Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02314403
Phase
PHASE1
Status
Completed

Conditions

  • Kidney Failure, Chronic
  • Renal Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Belatacept — DRUG
    A selective T-cell (lymphocyte) costimulation blocker
  • ATG — DRUG
    A T-Cell Depleting Agent
  • Rituximab — DRUG
    B-Cell Depleting Agent
  • Total Body Irradiation — RADIATION
  • Thymic Irradiation — RADIATION
  • Combined Bone Marrow/Kidney Transplantation — PROCEDURE

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
Feb 28, 2015
Status verified
Oct 2021
Primary completion
Mar 31, 2021
Completion
Jul 31, 2021

Study Design

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

Arms

  • Experimental: Combined Bone Marrow and Kidney Transplantation
    Recipients will receive a conditioning regimen that starts with Rituximab on day -7 (and days -2, 5, 12), Whole Body Irradiation 1.5 Gy x2 on study days -6 and -5, followed by ATG on Days -2, -1, 0. Belatacept 10mg/kg on Days 0, 3, 10, 17, 24, 38, 52. Thymic irradiation (7 Gy) will be given on study day -1, and combined renal and bone marrow transplant will be done on study day 0. Prednisone will be started at 2 mg/kg on day 4 and tapered off by day 20. Tacrolimus will be administered on study days -1 through 60, and then tapered if weaning criteria are met.

Primary Outcome Measure

Number of Participants With Successful Withdrawal of Immunosuppression [ Time Frame: 5 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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By research site
Massachusetts General Hospital· Boston, MA

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