Delayed Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Louisville
Sponsor:
Collaborators:
Northwestern University
Kentucky Science and Technology Corporation
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01649388
First received: June 29, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

This study involves the use of an enriched hematopoetic stem cell infusion (stem cells, produced by the bone marrow) from the same donor who provided the original kidney transplant. This kidney transplant may have taken place months to years previously.


Condition Intervention Phase
Kidney Transplantation
Biological: Hematopoietic Stem Cell Transplant/novel platform technology
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Delayed Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Level of Donor Chimerism from Enriched Hematopoietic Stem Cell Engraftment [ Time Frame: One month to three years ] [ Designated as safety issue: No ]
    Tests are done at key time points to monitor for donor chimerism by evaluating presence of bone marrow-derived hematopoietic stem cells.


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2025 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enriched Hematopoetic Stem Cell Transplant Biological: Hematopoietic Stem Cell Transplant/novel platform technology
Bone marrow will be processed via a new technology which will enrich hematopoietic stem cells and graft facilitating cells. Monitoring for chimerism will be done at key time points.

Detailed Description:

This study 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has received a renal transplant only
  • The original donor for the patient must be willing to participate in the study and meet all of the donor eligibility criteria
  • Patient must be between the ages of 18 and 65 years
  • The crossmatch is negative between donor and recipient within 30 days of the FCRx infusion
  • 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 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% within 30 days of the FCRx infusion

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 stem cell transplant period. As long as there is insurance or funding that will cover the cost of the stem cell 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 an 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
  • Body Mass Index (BMI) greater than 35 or less than 18
  • Positive serologies for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
  • Uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
  • Patients with impaired organ function, such as left ventricular ejection fraction (LVEF) less than 35% or forced expiratory volume at one second (FEV1), forced expiratory volume (FEV), or diffusing capacity of the lung for carbon monoxide (DLCO) less than 50%, or transaminases greater than 4x upper limit of normal be excluded from participation. Biopsy proven rejection episode.
  • Insufficient funds for bone marrow processing costs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649388

Contacts
Contact: Joseph Leventhal, MD 312-695-9019 jleventh@nmh.org

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Dianne Stare    312-694-0240    Dianne.Stare@northwestern.edu   
Principal Investigator: Joseph Leventhal, MD         
Sponsors and Collaborators
University of Louisville
Northwestern University
Kentucky Science and Technology Corporation
Investigators
Principal Investigator: Joseph Leventhal, M.D. Northwestern Memorial Hospital
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01649388     History of Changes
Other Study ID Numbers: ICT-14900-021012, 1R41AI098336-01, KSTC-184-512-12-136
Study First Received: June 29, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Louisville:
Kidney transplant
Delayed tolerance
Marrow/enriched hematopoetic stem cell transplant

ClinicalTrials.gov processed this record on July 24, 2014