Renal Allograft Tolerance Through Mixed Chimerism

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT01780454
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MEDI-507 — DRUG
    T-Cell Depleting Agent
  • Rituximab — DRUG
    B-Cell Depleting Agent
  • Total Body Irradiation — RADIATION
    Bone Marrow Depletion
  • Thymic Irradiation — RADIATION

Study Details

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

Key Dates

Start date
Mar 31, 2013
Status verified
Mar 2021
Primary completion
Jun 30, 2018
Completion
Jun 30, 2020

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Successful Withdrawal of Immunosuppressive Therapy [ Time Frame: 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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