Chronic Kidney DiseasesRenalOneNCT03458338
Prevalence of Chronic Kidney Disease (CKD) and Risk Factors in Sub-Saharan Africa
An observational study of Chronic Kidney Diseases and Diabetes Mellitus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Kidney Diseases, Diabetes Mellitus, Hypertension
- What is being tested?
- estimated glomerular filtration rate and albuminuria
- How many people
- 1,006 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Dec 2010to 30 May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥18 years
Who cannot join
- pregnant
- not able or willing to provide an informed signed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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%.
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Hypertension, Tuberculosis, Schistosomiasis, HIV Infections
- Being tested
- estimated glomerular filtration rate and albuminuria
- Keywords
- chronic kidney disease, communicable disease, sub-Saharan Africa, Tanzania, neglected disease, prevalence, double burden
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Hypertension, Tuberculosis, Schistosomiasis, HIV Infections, Communicable Diseases, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estimated glomerular filtration rate and albuminuriaDiagnostic test
chronic kidney disease according to KDIGO
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: once measured at baseline, point prevalence
Secondary outcomes (1)
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
Measured: once measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start8 Dec 2010
- Primary completion30 May 2011
- Study completion30 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Ifakara Health Institute
- Responsible party
- Sponsor
- Investigators
- Michael Mayr, MD, Principal investigator, University Hospital Basel, Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458338
- Sponsor's protocol ID
- RenalOne
- Acronym
- RenalOne
- Status last verified
- Mar 2018
- First submitted
- 1 Mar 2018
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32439737
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CKD Prevalence and the Role of Cardiovascular Risk Factors and Infectious Diseases in a Region of Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT03458338
- Acronym / sponsor ID
- RenalOne / RenalOne
- Conditions
- Chronic Kidney Diseases, Diabetes Mellitus, Hypertension, Tuberculosis, Schistosomiasis, HIV Infections
- Keywords
- chronic kidney disease, communicable disease, sub-Saharan Africa, Tanzania, neglected disease, prevalence, double burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,006 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Ifakara Health Institute
- Study start
- 8 Dec 2010 (actual)
- Primary completion
- 30 May 2011 (actual)
- Study completion
- 30 May 2011 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- ≥18 years
Key exclusion criteria (2 listed)
- pregnant
- not able or willing to provide an informed signed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| estimated glomerular filtration rate and albuminuriachronic kidney disease according to KDIGO | Diagnostic test | – |
Primary outcome
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)
1 secondary outcome
Risk factors for chronic kidney disease measured by lab values and questionnaire
Time frame: once measured at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Derived from this study: PubMed 32439737Hodel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Mayr, MD principal investigator
University Hospital Basel, Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Diabetes Mellitus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence of chronic kidney disease measured by lab values (time frame: once measured at baseline, point prevalence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.