NCT07338435Active, not recruiting
"Residual Kidney Function and Oxidative Stress in Incremental vs Standard Peritoneal Dialysis (2 Mexican Centers)"
"Comparison of Preservation Residual Renal Function and Oxidative Damage Between Incremental and Standard Peritoneal Dialysis in Incident Patients at Two Centers of Mexico.
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
Title: Comparison of Oxidative Stress and Preservation of Residual Kidney Function Between Incremental and Standard Peritoneal Dialysis in Incident Patients at the Regional General Hospital No. 58 and HGZ/UMF 21 of the Mexican Institute of Social Security (IMSS) in León, Guanajuato BACKGROUND: Peritoneal dialysis (PD) employs hypertonic dextrose-based solutions to remove toxins and excess fluids. This exposure promotes mitochondrial overproduction of reactive oxygen species (ROS), triggers inflammation, and may accelerate the decline of residual kidney function (RKF), leading to complications such as peritonitis, peritoneal fibrosis, and technique failure. Although more biocompatible solutions are available, their high cost and limited accessibility restrict their use in our setting. Incremental peritoneal dialysis (IPD), in contrast to standard peritoneal dialysis (SPD)-which typically involves four daily exchanges with full-dose dialysis-uses reduced dialysis doses tailored to RKF, thereby decreasing glucose exposure. The primary aim of this study was to compare the effects of IPD versus SPD on oxidative stress, inflammation, and the preservation of residual kidney function in incident peritoneal dialysis patients at the Regional General Hospital No. 58 in León, Guanajuato. MATERIALS AND METHODS: A prospective, longitudinal, single-center, open-label, randomized clinical trial will be conducted. Incident peritoneal dialysis patients at the Regional General Hospital No. 58 and Gneral Hospital of Zone Numbre 21 of the Mexican Institute of Social Security (IMSS) who meet the inclusion criteria and provide informed consent will be randomly assigned to either the standard or incremental peritoneal dialysis group. Acute-phase reactants will be measured at baseline and at 3, 6, 9, and 12 months. Oxidative stress will be assessed via baseline and end-of-study malondialdehyde levels. Dialysis and urine Kt/V will be evaluated betwen 6 weeks and 3 moths and 6, 9, and 12 months. Appropriate statistical analyses will be performed thereafter.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- Nov 2024
- Primary completion date
- Apr 2026
- Lead sponsor
- Instituto Mexicano del Seguro Social
- NCT number
- NCT07338435
What you commit to
- Study type: Interventional
- Planned participants: 100
- From Nov 2024 to the primary completion date, Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Self-reported smoking or active use of illicit drugs. Patients with liver disease. Patients with glomerulonephritis. Patients with a history of previous renal replacement therapy (hemodialysis or kidney transplant).
Who the study is looking for
- CKD adults starting on PD FKR ≥2 mL/min Urine Volumen ≥500 mL/24 hrs Type 2 Diabetes, Hypertension and unknown cause of CKD
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Mexicano del Seguro Social Coordinator of this site? Confirm its status | León | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.