Clinical trial
Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in Sub-Saharan Africa
Recruiting now · Not applicable · 1 countries · Registry ID NCT05881447
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
Primary outcomes
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
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.
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.
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.
Study locations
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