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

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ClinicalTrials.gov Identifier: NCT00497926
Recruitment Status : Active, not recruiting
First Posted : July 9, 2007
Last Update Posted : October 18, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Failure Biological: Enriched Hematopoietic Stem Cell Infusion Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
Study Start Date : March 2008
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2031
Arms and Interventions

Arm Intervention/treatment
Experimental: Living Kidney Allograft
Recipients with the need for a living kidney allograft are treated with an enriched hematopoietic stem cell infusion from the same living donor
Biological: Enriched Hematopoietic Stem Cell Infusion
Enriched Hematopoietic Stem Cell Infusion

Outcome Measures

Primary Outcome Measures :
  1. Enriched Hematopoetic Stem Cell Engraftment [ Time Frame: One month to three years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497926

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
University of Louisville
Northwestern University
Regenerex, LLC
Duke University
Principal Investigator: Joseph Leventhal, MD, PhD Northwestern Memorial Hospital
Principal Investigator: Kadiyala Ravindra, MD Duke Unviersity
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00497926     History of Changes
Other Study ID Numbers: ICT-13947-120209
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Louisville:
Kidney transplant
Marrow/Enriched Hematopoetic Stem Cell Transplant

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases