Development of a National Incompatible Kidney Transplant Registry

Summary

Principal Investigator: Robert A Montgomery
Abstract: DESCRIPTION (provided by applicant): Summary This application addresses broad Challenge Area (07) Enhancing Clinical Trials and specific Challenge Topic, 07-DK-103: Support for Registries. Live donor kidney transplantation is the best treatment for kidney failure, doubling life expectancy and significantly improving quality of life. However, it is estimated that 2000-4000 patients every year find a healthy, willing live donor but are relegated to forego the benefits of live donor renal transplantation because they are ABO or HLA incompatible with their donor. Some of these patients might find compatible matches through kidney paired donation, but those with broad HLA sensitization or hard-to-match blood types (over 50% of incompatible pairs) will not find matches through paired donation. Without incompatible kidney transplantation (IKT), the only other option for these patients is to join the 80,000-patient deceased donor waiting list, where waiting times average 5-7 years and death rates on dialysis exceed 10% per year. IKT is an emerging practice in which patients can receive kidney transplants across antibody barriers through the use of various desensitization techniques. Approximately 200 of these transplants are performed annually in the United States, of which approximately one-third are performed by a handful of high-volume centers and two-thirds are scattered across approximately 90 other very low-volume centers. However, two major challenges currently limit future growth in the field of IKT. First, there is a great need to study and validate specific components of the current protocols and develop best practice. This can only be accomplished if sufficient, detailed data from multiple centers can be collected in a prospective fashion;to date, only single-center studies have been available for analysis. Second, because IKT can be hard to implement due to its reliance on new technology in immunogenetics and pathology, there is a great need for mentoring of new provider teams by more experienced centers. This is currently limited by the inability to readily share detailed, integrated, longitudinal clinical, histological, radiographic, and immuogenetics data. In an effort to better understand IKT and mentor new centers building these programs, we propose to develop a National Incompatible Kidney Transplant Registry. We will design this registry based on a systematic set of in-depth interviews with personnel currently involved in this procedure, and then extend currently existing relational patient management software to accommodate the needs of this registry. We will then pilot test the registry on retrospective cases at our center, prospective cases at our center, and prospective cases from a handful of centers around the country. Finally, we will develop a long-term plan for sustainability. For sensitized patients, IKT is often the only viable treatment option, providing a significant (more than 3- fold) survival benefit to these patients when compared to the next-best available option, namely waiting on the deceased donor waiting list for a compatible donor. Expanding this treatment modality will not only save lives, decrease the long waiting list, and save the US healthcare system significant costs, but will also stimulate the expansion of transplant centers, tissue typing labs, and pathology labs nationwide. Although live donor kidney transplantation is the best treatment for kidney failure, thousands of patients each year have a healthy, willing donor but are relegated to forego the benefits of live donor transplantation because they are incompatible with their donor. Incompatible kidney transplantation is an emerging practice in which patients can receive kidney transplants from their incompatible donors, but this field has thus far been limited to single-center experiences where protocols cannot be validated, best practice cannot be developed, and mentorship of new centers by more experienced centers cannot be accomplished. The goal of this project is to create a detailed, integrated, National Incompatible Kidney Transplant Registry that will link clinical, biopsy, radiology, and antibody data from multiple centers throughout the United States in a way that will greatly improve and expand incompatible kidney transplantation.
Funding Period: ----------------2009 - ---------------2011-
more information: NIH RePORT

