Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-05 @ 10:51 PM
Study NCT ID:
NCT07474805
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Renal Replacement in Mexico
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 290}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'From enrollment in the study until death from any cause or end of follow-up, assessed up to 3 years.', 'description': "The occurrence of death from any cause during the follow-up period, as documented in the patient's medical record"}], 'secondaryOutcomes': [{'measure': 'Hospitalizations per patient-year', 'timeFrame': 'From enrollment until the end of follow-up, assessed up to 3 years', 'description': 'The number of hospitalizations recorded during the study follow-up, expressed per patient-year'}, {'measure': 'Infection rate', 'timeFrame': 'From enrollment until the end of follow-up, assessed up to 3 years', 'description': 'The number of documented infection episodes during the follow-up period, as recorded in the medical records, expressed per patient-year.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'Renal replacement therapy', 'Clinical outcomes'], 'conditions': ['Chronic Kidney Disease - Stage V', 'Chronic Kidney Disease on Hemodialysis']}, 'descriptionModule': {'briefSummary': 'A descriptive, observational, prospective, multicenter study aimed at describing the main clinical outcomes of patients with chronic kidney disease receiving any form of renal replacement therapy in Mexico.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic kidney disease undergoing hemodialysis or peritoneal dialysis in the units participating in the project', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to participate and provision of written informed consent\n* Diagnosis of chronic kidney disease and treatment with hemodialysis or peritoneal dialysis for ≥3 months\n* Availability of a medical record containing information on the study variables\n* Receiving care at one of the participating centers\n\nExclusion Criteria:\n\n* Life expectancy \\<3 months due to a cause unrelated to chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT07474805', 'acronym': 'ORReMex', 'briefTitle': 'Outcomes of Renal Replacement in Mexico', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Clinical Outcomes Study of Mexican Patients With Chronic Kidney Disease on Renal Replacement Therapy', 'orgStudyIdInfo': {'id': 'NMM-5533-25-28-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD on RRT', 'description': 'Patients with chronic kidney disease undergoing renal replacement therapy (RRT) in Mexico'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Olynka Vega Vega, MD, MSc', 'role': 'CONTACT', 'email': 'olynkavega@hotmail.com', 'phone': '+5215548039428'}, {'name': 'Yazmin Alejandra Mercado Hernandez, MD', 'role': 'CONTACT', 'email': 'yazale1992@hotmail.com', 'phone': '+5215520353821'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It has not yet been determined whether individual participant data will be shared. Decisions regarding data sharing will be made after completion of the study and publication of the primary results, in accordance with institutional policies and applicable regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Department of Nephrology', 'investigatorFullName': 'Olynka Vega', 'investigatorAffiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}}}}