IMMUNE TOLERANCE INDUCTION

HLA MATCHED LIVING DONOR

KIDNEY AND BONE MARROW TRANSPLANTATION 

 

 

OPEN ENROLLMENT

Mercury Study 

A Phase 3 Prospective, Randomized, Multi-Center, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy with MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants.

Funded by: Medeor Therapeutics, Inc.

How To Enroll Into Study?

If, after reading the Brief Description of this study and the Information package, you are still interested in participating in this study, please proceed to the pre-screening questions below:

 

 

 

STEP 1.

Let's check first, if you qualify for the study:

RECIPIENT:

  • Do you plan on being a recipient of a first kidney allograft from an HLA-matched, living related donor?

       (HLA-matched defined as identical for both alleles at the following genetic loci: HLA-A, HLA-B, and HLA-        DRB1)

  • Are you ≥ 18 and ≤ 65 years old?

  • Will you receive a kidney transplant only? 

DONOR: 

  • Are you a HLA-matched first-degree (parent, child or sibling) or second-degree (child of a sibling or half sibling) relative of the prospective recipient participant? 

  • Are you ≥ 18 and ≤ 65 years old? 

  • If one of the answers is No, you do not qualify and we would like to thank you for your interest and time. 

  • If you answered Yes to all 3 questions, please proceed to the Step 2 below.

STEP 2. Now, let's check if you might have a condition, which does not allow you to participate in the study:

 

RECIPIENT: 

  • Have an Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney, including: FSGS, Type I or II MPGN?

  • Do you have hemolytic-uremic syndrome (HUS) or thrombotic thrombocytopenic purpura (TTP)?

  •  Have a history of clinically important genitourinary tract dysfunction?

  • Have a history of undergoing a prior hematopoietic cell transplant, organ transplant, any cell therapy, or any gene therapy? 

  • Female: Are you pregnant, planning on being pregnant, or breastfeeding?

  • Male: Do you intend to procreate during the duration of the study? 

 

DONOR: 

  • Do you have a known sensitivity to filgrastim or to E. coli-derived recombinant protein products?

  • Do you have a history of autoimmune disorders, including rheumatic diseases and unsuccessfully treated thyroid disorders?

  • Do you have a history of undergoing a prior hematopoietic cell transplant, organ transplant, any cell therapy, or any gene therapy?

  • Do you have a history of type 1 or type 2 diabetes mellitus?

  • Do you have a history of deep vein thrombosis or pulmonary embolism?

  • Do you have a history of iritis or episcleritis?

  • Are you currently being treated with lithium?

  • Are you taking any Immunosuppresive therapy (e.g., glucocorticoids, CsA, Tac, mycophenolate, or TNF inhibitor).

  • Do you have a Positive Hemoglobin-Solubility (e.g., SickleDex™ or equivalent) test?

  • Do you have any tests confirmed positive for HIV-1/2, HTLV-I/II, West Nile Virus, HBV, HCV , T. cruzi, or syphilis?

  • Do you have any history of infection with Zika virus (ZIKV) in the past 6 months?

  • Do you have any history of myeloid leukemia, myeloproliferative disease or prior hematopoietic cell transplant?

If one of the answers is YES, we are sorry but you cannot participate in the study.

 

If you are unsure, you can always contact us with additional questions for clarification:

Lindsay.Basto@uchicago.edu or fax 773-702-2127.

If all answers are NO to all questions above, please proceed to the step 3.

STEP 3.

Please download, fill out the questionnaire:

 

Patient Pre-Screening Questionnaire 

 

and send it by email to Lindsay.Basto@uchicago.edu or fax 773-702-2127.

STEP 4. 

Only for those individuals who received an invitation from us to proceed to this step!

 

Please download the form and take it to your diabetologist to be filled out, signed and emailed to Lindsay.Basto@uchicago.edu, or fax to 773-702-2127.

 

Physician Pre-Screening Questionnaire 

 

 

Additional Information for patients interested in the Study provided by the Sponsor you can find HERE.  

CONTACT:

 

 

 

 

 

 

 

 

Transplantation Institute

Clinical  Research Center

 

Islet and Kidney Transplantation

Manager, Lindsay Basto RN MSN 

Lindsay.Basto@uchospitals.edu

tel. (773) 702-2504

fax (773) 926-0671

 

Islet and Cell Processing and Research

Manager, Karolina Golab, PhD

kgolab@surgery.bsd.uchicago.edu


Transplantation Institute

University of Chicago Medicine

5841 S. Maryland Avenue

MC 5026, J-517

Chicago IL 60637

Polish-American Transplant Center

Clinical Coordinator

Patrycja Ulijaszyk RN 

Patrycja.Ulijaszyk@uchospitals.edu

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© 2018 by Kajetan Witkowski