Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection

Summary

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.

Conditions

• Kidney Transplantation
• Kidney Failure, Chronic

Interventions

PROCEDURE

Kidney Transplantation

Surgical transplantation of donor kidney

PROCEDURE

Bone marrow transplantation

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

BIOLOGICAL

MEDI-507

0.1 mg/kg on day -2; 0.6 mg/kg on days -1,0,1

DRUG

cyclophosphamide

60 mg/kg infusion on days -5, -4

BIOLOGICAL

rituximab

375 mg/m\^2 infusion on days -7, -2, 5, and 12

DRUG

Tacrolimus

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

DRUG

corticosteroids

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

RADIATION

thymic irradiation

700 cGy of thymic irradiation administered in a single dose on day -1

Sponsors & Collaborators

• Immune Tolerance Network (ITN)

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• David Sachs, MD · Massacusetts General Hospital

• Ben Cosimi, MD · Massachusetts General Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-12-31

Primary Completion

2014-04-30

Completion

2014-11-30

Countries

• United States

Study Locations