Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in Sub-Saharan Africa

NCT05881447 | Recruiting

• 1 other identifier: HSR-2022-27
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Type 2 Diabetes Mellitus; Arterial Hypertension; Obesity; Cardiovascular Diseases; HIV Infections; Anemia; Underweight; Infections; Albuminuria; Dyslipidemias

Keywords

CKD; Risk factors; Cardiovascular disease; Anemia; Point of care diagnostics; Albumin creatinine ration (ACR); Estimated glomerular filtration rate (eGFR); Kidney Disease: Improving Global Outcomes (KDIGO); HbA1c

Outcome Measures

Primary Outcomes (4)

• 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

  18 months

• 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.

  18 months

• 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.

  18 months

• 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.

  18 months

Secondary Outcomes (4)

• Longitudinal assessed concordance and usefulness of glycated hemoglobin A1c (HbA1c) in patients with anaemia

  18 months

• Validation of semi-quantitative colorimetric urine dipstick test in diagnosis of albuminuria in a setting with repeated measurement

  18 months

• Assessment of lipid profile for incidence

  18 months

• Assessment of Hypertension incidence

  18 months

Study Arms (1)

RenalTWO screening cohort

Approximately 1200 patients seeking primary care in the Bagamoyo District Hospital and in two of its associated dispensaries are randomly selected to participate in the RenalTWO cohort study. This includes a longitudinal health check-up over three visits: at the date of enrolment, after a minimum of 90 days for confirmation, and finally after one full calendar year.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• all adult patients (≥18 years) attending the outpatients department of the Bagamoyo district hospital (BDH) or the associated Fukayosi and Yombo dispensary

You may not qualify if:

• \<18 years of age
• not living in the BDH catchment area
• not of African decent
• not willing to come back for follow-up visits

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• University Hospital, Basel, Switzerland: collaborator
• Ifakara Health Institute: collaborator

Study Sites (1)

Bagamoyo District Hospital

Bagamoyo, Coast Region, Tanzania

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine Serum Plasma only of patients who have given explicit consent for biospecimen retention

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2; Hypertension; Obesity; Cardiovascular Diseases; HIV Infections; Anemia; Thinness; Infections; Albuminuria; Dyslipidemias

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Lipid Metabolism Disorders

Study Officials

• Michael Mayr, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Daniel H Paris, Prof

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

• Nikolai C Hodel, MSc

  Swiss Tropical & Public Health Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolai C Hodel, MSc

CONTACT

+255762768035; nikolai.hodel@swisstph.ch

Ally Olotu, PhD

CONTACT

+255718927104; aolotu@ihi.or.tz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: June 21, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

TA (1)