on ClinicalTrials.gov Archive Site
Incidence of Engraftment Syndrome [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
Incidence of Engraftment Syndrome [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
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: 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.
 
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.
Both
18 Years to 65 Years
No
Contact: Kerry Crisalli, RN 617-643-4087 kcrisalli@mgh.harvard.edu
United States
 
NCT01780454
2013P000822
No
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
December 2013

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