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

NCT03083756 | Completed

• 1 other identifier: SET-INF-2014-01
• Study Type: observational
• Target: 577
• Locations: 1 country
• Sites: 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).

Conditions

Opportunistic Infections

Outcome Measures

Primary Outcomes (2)

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

  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)

  At 1 month from transplant

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

  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).

  At 6 months from transplant

Secondary Outcomes (27)

• Correlation of IgG and infectious complications

  Up to 12 moths from transplant

• Correlation of C3 and infectious complications

  Up to 12 moths from transplant

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

  Up to 12 moths from transplant

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

  Up to 12 moths from transplant

• Acute rejection with histologic confirmation by conventional criteria

  Up to 12 moths from transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Renal transplant patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedad Española de Trasplante: lead
• Roche Farma, S.A: collaborator

Study Sites (15)

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

Location

Hospital Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Vall d´Hebrón

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Dr. Negrín

Las Palmas de Gran Canaria, La Palmas, 35010, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario 12 Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Carlos Haya

Málaga, Málaga, 29010, Spain

Location

Hospital Virgen de la Salud

Toledo, Toledo, 45071, Spain

Location

Hospital Universitario Doctor Peset

Valencia, Valencia, 46017, Spain

Location

Hospital Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Opportunistic Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• José María Aguado, MD

  Hospital Universitario 12 de Octubre

  STUDY CHAIR

• Daniel Serón, MD

  Hospital Universitario Vall d´Hebrón

  STUDY CHAIR

• Ángel Alonso, MD

  Hospital Universitario de A Coruña

  STUDY CHAIR

• Domingo Hernández Marrero, MD

  Hospital Carlos Haya

  PRINCIPAL INVESTIGATOR

• Álex Gutiérrez Dalmau, MD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Roberto Gallego, MD

  Hospital Dr. Negrín

  PRINCIPAL INVESTIGATOR

• Juan Carlos Ruiz, MD

  Hospital Marqués de Valdecilla

  PRINCIPAL INVESTIGATOR

• Frederic Cofàn, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• José M Cruzado, MD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

• Daniel Serón, MD

  Hospital Universitario Vall d´Hebrón

  PRINCIPAL INVESTIGATOR

• María José Pérez Sáez, MD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

• Miguel Angel Muñoz Cepeda, MD

  Hospital Virgen de la Salud

  PRINCIPAL INVESTIGATOR

• Ángel Alonso, MD

  Hospital Universitario de A Coruña

  PRINCIPAL INVESTIGATOR

• Gonzalo Gómez, MD

  Hospital Son Espases

  PRINCIPAL INVESTIGATOR

• Amado Andrés, MD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

• José Mª Portolés, MD

  Hospital Universitario Puerta de Hierro Majadahonda

  PRINCIPAL INVESTIGATOR

• Roberto Marcén, MD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

• Luisa Jimeno Garcia, MD

  Hospital Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

• Luis M Pallardó Mateu, MD

  Hospital Dr. Peset

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 20, 2017
• Study Start: August 1, 2014
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: March 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (15)