Chronic kidney disease (CKD) is associated with increased cardiovascular morbidity and mortality. The prevalence of CKD is increasing worldwide and is assumed to also dramatically increase in Sub-Saharan Africa (SSA). Key shortcomings of available data on CKD in SSA are as follows: (i) Available data are based on single measurements and, therefore, cannot distinguish between harmless transient deterioration in kidney function and chronic kidney damage; (ii) Accurate information regarding renal protein loss, an important and early marker of kidney disease, is lacking; (iii) Cardiovascular risk factors for CKD, such as obesity, hypertension and diabetes, are often not searched for. Likewise non-classic potential risk factors, such as endemic infectious diseases, socioeconomic status and lifestyle have not been consistently recorded; (iv) Information to interrogate linked interaction over time between risk factors and development of CKD is unavailable. With this project, situated in a region representative of semi-rural SSA, we aim to fill this knowledge gap and (i) establish guideline conform prevalence data of CKD and its major cardiovascular risk factors, as well as (ii) prospectively define the incidence of cardiovascular- and non-classic risk factors of CKD. The data from (i) and (ii) is used to develop predictive models. A prospective cohort of 1200 individuals in a primary care facility will serve as study population. The population is representing a society in transition from rural to more urban lifestyle. In the pilot study, participants will be followed for one years and undergo the clinical and biomedical testing required to capture CKD and its classic and non-classic risk factors over time.
None
<18 years of age
not living in the BDH catchment area
not of African decent
not willing to come back for follow-up visits
Adult walk-in patients in a primary care setting from the Bagamoyo district hospital (BDH) catchment area attending the outpatient clinic (OPC) or the Fukayosi or Yombo dispensary.
Cohort
Prospective
Not listed
Chronic kidney disease (CKD) prevalence rates
Assessment of serum creatinine: umol/L; Device/Test: Roche Combas Integra 400 plus device using Creatinine Jaffe Gen2 serum test, Roche Diagnostics Switzerland estimated glomerular filtration (eGFR) is calculated using the CKD-EPI 2021 formula: ml/min/1.73m2; Assessment of albumin-to-creatinine ratio (ACR): mg/g; Device/Test: Abbott Affinion 2 Analyzer using Affinion ACR Test, Abbott USA CKD is defined and staged according to Kidney Disease: Improving Global Outcomes (KDIGO) guidelines using eGFR and ACR; Prevalence is reported in percentages with respective 95% confidence Intervals (CI) using Sison-Glaz methods; Prevalence is reported overall and according to KDIGO staging
Prevalence of cardiovascular and non-classic risk factors of CKD
Biological and clinical assessed: Albuminuria , kidney function, (creatinine, cystatin C, eGFR), CKD stages (KDIGO) Prevalence is reported as percentage with respective 95% CI using respective statistical methods as described above.
Incidence of chronic kidney disease (CKD) and cardiovascular- and non-classic risk factors of CKD:
Repeated assessment of biological and clinical parameters as described in Outcome 2 are used to determine the incidence of CKD and its cardiovascular- and non-classic risk factors Incidence is reported as percentage increase between respective time points (from baseline visit at day of enrolment, and/or to confirmation visit after ≥90days visit and/or to first follow-up visit after one year) with respective 95% CI using respective statistical methods as described above.
Incidence of cardiovascular- and non-classic risk factors of CKD:
Repeated assessment of biological and clinical parameters as described in Outcome 2 are used to determine the incidence of cardiovascular- and non-classic risk factors of CKD Incidence is reported as percentage increase between respective time points (from baseline visit at day of enrolment, and/or to confirmation visit after ≥90days visit and/or to first follow-up visit after one year) with respective 95% CI using respective statistical methods as described above.
Longitudinal assessed concordance and usefulness of glycated hemoglobin A1c (HbA1c) in patients with anaemia
Device/Test: Abbott Affinion 2 Analyzer using Affinion HbA1c Test, Abbott USA Classification: \< 5.7% no-diabetes, 5.7- 6.49% pre-diabetes, ≥ 6.5% diabetes Concordance is assessed using area under the curve AUC description and correlation plots with respective statistics
Validation of semi-quantitative colorimetric urine dipstick test in diagnosis of albuminuria in a setting with repeated measurement
Albuminuria: Cut-off ACR gold standard test: ≥ 30mg/g Negative and positive predictive values and usability for albuminuria screening in setting of repeated measurement. The higher (%) the sensitivity, specificity and predictive values the more likely the index test is accurately testing the same as the gold-standard test
Assessment of lipid profile for incidence
Device/Test: Abbott Affinion 2 Analyzer using Affinion Lipid panel Test, Abbott USA: mmol/L Reference ranges Total cholesterol: 3.0 - 5.2 mmol/L; LDL: 1.60-3.40 mmol/L; HDL: 0.90-2.20 mmol/L; Triglycerides: \<1.70 mmol/L; Cholesterol/HDL-Cholesterol: 2.34-5.0 ratio
Assessment of Hypertension incidence
Device: A\&D Medical UA 651BLE digital blood pressure monitor; mmH Staged and classified according to international guidline.
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Swiss Tropical & Public Health Institute
Lead sponsor
University Hospital, Basel, Switzerland
Collaborator
Ifakara Health Institute
Collaborator
