Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi to Inform Interventions for Earlier Detection and Prevention (Impso Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Aim 1, objective 1 primary outcome measure:
研究概览
简要总结
Worldwide, the number of people living with long-term health conditions, including chronic kidney disease (CKD), is increasing. CKD is usually asymptomatic in early stages but can progress to advanced disease, including kidney failure, causing significant morbidity and mortality.
In low-income countries of sub-Saharan Africa, including Malawi, treatments for kidney failure are not yet widely available and are prohibitively expensive . It is therefore vital to:
(a) Prevent development of CKD in the first place (b) Detect CKD earlier so that more cost-effective treatments can be given to slow progression.
There is little evidence on factors that drive CKD progression in Malawi, or on interventions that may be cost-effective for improving detection and slowing disease progression in this setting. This PhD will address these knowledge gaps, through the following aims:
- Determine the mortality associated with CKD, and the risk factors driving its development and progression in Malawian adults 2) Investigate the impacts of different models for integrating screening and prevention strategies for CKD and its risk factors into health services for other long-term conditions in low- and middle-income countries 3) With patients, carers, healthcare workers and policy makers, evaluate the feasibility and acceptability of different potential models for integrating CKD screening and prevention strategies into health services for high-risk patient groups in Malawi
详细描述
Background:
CKD prevalence is rising most rapidly in sub-Saharan Africa (current estimates 13-15%), where health systems are least equipped to tackle it (1-7). Malawi has only one nephrologist for a population of over 19 million and kidney replacement therapy (KRT), which consumes disproportionate healthcare spending, remains extremely limited (8,9).
Historically there has been insufficient data on CKD in LMICs owing to difficulties accessing diagnostics and uncertainty regarding the most appropriate context-specific methods for estimating kidney function (10).
Recent research by the African Research on Kidney Disease (ARK) group using measured GFR has shown that previous creatinine-based estimates significantly underestimated CKD burden in many African countries; in Malawi prevalence of eGFR <90ml/min/1.73m2 may be 51%, and eGFR <60ml/min/1.73m2 as high as 11.9% (6).
CKD has many causes, impacting on the public health strategies required to tackle it; however data on its underlying causes in Malawi and other countries of low-income Africa remain limited.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 18 years at time of participation in 2013-16 NCD survey
- •Living in one of the demographic surveillance sites (Chilumba, Karonga or Lilongwe area 25)
- •Creatinine +/- cystatin C result available from serum sample taken in 2013-16 NCD survey
排除标准
- •Child (age <18 years)
- •Not living in one of the study areas
- •Aim 1, Objective 2 (retrospective cohort study)
- •Inclusion criteria:
- •eGFRcreat ≥60ml/min/1.73m3 at baseline (using creatinine tested on serum sample from 2013-16 survey)
- •Participated and provided blood (serum) sample in 2022-25 long-term conditions (LTC) survey i.e. individual-level longitudinal paired serum samples available, including consent already given for testing of stored samples in future studies
- •Exclusion Criteria:
- •Child (age <18 years)
- •Not living in one of the study areas
- •Not consented previously to storage of blood samples and use of samples in future studies
- •Aim 1, Objective 3
- •Inclusion criteria:
- •As for Objective 1, PLUS:
- •eGFRcystC <90ml/min/1.73m3 at baseline (using cystatin C tested on 2013-16 serum sample)
- •Participated and provided serum sample in 2022-25 long-term conditions (LTC) survey i.e. individual-level longitudinal paired serum samples available
- •Still alive and living in one of the demographic surveillance sites
- •Able to provide consent or assent with consent from an appropriate nominated guardian
- •Exlusion criteria:
- •Declines consent
- •Unable to consent or assent
- •Children (<18 years)
- •Non-resident in study areas
- •Acute physical or mental illness
- •Hospital inpatient
- •Hospital admission >24 hours in past 90 days and <90 days until study end
- •Currently pregnant
结局指标
主要结局
Aim 1, objective 1 primary outcome measure:
时间窗: Deaths reported over maximum 10 year time period (time of inclusion in NCD study, 2013-16, to time of analysis, 2023)
• All-cause mortality rate per 1000 person-years at risk (adjusted for age, sex, key comorbidities)
Aim 1, objective 3 primary outcome measure
时间窗: Over duration of follow-up (2013 to 2025, average around 7.5 years)
25% reduction in eGFRcystC from baseline AND change in eGFRcystC category
Aim 1, objective 2 primary outome measure
时间窗: Over duration of follow-up (2013 to 2025, average around 7.5 years)
Development of eGFRcreat \<60ml/min/1.72m2
次要结局
- Aim 1, objective 3 secondary outcome measure 2:(Over duration of follow-up (2013 to 2025, average around 7.5 years))
- Aim 1, objective 3 secondary outcome measure 3:(Over duration of follow-up (2013 to 2025, average around 7.5 years))
- Aim 1, objective 3 secondary outcome measure 6:(Over duration of follow-up (2013 to 2025, average around 7.5 years))
- Aim 1, objective 3 secondary outcome measure 1:(Over duration of follow-up (2013 to 2025, average around 7.5 years))
- Aim 1, objective 3 secondary outcome measure 4:(Over duration of follow-up (2013 to 2025, average around 7.5 years))
- Aim 1, objective 3 secondary outcome measure 5:(Over duration of follow-up (2013 to 2025, average around 7.5 years))
- Aim 1, objective 2 secondary outcome measure:(Over duration of follow-up (2013 to 2025, average around 7.5 years))
- Aim 1, objective 1 secondary outcome measure:(Deaths reported over maximum 10 year time period (time of inclusion in NCD study, 2013-16, to time of analysis, 2023))