Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi (NCT06312072) | Clinical Trial Compass
UnknownNot Applicable
Understanding Risk Factors for Progressive Chronic Kidney Disease in Malawi
Malawi1,100 participantsStarted 2024-02-14
Plain-language summary
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:
1\) 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Aim 1, Objective 1 (survival analysis):
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 conse…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Aim 1, objective 3 primary outcome measure
Timeframe: Over duration of follow-up (2013 to 2025, average around 7.5 years)
2
Aim 1, objective 2 primary outome measure
Timeframe: Over duration of follow-up (2013 to 2025, average around 7.5 years)
3
Aim 1, objective 1 primary outcome measure:
Timeframe: Deaths reported over maximum 10 year time period (time of inclusion in NCD study, 2013-16, to time of analysis, 2023)