Prevalence of Chronic Kidney Disease (CKD) and Risk Factors in Sub-Saharan Africa (RenalOne)

CKD Prevalence and the Role of Cardiovascular Risk Factors and Infectious Diseases in a Region of Sub-Saharan Africa

Prospective cross-sectional study at the outpatient clinic (OPC) of the Bagamoyo District Hospital (BDH) in Tanzania. Assessment of basic epidemiological data (Point prevalence and risk factors) on CKD with simple clinical, laboratory tests and the patients history. After informed consent blood samples are taken for complete blood count, serum creatinine, HbA1c, HIV-Screening, and urine samples for dipstick, urine sediment, and albumin-creatinine ratio. Further, office blood pressure, weight and height are taken. Further, patients history are asked by a questionnaire (i.e.history of infectious and cardiovascular diseases and basic demographic data: i.e. sex, age).

CKD is defined as the presence of either impaired kidney function and/or albuminuria based on a one-time measurement.

Primary outcome of the study are prevalence rates of CKD and the impact of non-communicable and communicable disorders on CKD.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Hypertension; Diabetes Mellitus; Chronic Kidney Diseases; Tuberculosis; Schistosomiasis
• Intervention / Treatment: Diagnostic test: estimated glomerular filtration rate and albuminuria

Detailed Description

Study population and Setting:

Single centre cross-sectional study at the outpatient clinic (OPC) of the Bagamoyo District Hospital (BDH) in Tanzania. The BDH is located in Bagamoyo township on the coast of the Indian Ocean and provides care for a semi-rural population. After informed consent, all patients ≥ 18 years, irrespective of the reason of consultation, are included. Pregnant women and patients who are not able or willing to provide an informed signed consent are excluded.

Measurements and procedures:

All data are collected in a case report form, translated from English to Swahili. In all participants body weight and height, blood pressure, heart rate and temperature are recorded. After informed consent, a blood sample is taken for complete blood count and serum creatinine. Complete blood count is performed by a Sysmex Xs 800i analyser. Serum creatinine is measured using Creatinine Jaffe Gen2 reagent on a Cobas Integra 400 plus analyser. HbA1c is measured from capillary blood by using a bed-side DCA 2000+ Analyzer (Siemens Healthcare Diagnostics). After informed consent, HIV-screening is done with an immunochromatographic test for antibodies to HIV-1 and HIV-2 (test kits: Uni-Gold TM HIV, Trinity Biotech, Ireland; Determine® HIV-1/2, Inverness Medical Japan, Japan; SD BIOLINE HIV-1/2 3.0, SD Standard Diagnostics, Korea).

All participants are instructed to void a clean-urine specimen. Urine samples are prepared for microscopic analysis. Albumin-to- creatinine ratio (ACR) is measured using a DCA 2000+ analyser (Siemens Healthcare Diagnostics). CKD is defined as the presence of either impaired kidney function and/or albuminuria based on a one-time measurement. When one-time measurements are used, prevalence of reduced glomerular filtration rate (GFR) and albuminuria might be overestimated due to physiological variation and temporarily elevated values after physical activity and during acute illness or dehydration. Nevertheless, one-time measurements have been used for screening and epidemiologic purposes, as longitudinal documentation is not usually available in epidemiological studies. Kidney function is assessed by eGFR using the CKD-EPI formula. CKD is defined as an eGFR of <60 ml/min/1.73m2 and/or an ACR of ≥30mg/g (≥3 mg/mmol) and categorized according to Kidney Disease: Improving Global Outcomes (KDIGO) stages. Office BP is assessed by a single measurement using a manual sphygmomanometer in a sitting position after 5 minutes at rest. Systolic and diastolic BP is classified as normal (<120/<80 mmHg), pre-hypertensive (120-139/80-89 mmHg), hypertensive stage 1 (140-159/90-99 mmHg) or hypertensive stage 2 (≥160/≥100 mmHg) in analogy to the cut-off values of the JNC 7 report. Anaemia is defined as Hb <13.0 g/dl in male and <12.0 g/dl in female patients. Diabetes mellitus is defined as a history of diabetes, the use of antidiabetic medication or a HbA1c of ≥ 6.5%.

• Study Type: Observational
• Enrollment (Actual): 1006

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Single centre cross-sectional study at the outpatient clinic (OPC) of the Bagamoyo District Hospital (BDH) in Tanzania. The BDH is located in Bagamoyo township on the coast of the Indian Ocean and provides care for a semi-rural population. After informed consent, all patients ≥ 18 years, irrespective of the reason of consultation, were included. Pregnant women and patients who were not able or willing to provide an informed signed consent were excluded.

Description

Inclusion Criteria:

• ≥18 years

Exclusion Criteria:

• pregnant
• not able or willing to provide an informed signed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point prevalence of chronic kidney disease measured by lab values	Measured by serum-creatinine, albuminuria and calculation of estimated glomerular filtration rate (eGFR: serum-creatinine, age, weight, sex)	once measured at baseline, point prevalence

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for chronic kidney disease measured by lab values and questionnaire	measurement of HbA1c, haemoglobin, body mass index, sex, age, blood pressure, HIV screening; Questionnaire: patient history of tuberculosis, schistosomiasis, urinary tract infection, known HIV status	once measured at baseline

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Swiss Tropical & Public Health Institute; Ifakara Health Institute
• Investigators: Principal Investigator: Michael Mayr, MD, University Hospital Basel, Basel

Publications and helpful links

General Publications

• Hodel NC, Hamad A, Reither K, Mwangoka G, Kasella I, Praehauser C, Abdulla S, Hatz CFR, Mayr M. Assessment of diabetes and prediabetes prevalence and predictors by HbA1c in a population from sub-Saharan Africa with a high proportion of anemia: a prospective cross-sectional study. BMJ Open Diabetes Res Care. 2020 May;8(1):e000939. doi: 10.1136/bmjdrc-2019-000939.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2010
• Primary Completion (Actual): May 30, 2011
• Study Completion (Actual): May 30, 2011

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: chronic kidney disease; Tanzania; prevalence; sub-Saharan Africa; neglected disease; communicable disease; double burden
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Renal Insufficiency; Vector Borne Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Parasitic Diseases; Mycobacterium Infections; Helminthiasis; Trematode Infections; Kidney Diseases; Renal Insufficiency, Chronic; Tuberculosis; Schistosomiasis
• Other Study ID Numbers: RenalOne

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No