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

NCT ID: NCT03083756

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 577 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-02-15

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.

Conditions

Opportunistic Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Farma, S.A

INDUSTRY

Sponsor Role: collaborator

Sociedad Española de Trasplante

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José María Aguado, MD

Role: STUDY_CHAIR

Hospital Universitario 12 de Octubre

Daniel Serón, MD

Role: STUDY_CHAIR

Hospital Universitario Vall d´Hebrón

Ángel Alonso, MD

Role: STUDY_CHAIR

Hospital Universitario de A Coruña

Domingo Hernández Marrero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Carlos Haya

Álex Gutiérrez Dalmau, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Miguel Servet

Roberto Gallego, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr. Negrín

Juan Carlos Ruiz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Marqués de Valdecilla

Frederic Cofàn, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

José M Cruzado, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Daniel Serón, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Vall d´Hebrón

María José Pérez Sáez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar

Miguel Angel Muñoz Cepeda, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Salud

Ángel Alonso, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de A Coruña

Gonzalo Gómez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Espases

Amado Andrés, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

José Mª Portolés, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Puerta de Hierro Majadahonda

Roberto Marcén, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramon y Cajal

Luisa Jimeno Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen de la Arrixaca

Luis M Pallardó Mateu, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Dr. Peset

Locations

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Hospital Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital del Mar

Barcelona, Barcelona, Spain

Hospital Vall d´Hebrón

Barcelona, Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Hospital Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Dr. Negrín

Las Palmas de Gran Canaria, La Palmas, Spain

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Hospital Universitario 12 Octubre

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Carlos Haya

Málaga, Málaga, Spain

Hospital Virgen de la Salud

Toledo, Toledo, Spain

Hospital Universitario Doctor Peset

Valencia, Valencia, Spain

Hospital Miguel Servet

Zaragoza, Zaragoza, Spain

Countries

Spain

Other Identifiers

SET-INF-2014-01

Identifier Type: -

Identifier Source: org_study_id