Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

Status:	Active, not recruiting
Conditions:	Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:	Nephrology / Urology
Healthy:	No
Age Range:	18 - 65
Updated:	12/9/2018
Start Date:	March 2008
End Date:	March 2031

Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell
Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood
elements, help fight infection and assist in clotting) and kidney transplantation from the
same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired
result of this study is to allow your body to develop "tolerance" to the transplanted kidney.
Tolerance means that your body would see the transplanted kidney as part of you and not try
to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must
be taken on a daily basis. The purpose of this study is to determine if this procedure is
safe and to try to substantially reduce or even eliminate the need for anti-rejection
medications.

Inclusion Criteria:

- Patient must be between the ages of 18 and 65 years and meet the institution's
criteria for renal transplantation for end-organ failure

- Meets the transplant criteria by the study site and both the recipient and donor have
been accepted as candidates for standard of care living kidney donation and
transplantation

- Patient is receiving a renal transplant only

- The crossmatch is negative between donor and recipient. An initial crossmatch will be
performed prior to stem cell mobilization to determine if subject can proceed with the
pheresis.

- Potential recipients who are women of child bearing potential must have a negative
pregnancy test (urine test is acceptable) within 48 hours prior to receiving
Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception
for 1 year following FCRx infusion

- Potential donors who are women of child bearing potential must have a negative
pregnancy test (urine test is acceptable) within 48 hours prior to receiving G-CSF

- No evidence of donor-specific antibody presently or historically

- Panel Reactive Antibody (PRA) less than or equal to 20

Note: The subjects do not need to be local residents in order to be eligible for this
trial, but must be willing to reside in the area, or within a four hour drive, for the
first month of the protocol so that we can monitor them closely in the early post
transplant period. As long as there is insurance or funding that will cover the cost of the
transplant and any research related complications, it is not necessary for the subjects to
be US citizens to participate in this trial.

Exclusion Criteria:

- Clinically active bacterial, fungal, viral or parasitic infection

- Pregnancy

- Clinical or serologic evidence of viral infection which would preclude the recipient
from receiving a kidney transplant or FCRx infusion

- Previous radiation therapy at a dose which would preclude Total Body Irradiation (TBI)

- Positive crossmatch between donor and recipient

- Evidence for immunologic memory against donor

- BMI >35 or <18

- Positive serologies for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), human
immunodeficiency virus (HIV)

- Insufficient funds for the bone marrow processing costs

We found this trial at

sites

Northwestern Memorial Hospital

251 E Huron St
Chicago, Illinois 60611

(312) 926-2000