Kidney Transplantation Current Trials

Project Title:
Noninvasive Diagnosis of Renal Allograft Rejection by Urinary Cell mRNA Profiling (CTOT-04)

Purpose:
The purpose of this study is to find a way to see if rejection is about to occur. We are looking at mRNA levels in urine samples to see if they predict the development of acute rejection. Taking part in this study requires blood and/or urine samples over a 36-month period.

Inclusion criteria:

  • Male and female recipients of all races, 0 - 80 years of age
  • Patients undergoing primary or re-do living or deceased donor kidney transplantation
  • Ability to provide informed consent

Sponsor:
NIAID/NIH

Principle Investigator:
Michael Abecassis, MD

Cost:
None

Contact:
Jane Charette, RN (312) 503-0256


Project Title: Immunophenotyping and Functional Profiles of Peripheral Lymphocytes in Renal Transplant Recipients after T Cell Depletion with Alemtuzumab (anti-CD52 monoclonal antibody). Potential Implications for Safe Immunosuppression minimization


Purpose:
The purpose of this study is to discover how the immunosuppressive medication, alemtuzumab (Campath-1H), affects the B and T cells of your immune system. By looking at these cells using a number of laboratory tests, we may be able to determine how many of these cells are actively working. This study will enroll 50 newly transplanted subjects and take place over a 12 - 18 month period.

Inclusion trial criteria:

  • Adult subjects between ages 18-65 of either gender
  • Recipients have an available ABO compatible living donor for transplant
  • Subjects are listed to be a single-organ recipient (kidney only)
  • Subjects have the ability to provide informed consent


Sponsor:
American Society of Transplantation Grant

Principle Investigator:
Lorenzo Gallon, MD

Cost:
None

IRB Project Number:
0773-011

Contact:
Linda B. Roberts, RN (312) 503-0252


Project Title: A Phase IV, Single Center Pilot Study Using Alemtuzumab (Campath-1H) Induction Combined with Prednisone-Free and Calcineurin-Inhibitor-Free Immunosuppression in Kidney Transplantation. "Cell 220"

Purpose:
The purpose of this study is to evaluate the efficacy and safety of a combined prednisone-free and calcineurin-inhibitor-free immunosuppression protocol in kidney transplantation. Also, the investigator seeks to assess the incidence and characteristics of biopsy-proven acute allograft rejection in the first six months post transplant. This study seeks to enroll 45 subjects who will be followed over a 12-month period. Inclusion trial criteria: Subjects with end-stage renal disease (ESRD) who undergo a living donor kidney transplant.

Inclusion trial criteria:
Subjects with end-stage renal disease (ESRD) who undergo a living donor kidney transplant.

Sponsor:
Roche

Principle Investigator:
Joseph Leventhal, MD, PhD

Cost:
None

Contact: Karen Matijevich (312) 503-5213

IRB Project Number:
0811-007