Top Publications

  1. ncbi Histologic phenotype on 1-year posttransplantation biopsy and allograft survival in HLA-incompatible kidney transplants
    Adnan Sharif
    1 Renal Institute of Birmingham, Queen Elizabeth Hospital, Birmingham, United Kingdom 2 Department of Medicine, Johns Hopkins Medical Institutions, Baltimore, MD 3 Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, MD 4 Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD 5 Address correspondence to Robert Montgomery, Ph D, Department of Surgery, Johns Hopkins Medical Institutions, 720 Rutland Avenue, Ross Research 765, Baltimore, MD 21205
    Transplantation 97:541-7. 2014
  2. ncbi Transplanting the highly sensitized patient: trials and tribulations
    Hariharan S Iyer
    aDivision of Nephrology and Transplantation, Department of Medicine, London Health Sciences Center, The University of Western Ontario, London, Ontario, Canada bDepartment of Medicine cDepartment of Surgery, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
    Curr Opin Nephrol Hypertens 22:681-8. 2013
  3. pmc Center-level utilization of kidney paired donation
    A B Massie
    Department of Surgery Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA
    Am J Transplant 13:1317-22. 2013
  4. ncbi HLA incompatible renal transplantation
    Robert A Montgomery
    Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
    Curr Opin Organ Transplant 17:386-92. 2012
  5. ncbi Infusion of high-dose intravenous immunoglobulin fails to lower the strength of human leukocyte antigen antibodies in highly sensitized patients
    Nada Alachkar
    Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
    Transplantation 94:165-71. 2012
  6. pmc Incidence and outcomes of BK virus allograft nephropathy among ABO- and HLA-incompatible kidney transplant recipients
    Adnan Sharif
    Renal Institute of Birmingham, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom
    Clin J Am Soc Nephrol 7:1320-7. 2012
  7. pmc Outcomes of ABO-incompatible kidney transplantation in the United States
    John R Montgomery
    Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA
    Transplantation 93:603-9. 2012
  8. ncbi Desensitization in HLA-incompatible kidney recipients and survival
    Robert A Montgomery
    Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, MD, USA
    N Engl J Med 365:318-26. 2011
  9. pmc Incompatible live-donor kidney transplantation in the United States: results of a national survey
    Jacqueline M Garonzik Wang
    Transplant Surgery, Johns Hopkins Medical Institutions, 720 Rutland Avenue, Ross 771B, Baltimore, MD 21205, USA
    Clin J Am Soc Nephrol 6:2041-6. 2011
  10. ncbi Using donor exchange paradigms with desensitization to enhance transplant rates among highly sensitized patients
    Robert A Montgomery
    Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
    Curr Opin Organ Transplant 16:439-43. 2011

Scientific Experts

  • Robert A Montgomery
  • Dorry L Segev
  • Adnan Sharif
  • Nada Alachkar
  • Andrea A Zachary
  • A B Massie
  • Hariharan S Iyer
  • Bonnie E Lonze
  • John R Montgomery
  • Daniel S Warren
  • Jonathan C Berger
  • Sommer E Gentry
  • Jacqueline M Garonzik Wang
  • Edward S Kraus
  • Serena M Bagnasco
  • Susanna M Nazarian
  • Lois J Arend
  • Lorraine C Racusen
  • S E Gentry
  • A A Bingaman
  • Annette M Jackson
  • D L Segev
  • Karl Womer
  • Lorraine Racusen
  • Gaurav Gupta
  • Mary J Holechek
  • Lois Arend
  • Nathan T James
  • Duvuru Geetha
  • Andrew L Singer
  • Niraj M Desai
  • Karl Schillinger
  • Nabil N Dagher
  • Serena Bagnasco
  • Andrew M Cameron
  • Edward Kraus
  • Lauren M Kucirka

