Clinical trial NCT03083756: Validation of a Risk Score Opportunistic Infections Development in Kidney Transplant Patients
Official title: Prospective Observational Study for the Validation of a Risk Score Opportunistic Infections Development in Kidney Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opportunistic Infections
Lead sponsor: Sociedad Española de Trasplante
Sponsor class: OTHER
Collaborators: name: Roche Farma, S.A
First posted: 2017-03-20
Enrollment: 577
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant patients

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To validate SIMPLICITY Score to characterize the immunological situation of the RT recipient at month of transplantation).
timeFrame: At 1 month from transplant
measure: To validate SIMPLICITY Score to characterize the immunological situation of the RT recipient at six months of transplantation.
timeFrame: At 6 months from transplant
Secondary outcomes:
measure: Correlation of IgG and infectious complications
timeFrame: Up to 12 moths from transplant
measure: Correlation of C3 and infectious complications
timeFrame: Up to 12 moths from transplant
measure: Correlation of count lymphocyte T CD3+ in Peripheral blood and infectious complications
timeFrame: Up to 12 moths from transplant
measure: Correlation of count lymphocyte T CD8+ in Peripheral blood and infectious complications
timeFrame: Up to 12 moths from transplant
measure: Acute rejection with histologic confirmation by conventional criteria
timeFrame: Up to 12 moths from transplant
measure: Graft loss with or without retransplantation.
timeFrame: Up to 12 moths from transplant
measure: Mortality infectious cause
timeFrame: Up to 12 moths from transplant
measure: Mortality otherwise.
timeFrame: Up to 12 moths from transplant
measure: CMV infection/Disease
timeFrame: Up to 12 moths from transplant
measure: CMV viremia
timeFrame: Up to 12 moths from transplant
measure: To analyze the influence of low lymphocyte count in the increase of the rate of major infectious complications.
timeFrame: Up to 12 moths from transplant
measure: To analyze the influence of CMV serology in the increase of the rate of major infectious complications.
timeFrame: Up to 12 moths from transplant
measure: To analyze the influence of Historical PRA (Panel Reactive Antibody) in the increase of the rate of major infectious complications
timeFrame: Up to 12 moths from transplant
measure: To analyze whether viremia has any impact on the occurrence of other opportunistic diseases
timeFrame: Up to 12 moths from transplant
measure: To analyze whether CMV disease has any impact on the occurrence of other opportunistic diseases.
timeFrame: Up to 12 moths from transplant
measure: To analyze the role of Anticipated treatment and the influence in the appearance of infection or disease by CMV.
timeFrame: Up to 12 moths from transplant
measure: To analyze the role of Antiviral prophylaxis and the influence in the appearance of infection or disease by CMV.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
measure: 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.
timeFrame: Up to 12 moths from transplant
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
state: Cantabria
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
state: Islas Baleares
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Dr. Negrín
state: La Palmas
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 Octubre
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Universitario 12 de Octubre
name: José María Aguado, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario Vall d´Hebrón
name: Daniel Serón, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario de A Coruña
name: Ángel Alonso, MD
role: STUDY_CHAIR
affiliation: Hospital Carlos Haya
name: Domingo Hernández Marrero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Miguel Servet
name: Álex Gutiérrez Dalmau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Dr. Negrín
name: Roberto Gallego, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Marqués de Valdecilla
name: Juan Carlos Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Frederic Cofàn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari de Bellvitge
name: José M Cruzado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Vall d´Hebrón
name: Daniel Serón, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: María José Pérez Sáez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Salud
name: Miguel Angel Muñoz Cepeda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de A Coruña
name: Ángel Alonso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Espases
name: Gonzalo Gómez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre
name: Amado Andrés, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Puerta de Hierro Majadahonda
name: José Mª Portolés, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramon y Cajal
name: Roberto Marcén, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Arrixaca
name: Luisa Jimeno Garcia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Dr. Peset
name: Luis M Pallardó Mateu, MD
role: PRINCIPAL_INVESTIGATOR
References: