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Completed

NCT Number: NCT03083756

Validation of a Risk Score Opportunistic Infections Development in Kidney Transplant Patients

This study validate the usefulness of SIMPLICITY score to characterize the immune status of the kidney transplant receiver at two points along its course (the one and six months after transplantation), by determination in peripheral blood of various parameters related to cellular immunity (count subpopulations of CD3+ (cluster of differentiation 3), CD4+ (cluster of differentiation 4) and CD8+( cluster of differentiation 8)), humoral immunity (immunoglobulins count) and innate (complement).

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Key information

Conditions

Opportunistic Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

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About this study

The monitoring of various parameters related to cellular and humoral immunity (lymphocytes, immunoglobulins and complement) through a score (SIMPLICITY) (8) would allow the identification of renal transplant recipients at high risk for post-transplant infection. Prolonged or prolonged use of CMV (Cytomegalovirus) prophylaxis may modify this risk.

The SIMPLICITY score (Seeking for Immune Status based on Peripheral Blood Lymphocytes, Immunoglobulins and Complement Activity) is a practical score based on the monitoring of readily available immunological parameters to assess the risk of infection after RT (Renal transplant). In order to perform this score, the total lymphocyte counts and peripheral blood lymphocyte subpopulations (PBLSs), serum immunoglobulin levels (IgG, IgA (Immunoglobulin A) and IgM) and serum complement levels (C3 and C4) at baseline were investigated, at one month and 6 months after transplantation.

The validation of this new score would allow to have a weapon that would lead to reduce to the maximum the pharmacological immunosuppression and to use strict prophylactic measures in these patients.

The results of the present study may provide insight into clinically and scientifically relevant aspects of infection in the recipient of an RT undergoing immunosuppressive therapy:

From the point of view of assistance, if the hypothesis of the study were confirmed, the possibility of elaborating specific strategies of prophylaxis and early treatment (antibiotic, antifungal or antiviral), adjusted to the risk of the recipient to present some infectious event during its evolution post transplantation according to the SIMPLICITY score.

Likewise, it could lay the foundations for the design of individualized immunosuppression guidelines, in which the risk of infectious complications could be evaluated jointly with that of graft rejection. And all this based on simple immunological parameters, of economic determination and accessible for most of the centers of our environment, circumstance that would favor its immediate application in the usual clinical practice.

Given that the literature on this line of research is scarce, and the hypothesis we intend to demonstrate is novel and conceptually attractive, the results of this study will be able to be published in journals with a high impact index in the field of immunology and Management of infectious complications in the RT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Renal transplant patients whose variables can be properly monitored throughout the first year post-transplant.
  • Older than 18 years.
  • Patients who have signed the informed consent form.

Exclusion criteria

  • Infection with the human immunodeficiency virus (HIV).
  • Patient who dies during the first month after transplant.
  • Pre-transplant diagnosis of primary immunodeficiency (eg. Common variable immunodeficiency, idiopathic CD4 lymphopenia, etc)
  • Patient is participating in another clinical trial with a molecule under investigation.

Treatment and study plan

Primary outcomes

  1. To validate SIMPLICITY Score to characterize the immunological situation of the RT recipient at month of transplantation).

    Time frame: At 1 month from transplant

    To validate the SIMPLICITY will be scored from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD8+ (<0.200x103/MicroL at month 1)

  2. To validate SIMPLICITY Score to characterize the immunological situation of the RT recipient at six months of transplantation.

    Time frame: At 6 months from transplant

    To validate the SIMPLICITY will be scored from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD3+ (<0.500x103 MicroL at 6 months).

Secondary outcomes

  1. Correlation of IgG and infectious complications

    Time frame: Up to 12 moths from transplant

    Correlation of IgG and the incidence of infectious complications increased.

  2. Correlation of C3 and infectious complications

    Time frame: Up to 12 moths from transplant

    Correlation of C3 and the incidence of infectious complications increased.

  3. Correlation of count lymphocyte T CD3+ in Peripheral blood and infectious complications

    Time frame: Up to 12 moths from transplant

    Correlation count of lymphocyte subpopulations CD3+ and the incidence of infectious complications increased.

  4. Correlation of count lymphocyte T CD8+ in Peripheral blood and infectious complications

    Time frame: Up to 12 moths from transplant

    Correlation count of lymphocyte subpopulations CD8+ and the incidence of infectious complications increased.

  5. Acute rejection with histologic confirmation by conventional criteria

    Time frame: Up to 12 moths from transplant

    Number of patients who have had at least one acute biopsy-proven rejection throughout the study.

  6. Graft loss with or without retransplantation.

    Time frame: Up to 12 moths from transplant

    Number of patients who have lost the graft throughout the study.

