Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-13 @ 8:50 AM
Study NCT ID:
NCT02644928
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2015-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'In this study, blood and urine samples will be collected to determine the effect of weight loss in proteinuria and renal function.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2015-12-23', 'studyFirstSubmitQcDate': '2015-12-31', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of proteinuria/albuminuria in patients with obesity and nephropathy of any etiology treated with bariatric surgery', 'timeFrame': '24 months', 'description': 'Reduction (measured as a percentage) of proteinuria/albuminuria in patients with obesity after bariatric surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'Bariatric Surgery Candidate', 'Caloric restriction'], 'conditions': ['Chronic Kidney Disease', 'Bariatric Surgery Candidate']}, 'descriptionModule': {'briefSummary': 'This study is designed as a prospective, single-center, longitudinal and analytical study on the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).', 'detailedDescription': 'It is expected to enroll 22 obese subjects with chronic kidney disease (decrease in glomerular filtration and/or albuminuria/proteinuria). After the inclusion in the study patients will remain for six months with a reduced calorie diet until the day of bariatric surgery. Time monitoring of the patient after surgery is 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Obese subjects with renal pathology (decrease in glomerular filtration and/or albuminuria/proteinuria) who are candidates to bariatric surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years (male or female).\n* BMI \\>35 kg/m2 who meet the following criteria:\n\n 1. GFR 30-60 ml/min and proteinuria\\>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.\n 2. GFR \\>60 ml/min and proteinuria \\>(3.5) 2.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.\n* Patients with BMI\\> 40 kg/m2 with a GFR\\> 30 ml/min and proteinuria \\>(1) 0.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.\n* Patients who are able to understand the purpose and risks of the study, which has been fully informed and have finally given the written informed consent according to the ICH-GCP. Patients who can not read or write but who properly understand the verbal information provided by the investigator (or sub-investigator) the consent will be granted orally before their inclusion and an independent witness will signing the informed consent document.\n\nExclusion Criteria:\n\n* Subjects who are participating or have participated in another clinical trial and/or who are taking or have taken an experimental drug (not registered) in the last 28 days.\n* Patients with chronic renal replacement therapy (hemodialysis and/or peritoneal dialysis) and/or renal transplantation.\n* Patients with poorly controlled blood pressure (SBP\\> 170 mmHg or DBP\\> 110 mmHg).\n* Patients with a history of cardiovascular events (stroke, ischemic heart disease) in the past six months.\n* Patients treated with steroids or other immunosuppressants.\n* Patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug use.\n* Patients who are pregnant or lactating.\n* Patients who do not sign the informed consent.\n* A slight chance of compliance with visits scheduled in the protocol.'}, 'identificationModule': {'nctId': 'NCT02644928', 'briefTitle': 'Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'Effects of Weight Loss on Renal Function in Obese Patients With Chronic Kidney Disease Undergoing Bariatric Surgery', 'orgStudyIdInfo': {'id': 'HDOC-BAROBE-2015-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Enrique Morales Ruiz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario 12 de Octubre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enrique Morales Ruiz, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario 12 de Octubre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Enrique Morales Ruiz, MD', 'investigatorAffiliation': 'Hospital Universitario 12 de Octubre'}}}}