Prevalence and correlates of non-adherence to immunosuppressants and to health behaviours in patients after kidney transplantation in Brazil - the ADHERE BRAZIL multicentre study: a cross-sectional study protocol.

BACKGROUND: Non-adherence to immunosuppressive therapy is a prevalent risk factor for poor clinical and after kidney transplantation (KT), and has contributed to the lack of improvement in long-term graft survival over the past decade. Understanding the multilevel correlates and risk factors of non-adherence is crucial to determine the optimal level for planning interventions, namely at the patient, health care provider, KT centre, and health care system level. Brazil, having the largest public transplantation program in the world and with regional differences regarding access to health services and service implementation, is in a unique position to study this multilevel approach. Therefore, the Adhere Brazil Study (ADHERE BRAZIL) was designed to assess the prevalence and variability of non-adherence to immunosuppressants and to health behaviours among adult KT recipients in Brazil, and to assess the multilevel correlates of non-adherence to immunosuppressive medication. We describe the rationale, design, and methodology of the ADHERE BRAZIL study. METHODS/DESIGN: This is an observational, cross-sectional, multicentre study that includes 20 Brazilian KT centres. A stratified sampling approach is used, based on strata, with the following characteristics considered: geographical region and transplant activity (number of KTs per year). A random sample of patients (proportional to the size of the centre within each stratum) is selected from each centre. The prevalence of different health behaviours is assessed through self-report. The assessment of multilevel correlates of non-adherence is guided by the ecological model that considers factors at the level of the patient, health-care professional, and transplant centre, using established instruments or instruments developed for this study. Data will be collected over an 18-month period, with information obtained during the regular follow-up visits to the transplant outpatient clinic and directly entered into the Research Electronic Data Capture (RedCap) system. Data entry is performed by a trained professional who is part of the transplant team. The data collection began in December 2015. DISCUSSION: This multicentre study is the first to evaluate multilevel correlates of non-adherence in KT patients and will provide a reliable estimate of non-adherence in Brazilian KT patients. TRIAL REGISTRATION: ClinicalTrials.gov on 10/10/2013, NCT02066935 .

Pregnancy in renal transplant patients: Renal function markers and maternal-fetal outcomes.

OBJECTIVES: We aimed to evaluate laboratory markers in women who got pregnant after renal transplantation. STUDY DESIGN: Cross-sectional prospective study. MAIN OUTCOME MEASURES: Renal function parameters and maternal and fetal data were assessed in renal transplant recipients. RESULTS: Forty-three women who got pregnant after renal transplantation (mean age, 28.5 years; mean gestational age, 35.6 weeks) were included. Most patients (53.5%) received a renal transplant from a deceased donor. Podocyturia was not significantly correlated with other renal function markers. Mean period from transplantation to pregnancy was approximately 5 years; this period was not associated with obstetric complications or changes in renal markers. A gradual increase was observed in the following parameters during pregnancy and puerperium: serum creatinine levels (P < 0.001), proteinuria (P < 0.001), urinary protein/creatinine ratio (P < 0.001), and albumin/creatinine ratio (P < 0.001). The sensitivity and specificity of protein/creatinine ratio in predicting preeclampsia were high (96.0% and 94.0%, respectively). Elevated serum creatinine levels, urinary albumin/creatinine ratio, and retinol-binding protein levels in the third trimester were associated with prematurity (P < 0.001). Preeclampsia was the main cause of renal function decline at the end of pregnancy (65.0% of cases). Approximately four (9.5%) pregnant women presented with premature rupture of membranes and 18 (42.0%) with a urinary tract infection. CONCLUSIONS: Proteinuria, urinary protein/creatinine ratio, and retinol-binding protein levels were elevated in patients with preeclampsia. Using these markers to assess renal function during pregnancy may be clinically useful for detecting and monitoring renal injury in renal transplant recipients.