Opportunistic InfectionsSIMPLICITYNCT03083756
Validation of a Risk Score Opportunistic Infections Development in Kidney Transplant Patients
An observational study of Opportunistic Infections, run by Sociedad Española de Trasplante at 15 sites in Spain.
Trial 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+… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opportunistic Infections
- How many people
- 577 participants
- Where
- 15 sitesSpain
- Study dates
- Aug 2014to 15 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal transplant patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña, 15006
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital Vall d´Hebrón
Barcelona, Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital Dr. Negrín
Las Palmas de Gran Canaria, La Palmas, 35010
Hospital Ramón y Cajal
Madrid, Madrid, 28034
Hospital Universitario 12 Octubre
Madrid, Madrid, 28041
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital Carlos Haya
Málaga, Málaga, 29010
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Virgen de la Salud
Toledo, Toledo, 45071
Hospital Universitario Doctor Peset
Valencia, Valencia, 46017
Hospital Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
Official title: Prospective Observational Study for the 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).
Read the 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
- Medical subject headings
- Opportunistic Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: At 6 months from transplant
Secondary outcomes (27)
Correlation of IgG and infectious complications
Correlation of IgG and the incidence of infectious complications increased.
Measured: Up to 12 moths from transplant
Correlation of C3 and infectious complications
Correlation of C3 and the incidence of infectious complications increased.
Measured: Up to 12 moths from transplant
Correlation of count lymphocyte T CD3+ in Peripheral blood and infectious complications
Correlation count of lymphocyte subpopulations CD3+ and the incidence of infectious complications increased.
Measured: Up to 12 moths from transplant
Correlation of count lymphocyte T CD8+ in Peripheral blood and infectious complications
Correlation count of lymphocyte subpopulations CD8+ and the incidence of infectious complications increased.
Measured: Up to 12 moths from transplant
Acute rejection with histologic confirmation by conventional criteria
Number of patients who have had at least one acute biopsy-proven rejection throughout the study.
Measured: Up to 12 moths from transplant
Graft loss with or without retransplantation.
Number of patients who have lost the graft throughout the study.
Measured: Up to 12 moths from transplant
Mortality infectious cause
Number of dead patients and whose cause of death is Infection.
Measured: Up to 12 moths from transplant
Mortality otherwise.
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).
Measured: Up to 12 moths from transplant
CMV infection/Disease
Percentage of patients presenting at least one CMV disease throughout the study, from the transplant and number of CMV diseases per patient.
Measured: Up to 12 moths from transplant
CMV viremia
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).
Measured: Up to 12 moths from transplant
To analyze the influence of low lymphocyte count in the increase of the rate of major infectious complications.
Low lymphocyte count, defined as lymphocytes <1500 cells/mcl and the rate of major infectious complications
Measured: Up to 12 moths from transplant
To analyze the influence of CMV serology in the increase of the rate of major infectious complications.
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
Measured: Up to 12 moths from transplant
To analyze the influence of Historical PRA (Panel Reactive Antibody) in the increase of the rate of major infectious complications
Historical PRA (%) and the rate of major infectious complications
Measured: Up to 12 moths from transplant
To analyze whether viremia has any impact on the occurrence of other opportunistic diseases
Presence of major post-transplant infectious complication and the occurrence of other opportunistic diseases.
Measured: Up to 12 moths from transplant
To analyze whether CMV disease has any impact on the occurrence of other opportunistic diseases.
Presence of CMV disease and the occurrence of other opportunistic diseases.
Measured: Up to 12 moths from transplant
To analyze the role of Anticipated treatment and the influence in the appearance of infection or disease by CMV.
Indication of Anticipated treatment and appearance of infection or disease by CMV.
Measured: Up to 12 moths from transplant
To analyze the role of Antiviral prophylaxis and the influence in the appearance of infection or disease by CMV.
Indication of Antiviral prophylaxis appearance of infection or disease by CMV.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
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.
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.
Measured: Up to 12 moths from transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study startAug 2014
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opportunistic InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Trasplante
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Farma, S.A
- Responsible party
- Sponsor
- Investigators
- José María Aguado, MD, Study chair, Hospital Universitario 12 de OctubreDaniel Serón, MD, Study chair, Hospital Universitario Vall d´HebrónÁngel Alonso, MD, Study chair, Hospital Universitario de A CoruñaDomingo Hernández Marrero, MD, Principal investigator, Hospital Carlos HayaÁlex Gutiérrez Dalmau, MD, Principal investigator, Hospital Miguel ServetRoberto Gallego, MD, Principal investigator, Hospital Dr. NegrínJuan Carlos Ruiz, MD, Principal investigator, Hospital Marqués de ValdecillaFrederic Cofàn, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083756
- Sponsor's protocol ID
- SET-INF-2014-01
- Acronym
- SIMPLICITY
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for the Validation of a Risk Score Opportunistic Infections Development in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT03083756
- Acronym / sponsor ID
- SIMPLICITY / SET-INF-2014-01
- Conditions
- Opportunistic Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- Sociedad Española de TrasplanteUniversity, hospital or other
- Collaborators
- Roche Farma, S.A
- Study start
- Aug 2014
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal transplant patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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).
27 secondary outcomes
Correlation of IgG and infectious complications
Time frame: Up to 12 moths from transplant
Correlation of C3 and infectious complications
Time frame: Up to 12 moths from transplant
Correlation of count lymphocyte T CD3+ in Peripheral blood and infectious complications
Time frame: Up to 12 moths from transplant
Correlation of count lymphocyte T CD8+ in Peripheral blood and infectious complications
Time frame: Up to 12 moths from transplant
Acute rejection with histologic confirmation by conventional criteria
Time frame: Up to 12 moths from transplant
Graft loss with or without retransplantation.
Time frame: Up to 12 moths from transplant
Mortality infectious cause
Time frame: Up to 12 moths from transplant
Mortality otherwise.
Time frame: Up to 12 moths from transplant
CMV infection/Disease
Time frame: Up to 12 moths from transplant
CMV viremia
Time frame: Up to 12 moths from transplant
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
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
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
To analyze whether viremia has any impact on the occurrence of other opportunistic diseases
Time frame: Up to 12 moths from transplant
To analyze whether CMV disease has any impact on the occurrence of other opportunistic diseases.
Time frame: Up to 12 moths from transplant
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José María Aguado, MD study chair
Hospital Universitario 12 de Octubre
Daniel Serón, MD study chair
Hospital Universitario Vall d´Hebrón
Ángel Alonso, MD study chair
Hospital Universitario de A Coruña
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opportunistic Infections, run by Sociedad Española de Trasplante at 15 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate SIMPLICITY Score to characterize the immunological situation of the RT recipient at month of transplantation). (time frame: At 1 month from transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.