Combined Kidney and Bone Marrow Transplantation to Prevent Kidney Transplant Rejection

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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All patients receiving an organ or tissue transplant must take special medicines known as "immunosuppressive drugs" in order to prevent the immune system from rejecting the transplant. These drugs can be very effective, but they leave the patient at an increased risk of serious infections and certain types of cancer. New methods of preventing transplant rejection are needed.

Researchers have found that transplanting both bone marrow and a kidney from the same donor can create what is called "mixed chimerism." This means that the transplant recipient has a mixture of the donor and recipient's immune systems. It is believed that this mixture of immune cells can prevent rejection of the kidney. In a small prior study, performing a kidney transplant together with a bone marrow transplant from the same donor allowed 4 of 5 patients to stop taking immunosuppressive drugs altogether, without rejecting their transplant. This clinical trial will study more patients to confirm if the technique is safe and effective.

Patients eligible for this study must be candidates for a living kidney transplant, and have an eligible donor identified. The transplant recipient and donor must both consent to participate in this study. Transplant recipients enrolled in the study will receive both kidney and bone marrow transplants from the same living donor. Prior to the transplant procedure, the transplant recipient will undergo a "conditioning regimen" that prepares their immune system for the recipient's immune (bone marrow) cells. This conditioning regimen is a combination of chemotherapy, radiation, immunosuppressive drugs and specialized medications called rituximab and MEDI-507. MEDI-507 is an investigational medication that has not been approved by the FDA. After the transplant procedure, transplant recipients will be prescribed steroids for several weeks and immunosuppressive drugs. After 2 months, the dose of the immunosuppressive drugs will slowly be decreased to zero in patients whose immune system and kidney function meet certain criteria.

Transplant recipients enrolled into the study will be hospitalized for 1 week prior to the transplant procedure. After the transplant, patients will remain in the hospital until the doctor feels they are well enough to go home. Recipients will receive approximately monthly checkups over a period of 2 years after transplant, plus a checkup at 2 ½, 3, 3 ½ , 4, and 5 years after transplant. Checkups will include physical exams, and blood and urine tests to assess immune system and kidney function. At four of these checkups, a kidney biopsy will be requested.

Transplant donors enrolled in the study will attend a screening visit, which will include a physical exam, blood tests and chest x-ray. Eligible donors will be admitted to the hospital for 3-5 days, where bone marrow will be collected prior to removal of the kidney. Transplant donors may be asked at a later date to donate additional blood samples for research purposes.

Conditions

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Kidney Transplantation Kidney Failure, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Kidney and Marrow Recipients

Combined kidney and bone marrow transplant

Group Type EXPERIMENTAL

Kidney Transplantation

Intervention Type PROCEDURE

Surgical transplantation of donor kidney

Bone marrow transplantation

Intervention Type 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

Intervention Type BIOLOGICAL

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

cyclophosphamide

Intervention Type DRUG

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

rituximab

Intervention Type BIOLOGICAL

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

Tacrolimus

Intervention Type 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

Intervention Type 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

Intervention Type RADIATION

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

Interventions

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Kidney Transplantation

Surgical transplantation of donor kidney

Intervention Type 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

Intervention Type PROCEDURE

MEDI-507

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

Intervention Type BIOLOGICAL

cyclophosphamide

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

Intervention Type DRUG

rituximab

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

Intervention Type BIOLOGICAL

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

Intervention Type 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

Intervention Type DRUG

thymic irradiation

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

Intervention Type RADIATION

Other Intervention Names

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Renal Transplantation siplizumab anti-CD2 monoclonal antibody Cytoxan Rituxan PROGRAF® methylprednisolone prednisone

Eligibility Criteria

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Inclusion Criteria

* Awaiting first or second transplant with a living donor or first transplant with a cadaveric donor
* For living-donor transplants, must have one or more HLA antigen-mismatched donors identified
* Serologic evidence of prior exposure to Epstein-Barr virus (EBV)

Exclusion Criteria

* ABO blood group-incompatibility for a kidney graft of tissue from a donor
* Decreased circulating white blood cell count
* Positive for HIV-1, hepatitis B and C viruses
* Have had prior radiation therapy that could limit dose
* Lung capacity \<50% of predicted normal
* Evidence of insufficient cardiac capacity
* Unwilling to use adequate contraception until 2 years after transplant
* Lactation or pregnancy
* Presence of antibody against the donor

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No