Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00801632
Phase
PHASE2
Status
Completed

Conditions

  • Kidney Failure, Chronic
  • Kidney Transplantation

Eligibility Criteria

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

Interventions

  • Kidney Transplantation — PROCEDURE
    Surgical transplantation of donor kidney
  • Bone marrow transplantation — PROCEDURE
    During kidney transplant, bone marrow cells donated by the same donor as the kidney are given through a plastic tube placed in a vein in the chest, underneath the collarbone
  • MEDI-507 — BIOLOGICAL
    0.1 mg/kg on day -2; 0.6 mg/kg on days -1,0,1
  • cyclophosphamide — DRUG
    60 mg/kg infusion on days -5, -4
  • rituximab — BIOLOGICAL
    375 mg/m\^2 infusion on days -7, -2, 5, and 12
  • Tacrolimus — DRUG
    0.05 mg/kg intravenously twice daily starting on day -1, adjusted to trough level of 10-15ng/ml, then tapered (if eligible) on days 1, 7, 14, 21, 28, 42, and 56
  • corticosteroids — DRUG
    2 mg/kg prednisone on day 4, with an additional 500-mg pulse of methylprednisolone given on days 10, 11, and 12, and then tapered off by day 20
  • thymic irradiation — RADIATION
    700 cGy of thymic irradiation administered in a single dose on day -1

Study Details

In small initial studies, combined kidney and bone marrow transplants from the same donor have permitted some individuals to stop taking anti-rejection medicines without rejecting their transplant. This clinical trial will study this method in a greater number of people to determine if it is indeed effective and safe.

Key Dates

Start date
Dec 31, 2008
Status verified
Nov 2015
Primary completion
Apr 30, 2014
Completion
Nov 30, 2014

Study Design

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

Arms

  • Experimental: Kidney and Marrow Recipients
    Combined kidney and bone marrow transplant

Primary Outcome Measure

Number of Participants Successfully Withdrawn Off of Immunosuppressant Medication for 104 Weeks [ Time Frame: 48 months post-transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MA

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