Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:34 AM
Study NCT ID:
NCT07338435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Residual Kidney Function and Oxidative Stress in Incremental vs Standard Peritoneal Dialysis (2 Mexican Centers)"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.\n\nTo 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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxidative stress Serum malondialdehyde (MDA) levels', 'timeFrame': 'Baseline and 12 months', 'description': '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.'}, {'measure': 'Residual kidney function', 'timeFrame': 'Baseline, 45 days, 3 months, 6 months, 9 months, and 12 months', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Systemic inflammation: Inflammatory biomarkers', 'timeFrame': 'at 3, 6,9, and 12 moths', 'description': 'Systemic inflammation will be assessed by serum levels of C-reactive protein (CRP, mg/L), ferritin (ng/mL), albumin (g/dL), and D-dimer (ng/mL), measured using standardized laboratory methods.'}, {'measure': 'Catheter-related outcomes', 'timeFrame': 'Up to 12 months', 'description': 'Catheter outcomes will be assessed by time to first catheter-related complication or infection, expressed as complication-free catheter survival.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammation.', 'chronic kidney disease.', 'oxidative stress', 'malondialdehyde', 'residual kidney function', 'incremental peritoneal dialysis', 'peritoneal dialysis'], 'conditions': ['Chronic Kidney Disease', 'Diabetic Kidney Disease', 'Peritoneal Dialysis (PD)', 'Hypertension', 'Hypertension With Renal Dysfunction']}, 'referencesModule': {'references': [{'pmid': '38822597', 'type': 'BACKGROUND', 'citation': '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': '35323792', 'type': 'BACKGROUND', 'citation': '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': '32063212', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Title:\n\nComparison 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\n\nBACKGROUND:\n\nPeritoneal 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.\n\nIncremental 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.\n\nThe 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.\n\nMATERIALS AND METHODS:\n\nA 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.\n\nAcute-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.', 'detailedDescription': "Eligible incident peritoneal dialysis (PD) patients from two IMSS hospitals in León, Guanajuato (HGR No. 58 and HGZ-MF No. 21) will be enrolled after confirmation of adequate Tenckhoff catheter placement and written informed consent. Baseline demographic and clinical data will be collected from medical records and physical examination, including age, sex, marital status, educational level, anthropometric parameters (weight, height, body mass index), and volume status assessed by physical examination using the Godet edema scale.\n\nLaboratory evaluations will be performed in blood and urine. Fasting venous blood samples will be obtained for complete blood count, serum chemistry, electrolytes, lipid profile, inflammatory markers (albumin, ferritin, C-reactive protein, D-dimer), and viral serology (HBV, HCV, HIV). Oxidative stress will be assessed in serum by measuring thiobarbituric acid-reactive substances (TBARS) as an index of malondialdehyde concentration using a standardized spectrophotometric method.\n\nResidual renal function will be assessed at baseline and during follow-up (45 days, and 3, 6, 9, and 12 months) by estimated glomerular filtration rate (CKD-EPI equation), 24-hour urine volume, and 24-hour creatinine clearance. Solute clearance adequacy (renal and peritoneal Kt/V) will be measured at 1.5-3 months, 6 months, and 12 months. Peritoneal membrane transport characteristics will be evaluated at month 3 using the Peritoneal Equilibration Test (PET).\n\nParticipants will be randomized in a 1:1 ratio to Incremental Peritoneal Dialysis or Standard Peritoneal Dialysis using block randomization (blocks of four). Glucose exposure will be quantified based on dialysate glucose concentration and number of exchanges, expressed as bags per year. Catheter-related complications and infection-free catheter survival will be monitored throughout the 12-month follow-up. After completion of follow-up, patients will continue PD according to their treating nephrologist's prescription."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCKD adults starting on PD FKR ≥2 mL/min Urine Volumen ≥500 mL/24 hrs Type 2 Diabetes, Hypertension and unknown cause of CKD\n\nExclusion Criteria:\n\nSelf-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).'}, 'identificationModule': {'nctId': 'NCT07338435', 'acronym': 'INSPiRE', 'briefTitle': '"Residual Kidney Function and Oxidative Stress in Incremental vs Standard Peritoneal Dialysis (2 Mexican Centers)"', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': '"Comparison of Preservation Residual Renal Function and Oxidative Damage Between Incremental and Standard Peritoneal Dialysis in Incident Patients at Two Centers of Mexico.', 'orgStudyIdInfo': {'id': 'R-2024-1009-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Incremental peritoneal dialysis (IPD)', 'description': 'uses reduced dialysis doses less exchanges, generally 3 or less', 'interventionNames': ['Procedure: Incremental Peritonal Dialysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard peritoneal dialysis (SPD)', 'description': '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', 'interventionNames': ['Procedure: Standard Peritoneal Dialysis']}], 'interventions': [{'name': 'Standard Peritoneal Dialysis', 'type': 'PROCEDURE', 'otherNames': ['DPCA'], 'description': '4 exchanges with nocturnal dwell.', 'armGroupLabels': ['Standard peritoneal dialysis (SPD)']}, {'name': 'Incremental Peritonal Dialysis', 'type': 'PROCEDURE', 'otherNames': ['IPD'], 'description': 'lower dialysis doses based on RKF, generally 3 exchanges or less.', 'armGroupLabels': ['Incremental peritoneal dialysis (IPD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37296', 'city': 'León', 'state': 'Guanajuato', 'country': 'Mexico', 'facility': 'Instituto Mexicano del Seguro Social', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}]}, 'ipdSharingStatementModule': {'url': 'https://www.imss.gob.mx/investigacion', 'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'IPD and supporting documents will be available starting 6 months after publication of the primary results and will remain accessible for 5 years.', 'ipdSharing': 'YES', 'description': 'Database and Informed consent', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Universidad de Guanajuato', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical prophesor', 'investigatorFullName': 'Veronica Valdivia Cerda', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}