"Residual Kidney Function and Oxidative Stress in Incremental vs Standard Peritoneal Dialysis (2 Mexican Centers)"

NCT07338435 | Active Not Recruiting

• 1 other identifier: R-2024-1009-44
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension With Renal Dysfunction; Chronic Kidney Disease; Diabetic Kidney Disease; Peritoneal Dialysis (PD); Hypertension

Keywords

inflammation.; chronic kidney disease.; oxidative stress; malondialdehyde; residual kidney function; incremental peritoneal dialysis; peritoneal dialysis

Outcome Measures

Primary Outcomes (2)

• Oxidative stress Serum malondialdehyde (MDA) levels

  Oxidative stress will be assessed by serum malondialdehyde (MDA) concentration measured as thiobarbituric acid-reactive substances (TBARS) using spectrophotometry at 532 nm. Results will be expressed in nmol/mL.

  Baseline and 12 months

• Residual kidney function

  Residual kidney function will be evaluated by estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation (mL/min/1.73 m²), 24-hour, 24-hour urine volume (liters), and 24-hour creatinine clearance (mL/min).

  Baseline, 45 days, 3 months, 6 months, 9 months, and 12 months

Secondary Outcomes (2)

• Systemic inflammation: Inflammatory biomarkers

  at 3, 6,9, and 12 moths

• Catheter-related outcomes

  Up to 12 months

Study Arms (2)

Incremental peritoneal dialysis (IPD)

EXPERIMENTAL

uses reduced dialysis doses less exchanges, generally 3 or less

Procedure: Incremental Peritonal Dialysis

Standard peritoneal dialysis (SPD)

ACTIVE COMPARATOR

standard peritoneal dialysis (SPD)-which typically involves four daily exchanges of 4-5 hours each one with night exchange, known too like full-dose dialysis

Procedure: Standard Peritoneal Dialysis

Interventions

Standard Peritoneal Dialysis PROCEDURE

4 exchanges with nocturnal dwell.

Also known as: DPCA

Standard peritoneal dialysis (SPD)

Incremental Peritonal Dialysis PROCEDURE

lower dialysis doses based on RKF, generally 3 exchanges or less.

Also known as: IPD

Incremental peritoneal dialysis (IPD)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CKD adults starting on PD FKR ≥2 mL/min Urine Volumen ≥500 mL/24 hrs Type 2 Diabetes, Hypertension and unknown cause of CKD

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidad de Guanajuato: collaborator
• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Instituto Mexicano del Seguro Social

León, Guanajuato, 37296, Mexico

Location

Related Publications (3)

• Basso A, Baldini P, Bertoldi G, Driussi G, Caputo I, Bettin E, Cacciapuoti M, Calo LA. Oxidative stress reduction by icodextrin-based glucose-free solutions in peritoneal dialysis: Support for new promising approaches. Artif Organs. 2024 Sep;48(9):1031-1037. doi: 10.1111/aor.14801. Epub 2024 Jun 1.

  PMID: 38822597 BACKGROUND

• Kunin M, Beckerman P. The Peritoneal Membrane-A Potential Mediator of Fibrosis and Inflammation among Heart Failure Patients on Peritoneal Dialysis. Membranes (Basel). 2022 Mar 11;12(3):318. doi: 10.3390/membranes12030318.

  PMID: 35323792 BACKGROUND

• Blake PG, Dong J, Davies SJ. Incremental peritoneal dialysis. Perit Dial Int. 2020 May;40(3):320-326. doi: 10.1177/0896860819895362. Epub 2020 Jan 17.

  PMID: 32063212 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetic Nephropathies; Hypertension; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical prophesor

Model Details: The researchers will assign the participants by lottery using a table of numbers to each of the incremental or standard dialysis treatments, forming groups A and B. To form the treatment groups, the options will be A: Incremental peritoneal dialysis (IPD) and B: Standard peritoneal dialysis (standard PD or CAPD). A probabilistic number will be determined using block randomization, so the group will be divided into 10 blocks of 4 patients each, assigning 2 to group A and 2 to group B.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 13, 2026
• Study Start: November 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD and supporting documents will be available starting 6 months after publication of the primary results and will remain accessible for 5 years.
• Access Criteria: Access to de-identified IPD will be granted to qualified researchers with a methodologically sound proposal, subject to IRB approval and a signed data use agreement. Requests must be submitted via email to the principal investigator. Data will be shared through secure electronic means.

Locations

ME (1)