Detail Information

Publications12

  1. ncbi Histologic phenotype on 1-year posttransplantation biopsy and allograft survival in HLA-incompatible kidney transplants
    Adnan Sharif
    1 Renal Institute of Birmingham, Queen Elizabeth Hospital, Birmingham, United Kingdom 2 Department of Medicine, Johns Hopkins Medical Institutions, Baltimore, MD 3 Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, MD 4 Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD 5 Address correspondence to Robert Montgomery, Ph D, Department of Surgery, Johns Hopkins Medical Institutions, 720 Rutland Avenue, Ross Research 765, Baltimore, MD 21205
    Transplantation 97:541-7. 2014
    ..The correlation between histopathologic phenotypes and allograft outcomes among patients desensitized for donor-specific antibody (HLA-incompatible) is unknown...
  2. ncbi Transplanting the highly sensitized patient: trials and tribulations
    Hariharan S Iyer
    aDivision of Nephrology and Transplantation, Department of Medicine, London Health Sciences Center, The University of Western Ontario, London, Ontario, Canada bDepartment of Medicine cDepartment of Surgery, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
    Curr Opin Nephrol Hypertens 22:681-8. 2013
    ..The number of highly sensitized patients on the renal transplant waiting list continues to increase. This review focuses on the options available to these patients and speculates on future directions for incompatible transplantation...
  3. pmc Center-level utilization of kidney paired donation
    A B Massie
    Department of Surgery Department of Epidemiology, Johns Hopkins School of Public Health, Baltimore, MD, USA
    Am J Transplant 13:1317-22. 2013
    ..2 (from 494 to 1593). Broader implementation of KPD across a wide number of centers is crucial to properly serve transplant candidates with healthy but incompatible live donors...
  4. ncbi HLA incompatible renal transplantation
    Robert A Montgomery
    Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
    Curr Opin Organ Transplant 17:386-92. 2012
    ..This review describes the transplantation modalities available to the sensitized patient and discusses aspects of the donor/recipient phenotypes that determine the most suitable option for a particular patient...
  5. ncbi Infusion of high-dose intravenous immunoglobulin fails to lower the strength of human leukocyte antigen antibodies in highly sensitized patients
    Nada Alachkar
    Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
    Transplantation 94:165-71. 2012
    ..HLA antibody reduction and favorable transplantation rates have been reported after treatment with high-dose intravenous immunoglobulin (IVIg)...
  6. pmc Incidence and outcomes of BK virus allograft nephropathy among ABO- and HLA-incompatible kidney transplant recipients
    Adnan Sharif
    Renal Institute of Birmingham, Queen Elizabeth Hospital, Edgbaston, Birmingham, United Kingdom
    Clin J Am Soc Nephrol 7:1320-7. 2012
    ..BKVAN link to rejection and graft accommodation phenotype were also explored. The Johns Hopkins Institutional Review Board approved this study...
  7. pmc Outcomes of ABO-incompatible kidney transplantation in the United States
    John R Montgomery
    Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA
    Transplantation 93:603-9. 2012
    ..To date, reports of the outcomes from this practice in the United States have been limited to single-center studies...
  8. ncbi Desensitization in HLA-incompatible kidney recipients and survival
    Robert A Montgomery
    Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, MD, USA
    N Engl J Med 365:318-26. 2011
    ..Whether such antibody depletion results in a survival benefit as compared with waiting for an HLA-compatible kidney is unknown...
  9. pmc Incompatible live-donor kidney transplantation in the United States: results of a national survey
    Jacqueline M Garonzik Wang
    Transplant Surgery, Johns Hopkins Medical Institutions, 720 Rutland Avenue, Ross 771B, Baltimore, MD 21205, USA
    Clin J Am Soc Nephrol 6:2041-6. 2011
    ..The goal of this study was to better understand practice patterns of IKT in the United States...
  10. ncbi Using donor exchange paradigms with desensitization to enhance transplant rates among highly sensitized patients
    Robert A Montgomery
    Department of Surgery, Johns Hopkins Medical Institutions, Baltimore, Maryland, USA
    Curr Opin Organ Transplant 16:439-43. 2011
    ..The options for these patients include: remaining on the deceased-donor list, entering a kidney-paired donation scheme, or undergoing desensitization with high-dose IVIg or plasmapheresis and low-dose IVIg...
  11. ncbi Kidney paired donation: fundamentals, limitations, and expansions
    Sommer E Gentry
    Department of Mathematics, US Naval Academy, Annapolis, MD, USA
    Am J Kidney Dis 57:144-51. 2011
    ....