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Non-adherence to Immunosuppressives in Kidney Transplantation in Brazil Multicenter Study (ADHEREBRAZIL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi
Sponsor:
Collaborators:
Hospital das Clínicas de São Paulo – SP
Instituto de Urologia e Nefrologia - São José Rio Preto/SP
Hospital do Rim/UNIFESP – SP
Hospital Israelita Albert Einstein
Hospital de Clinicas da Unicamp – SP
Hospital São Francisco de Assis na Providência de Deus - RJ
Hospital Universitário UFJF - MG
Santa Casa de Juiz de Fora – MG
Fundação Prorim Hospital Municipal de São José Joinvile – SC
Santa Casa de Porto Alegre – RS
Hospital das Clínicas de Porto Alegre - RS
Hospital e Maternidade Angelina Caron - SC
Hospital Universitário do Maranhão – MA
Hospital Walter Cantidio - CE
Hospital Ofir Loyola – PA
Santa Casa de Misericórdia de Belo Horizonte - MG
Hospital São João de Deus - Divinolopis-MG
Hospital Antonio Targino- PB
University of Brasilia
Hospital Onofre Lopes - RN
Information provided by (Responsible Party):
Helady Pinheiro, MD, PhD, Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi
ClinicalTrials.gov Identifier:
NCT02066935
First received: October 10, 2013
Last updated: September 6, 2016
Last verified: May 2016
  Purpose
The purpose of this study is identify the prevalence of non-adherence to immunosuppressives in Brazilian renal transplant recipients, identify the factors related to non-adherence in the studied population and identify the prevalence of non-adherence in the different regions of the country.

Condition Intervention
Medication Adherence
Other: kidney transplant patient

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Non-adherence to Immunosuppressives in Kidney Transplantation in Brazil: Diagnosis and Associations - ADHERE BRAZIL Multicenter Study

Resource links provided by NLM:


Further study details as provided by Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi:

Primary Outcome Measures:
  • adherence to immunosuppressives [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Adherence will be defined by three methods: The BAASIS instrument, blood assay of the immunosuppressives and collateral report. A patients is classified as non-adherent if he/she is considered non-adherent by any of the methods.


Secondary Outcome Measures:
  • Risk factors to non-adherence [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Risk factors to non-adherence are socio-economic; patient-related; condition/disease-related; therapy/treatment-related;healthcare system/healthcare worker-related factors


Estimated Enrollment: 1500
Study Start Date: September 2015
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
kidney transplant patient
Kidney transplanted patients for at least one year
Other: kidney transplant patient
kidney transplanted patients for at least one year

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kidney Transplant patient
Criteria

Inclusion Criteria:

  • Being at least 18 years old
  • More than 1 year posttransplant
  • Willing to participate in the study by signing a written informed consent form.

Exclusion Criteria:

- Retransplant

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066935

Contacts
Contact: HELADY S PINHEIRO, MD, PhD 553299828439 heladysanders@gmail.com
Contact: ELISA O MARSICANO 553299793943 elisadeom@gmail.com

Locations
Brazil
Fundação Instituto Mineiro de Estudos e Pesquisas em Nefrologia Recruiting
Juiz de Fora, Minas Gerais, Brazil, 36036-330
Contact: ELISA O MARSICANO    553299793943    elisadeom@gmail.com   
Contact: MARIA S VAN KEULEN    553232369250    maria.keulen@hotmail.com   
Principal Investigator: HELADY S PINHEIRO, MD, PhD         
Sub-Investigator: ELISA O MARSICANO         
Sponsors and Collaborators
Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi
Hospital das Clínicas de São Paulo – SP
Instituto de Urologia e Nefrologia - São José Rio Preto/SP
Hospital do Rim/UNIFESP – SP
Hospital Israelita Albert Einstein
Hospital de Clinicas da Unicamp – SP
Hospital São Francisco de Assis na Providência de Deus - RJ
Hospital Universitário UFJF - MG
Santa Casa de Juiz de Fora – MG
Fundação Prorim Hospital Municipal de São José Joinvile – SC
Santa Casa de Porto Alegre – RS
Hospital das Clínicas de Porto Alegre - RS
Hospital e Maternidade Angelina Caron - SC
Hospital Universitário do Maranhão – MA
Hospital Walter Cantidio - CE
Hospital Ofir Loyola – PA
Santa Casa de Misericórdia de Belo Horizonte - MG
Hospital São João de Deus - Divinolopis-MG
Hospital Antonio Targino- PB
University of Brasilia
Hospital Onofre Lopes - RN
Investigators
Principal Investigator: HELADY S PINHEIRO, MD, PhD Fundação Instituto Mineiro de Estudos e Pesquisas em Nefrologia
  More Information

Publications:
Sabaté E. Adherence to long-term therapies: Evidence for action. Geneva: World Health Organization. 2003.
Registro Brasileiro de Transplante 2012 [Online]. Available at: http://www.abto.com.br/profissionais.

Responsible Party: Helady Pinheiro, MD, PhD, MD; PhD, Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi
ClinicalTrials.gov Identifier: NCT02066935     History of Changes
Other Study ID Numbers: ADHEREBZ-001 
Study First Received: October 10, 2013
Last Updated: September 6, 2016
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi:
immunosuppression
medication nonadherence
kidney transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016