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A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03284242
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : October 3, 2019
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Roberto Gedaly, University of Kentucky

Brief Summary:

This study will enroll individuals who have end stage renal disease and who are undergoing a solitary kidney transplant. This study is investigating/evaluating the safety and effectiveness of collecting, expanding and infusing a specific certain type of immune cell known as Regulatory T cells (Treg cells) to renal transplant recipients who are using Zortress (Everolimus) as immunosuppressive therapy.

Treg cells, once they have been expanded in the laboratory to help prevent kidney rejection. Treg cells are collected from a participant's blood through a procedure called apheresis. Treg cells are a type of white blood cells that are able to suppress the activity of other immune cells responsible for organ rejection. The investigator plans to enroll 12 participants at the University of Kentucky.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Kidney Transplant Procedure: Apheresis Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single intravenous infusion of autologous, ex vivo, expanded Treg cells in renal transplant recipients who are on Everolimus-based immunosupressive therapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolerance Induction Using Autologous Regulatory T Cell Infusion and Zortress (Everolimus) in Renal Transplant Recipients: a Pilot Study
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
Experimental: Autologous Treg Infusion
This will be a single intravenous (IV) infusion. A participant's own expanded regulatory T cells will be added to Albumin, and administered to them. The amount of the solution will be approximately 300 ml and the infusion will take about 3 to 4 hours.
Procedure: Apheresis
Collect white blood cells to isolate Treg cells for expansion. Once the blood cells are collected the cells will be cultured in the laboratory and will be expanded. After approximately 3 weeks in culture, the cells will have increased in number and be ready for the autologous Treg cell infusion.

Primary Outcome Measures :
  1. Changes in Tregs Infusion Toxicities [ Time Frame: Immediately following Tregs infusion and again within 24 hours after Tregs infusion ]
    Laboratory measurement and observed toxicities immediately and with in 24 hours post infusion of Tregs.

  2. Changes in Kidney Function [ Time Frame: for 2 years from the start of the study ]
    Creatinine level measurement

  3. Changes In Steroid Resistance Rejection Rates [ Time Frame: 1, 6 and 12 months post Tregs infusion ]
    Laboratory measurement

  4. Infectious Complications [ Time Frame: for 2 years from the start of the study ]
    Laboratory measurement

Secondary Outcome Measures :
  1. Treg cell measurements within the allograft [ Time Frame: 6 to 12 weeks post transplant ]
    Renal biopsy

  2. Circulating T cell subset measurements [ Time Frame: twice a week for 4 weeks then weekly for 3 months ]
    laboratory analysis

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Fluent in English able to understand and provide informed consent
  • End stage renal disease listed for primary solitary kidney transplant
  • Willing to participate in the study and comply with study requirements
  • Female participants must agree to use 2 different birth control methods

Exclusion Criteria:

  • History of previous organ, tissue or cell transplant
  • Known sensitivity to Sirolimus, Everolimus, Tacrolimus or MMF
  • Previous chronic use of systemic glucocorticoids or other immunosuppression, or biologic immunomodulators
  • Significant or active infection: HIV, Hepatitis B and C
  • Active cancer or history of cancer within 3 years of screening
  • Participation in other study that involved investigational drug or regimens in the preceding 12 months
  • History of delayed or abnormal wound healing
  • Delayed graft function
  • Chronic illness or prior treatment which, in the opinion of the investigator, precludes study participation
  • Pregnant or breastfeeding or refusal to us birth control
  • Inability or unwillingness to comply with study protocol or procedures
  • Chronic use of anticoagulants
  • Blood transfusion 3 months prior to transplant
  • History of non-compliance

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 identifier (NCT number): NCT03284242

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United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Roberto Gedaly, MD    859-323-1691   
Sponsors and Collaborators
Roberto Gedaly
Novartis Pharmaceuticals
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Principal Investigator: Roberto Gedaly, MD University of Kentucky

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Roberto Gedaly, Sponsor/Investigator, University of Kentucky Identifier: NCT03284242     History of Changes
Other Study ID Numbers: 16-0779-F6A
CRAD001AUS210T ( Other Grant/Funding Number: Novartis )
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Roberto Gedaly, University of Kentucky:
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs