Modified versus conventional CAPD for children with end-stage kidney disease in low-resource settings
A Multicenter Study Comparing Conventional Continuous Ambulatory Peritoneal Dialysis Prescription (C-CAPD) With Modified-CAPD (M-CAPD) Prescription in Delivering High Quality Goal-directed Peritoneal Dialysis in Children With End-stage Kidney Disease From Low-resource Settings: MaxED-OUT Trial
NA · National University Health System, Singapore · NCT07134595
This project will test whether a modified CAPD schedule (M-CAPD) helps children aged 2 to ≤18 with end-stage kidney disease get better fluid removal and solute clearance while reducing peritoneal dialysis fluid waste.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | National University Health System, Singapore (other) |
| Locations | 1 site (Manila, Ermita) |
| Trial ID | NCT07134595 on ClinicalTrials.gov |
What this trial studies
This randomized crossover study enrolls children aged 2 to ≤18 years with end-stage kidney disease on peritoneal dialysis for at least three months to compare a modified manual CAPD prescription (M-CAPD) with conventional CAPD (C-CAPD) over one year. M-CAPD adapts principles from adapted APD by combining short, low-volume exchanges with longer, higher-volume dwells to improve ultrafiltration and solute clearance without requiring automated machines. Key outcomes include 24-hour ultrafiltration, bioimpedance-measured fluid overload, residual urine output, glucose exposure, medication changes, caregiver burden, and PD fluid waste. Participants are randomized to treatment sequence and crossover to the alternate prescription, with procedures at collaborating centers in Southeast Asia including Philippine General Hospital.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 18 years with end-stage kidney disease who have been on peritoneal dialysis for at least three months and have a body surface area below 1.5 m2 without recent peritonitis or mechanical PD complications.
Not a fit: Patients with peritoneal membrane failure, recent peritonitis, mechanical causes of ultrafiltration failure, or large body size (BSA ≥1.5 m2) are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, M-CAPD could improve fluid removal and toxin clearance in children while cutting peritoneal dialysis fluid waste and caregiver burden in low-resource settings.
How similar studies have performed: This approach is novel for manual CAPD—adapted APD methods have shown promise elsewhere, but applying those principles to CAPD in children has not been previously studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * CKD 5D who have been on peritoneal dialysis for at least three months. Exclusion Criteria: 1. Patients with BSA of ≥1.5 m2, 2. Evidence of mechanical causes of low ultrafiltration capacity (hernia, peri-catheter, or genital leaks, pleuroperitoneal communication), 3. Peritoneal membrane failure (encapsulating peritoneal sclerosis), 4. Recent episode of peritonitis (within two months) 5. Those who have been on hemodialysis before switching to PD in the last three weeks.
Where this trial is running
Manila, Ermita
- Philippine General Hospital — Manila, Ermita, Philippines (RECRUITING)
Study contacts
- Principal investigator: Hui Kim Yap, Professor — National University Health System, Singapore
- Study coordinator: Sharon Teo, Consultant
- Email: sharon_teo@nuhs.edu.sg
- Phone: +65 91678482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Children on Chronic Peritoneal Dialysis, M-CAPD, C-CAPD, ESKD, Children, Low-resource settings