  7. Mortality infectious cause

    Time frame: Up to 12 moths from transplant

    Number of dead patients and whose cause of death is Infection.

  8. Mortality otherwise.

    Time frame: Up to 12 moths from transplant

    Number of dead patients whose cause of death has indicated a different cause to Infection (ie the reason for death was due to ischemic heart disease, or by another cardiovascular complication, or by neoplastic disease or by others).

  9. CMV infection/Disease

    Time frame: Up to 12 moths from transplant

    Percentage of patients presenting at least one CMV disease throughout the study, from the transplant and number of CMV diseases per patient.

  10. CMV viremia

    Time frame: Up to 12 moths from transplant

    Number of patients who had CMV positive viremia (either PCR (Polymerase Chain Reaction) or antigenemia) at least during one visit (No. of copies>0 IU/mL in PCR or>100,000/cell in Antigenemia).

  11. To analyze the influence of low lymphocyte count in the increase of the rate of major infectious complications.

    Time frame: Up to 12 moths from transplant

    Low lymphocyte count, defined as lymphocytes <1500 cells/mcl and the rate of major infectious complications

  12. To analyze the influence of CMV serology in the increase of the rate of major infectious complications.

    Time frame: Up to 12 moths from transplant

    CMV receptor serology vs. donor CMV Serology (ie, a new categorical variable will be constructed combining donor and recipient serology: D+/R+, D-/R +,D-/R-, D+/R-) and the rate of major infectious complications

  13. To analyze the influence of Historical PRA (Panel Reactive Antibody) in the increase of the rate of major infectious complications

    Time frame: Up to 12 moths from transplant

    Historical PRA (%) and the rate of major infectious complications

  14. To analyze whether viremia has any impact on the occurrence of other opportunistic diseases

    Time frame: Up to 12 moths from transplant

    Presence of major post-transplant infectious complication and the occurrence of other opportunistic diseases.

  15. To analyze whether CMV disease has any impact on the occurrence of other opportunistic diseases.

    Time frame: Up to 12 moths from transplant

    Presence of CMV disease and the occurrence of other opportunistic diseases.

  16. To analyze the role of Anticipated treatment and the influence in the appearance of infection or disease by CMV.

    Time frame: Up to 12 moths from transplant

    Indication of Anticipated treatment and appearance of infection or disease by CMV.

  17. To analyze the role of Antiviral prophylaxis and the influence in the appearance of infection or disease by CMV.

    Time frame: Up to 12 moths from transplant

    Indication of Antiviral prophylaxis appearance of infection or disease by CMV.

  18. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on overall survival throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 1 month of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD8+ (<0.200x103/MicroL at month 1)) and overall survival throughout the first year of evolution.

  19. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on graft survival throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 1 month of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD8+ (<0.200x103/MicroL at month 1)) and graft survival throughout the first year of evolution.

  20. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on the incidence of acute rejection throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 1 month of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD8+ (<0.200x103/MicroL at month 1)) and the incidence of acute rejection throughout the first year of evolution.

  21. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on vascular disease throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 1 month of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD8+ (<0.200x103/MicroL at month 1)) and vascular disease throughout the first year of evolution.

  22. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on diabetes throughout the first year of evolution throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 1 month of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD8+ (<0.200x103/MicroL at month 1)) and diabetes throughout the first year of evolution throughout the first.

  23. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on overall survival throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 6 months of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD3+ (<0.500x103 MicroL at 6 months)) and overall survival throughout the first year of evolution.

  24. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on graft survival throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 6 months of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD3+ (<0.500x103 MicroL at 6 months)) and graft survival throughout the first year of evolution.

  25. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on the incidence of acute rejection throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 6 months of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD3+ (<0.500x103 MicroL at 6 months)) and the incidence of acute rejection throughout the first year of evolution.

  26. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on vascular disease throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 6 months of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD3+ (<0.500x103 MicroL at 6 months)) and vascular disease throughout the first year of evolution.

  27. To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on diabetes throughout the first year of evolution throughout the first year of evolution.

    Time frame: Up to 12 moths from transplant

    SIMPLICITY Score at 6 months of transplantation (from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (<700 mg/ dL) , C3 hypocomplementemia (<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD3+ (<0.500x103 MicroL at 6 months)) and diabetes throughout the first year of evolution throughout the first.

Sponsors and collaborators

Lead sponsor

Sociedad Española de Trasplante

Other

Collaborators

  • Roche Farma, S.A

Registry information

Official study title

Prospective Observational Study for the Validation of a Risk Score Opportunistic Infections Development in Kidney Transplant Patients

Acronym: SIMPLICITY

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2017
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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