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Acute kidney injury progression to chronic kidney disease in children hospitalized with severe malaria

Malaria Associated Pathogenesis of Chronic Kidney Disease (MAP-CKD): a prospective study of acute kidney injury and chronic kidney disease in children hospitalized with severe malaria

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN10885288
Enrollment
1125
Registered
2025-05-21
Start date
2023-08-14
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease progression following severe malaria-associated acute kidney injury Urological and Genital Diseases

Interventions

This is a prospective observational cohort study that will recruit children with severe malaria through the emergency room of participating clinical sites (Mulago National Referral Hospital, Lira Regi

Sponsors

Indiana University Indianapolis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Severe malaria: 1. Aged between 90 days and <16 years of age 2. Require inpatient hospitalization 3. Have a clinical diagnosis of severe malaria supported by a positive rapid diagnostic test for Plasmodium falciparum HRP-2 antigen, or direct visualization of asexual parasites by microscopy. Community children: 1. Aged between 90 days and <16 years of age 2. Live in the same or neighboring household as a child with severe malaria

Exclusion criteria

Exclusion criteria: Severe malaria: 1. Children on maintenance dialysis or known to have chronic kidney disease 2. The presence of congenital heart disease, pre-existing neurological disease or cerebral palsy 3. Enrollment in another study that may affect participation Community children: 1. The same as those for children with severe malaria, but also include a previous hospitalization 1. A history of illness requiring medical treatment or medication use in the previous four weeks 3. Evidence of fever or active illness on physical examination

Design outcomes

Primary

MeasureTime frame
Chronic kidney disease (CKD), defined as an eGFR <90 ml/min/1.73 m2 using the U25 eGFR formula or age-specific albuminuria sustained over 3 months, measured at at 1, 2, 4, 12, 24 months

Secondary

MeasureTime frame
1. Hypertension (stage 2) (systolic or diastolic blood pressure of 99% or >140/90 mmHg) at scheduled follow-up visits at 1, 2, 4, 12 and 24 months 2. Acute kidney disease (AKD), defined as AKI present for more than 7 days or the presence of low eGFR at scheduled follow-up visits at 1, 2, 4, 12 and 24 months 3. Cognitive deficits measured using the Kaufman Assessment Battery for Children, Second Edition (KABC-II) at 12 and 24 months follow-up 4. Behavioral problems measured using the Child Behavior Checklist (CBCL) at 12 and 24 months follow-up 5. Cerebral edema, defined using apparent diffusion coefficient maps of Magnetic Resonance Images during hospitalization 6. Health-related quality of life measured using the Pediatric Quality of Life Inventory (PedsQL) over scheduled follow-up visits at 1, 2, 4, 12 and 24 months 7. Post-discharge mortality based on parental report over the 24-month follow-up period. 8. Hyperfiltration, defined as sustained eGFR >180 ml/min per 1.73m2, using serum creatinine over follow-up

Countries

Uganda

Contacts

Public ContactAndrea Conroy
conroya@iu.edu+1 3172748940

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026