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

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ClinicalTrials.gov Identifier: NCT03458338
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
Swiss Tropical & Public Health Institute
Ifakara Health Institute
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

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.


Condition or disease Intervention/treatment
Chronic Kidney Diseases Diabetes Mellitus Hypertension Tuberculosis Schistosomiasis HIV Infections 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
Actual Enrollment : 1006 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: CKD Prevalence and the Role of Cardiovascular Risk Factors and Infectious Diseases in a Region of Sub-Saharan Africa
Actual Study Start Date : December 8, 2010
Actual Primary Completion Date : May 30, 2011
Actual Study Completion Date : May 30, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases


Intervention Details:
  • Diagnostic Test: estimated glomerular filtration rate and albuminuria
    chronic kidney disease according to KDIGO


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


Secondary Outcome Measures :
  1. Risk factors for chronic kidney disease measured by lab values and questionnaire [ Time Frame: once measured at baseline ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • ≥18 years

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458338


Locations
Switzerland
Universitätsspital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss Tropical & Public Health Institute
Ifakara Health Institute
Investigators
Principal Investigator: Michael Mayr, MD University Hospital Basel, Basel

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03458338     History of Changes
Other Study ID Numbers: RenalOne
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
chronic kidney disease
communicable disease
sub-Saharan Africa
Tanzania
neglected disease
prevalence
double burden

Additional relevant MeSH terms:
Schistosomiasis
Diabetes Mellitus
HIV Infections
Kidney Diseases
Renal Insufficiency, Chronic
Tuberculosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Urologic Diseases
Renal Insufficiency
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Trematode Infections
Helminthiasis
Parasitic Diseases