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

Study acronym: RenalTWO
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026v6
  2. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2025v5
  3. Minor Re-verified, no change to tracked fieldsv4
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 19, 2023 to Jun 21, 2023 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Jun 19, 2023 to Jun 21, 2023
    • Site details revised
  5. Notable Primary completion date: Apr 1, 2024 to Dec 31, 2024 Primary endpoints: 2 to 4 · Completion date: Dec 30, 2024 to Dec 31, 2025 · Start date: Jun 1, 2023 to Jun 19, 2023 · 5 morev2 Show 8 more changesShow less
    • Primary endpoints: 2 to 4
    • Completion date: Dec 30, 2024 to Dec 31, 2025
    • Start date: Jun 1, 2023 to Jun 19, 2023
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints: 1 to 4
    • Study description expanded, about 312 words
    • Site contact updated
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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and 3 more diseases
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.
Trial Details
NCT Number NCT05881447
Lead Sponsor Swiss Tropical & Public Health Institute
Collaborators: University Hospital, Basel, Switzerland, Ifakara Health Institute
Conditions Chronic Kidney Diseases, Type 2 Diabetes Mellitus, Arterial Hypertension, Obesity, Cardiovascular Diseases, HIV Infections, Anemia, Underweight +3 more
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov