Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-01-03 @ 12:18 AM
Study NCT ID:
NCT03259594
Status:
UNKNOWN
Last Update Posted:
2020-04-29
First Post:
2017-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Renal Functional Reserve Change In Patients With SRC Before and After Laparoscopic Deroofing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to two groups.One group participants are with endophytic simple renal cysts, and the other are with exophytic simple renal cysts.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-27', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-21', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in renal functional reserve after laparoscopic deroofing', 'timeFrame': '1 month after surgery.', 'description': '1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal functional reserve', 'Simple renal cysts', 'Laparoscopic deroofing'], 'conditions': ['Simple Renal Cyst']}, 'descriptionModule': {'briefSummary': 'Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing.', 'detailedDescription': 'Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions have been reported to occur more commonly among these patients with SRC and there are no clear guidelines for managing asymptomatic SRCs.Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).The investigators hypothesized that RFR may be improved in some patients with simple renal cysts after laparoscopic deroofing despite identical resting glomerular filtration rate (rGFR).The aim of this study is to examine whether there is improvement of RFR in patients with simple renal cysts after laparoscopic deroofing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18\n2. Estimated GFR \\>30 mL/min/1.73m2\n3. Subjects who signed informed consent forms\n\nExclusion Criteria:\n\n1. Allergy to iothalamate, shellfish or iodine\n2. Use of metformin or amiodarone\n3. Inability to maintain a stable regimen of medications which affect GFR for \\> one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)\n4. Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)\n5. Acute exacerbation of asthma or chronic obstructive pulmonary disease within 3 months requiring hospitalization or oral steroid therapy\n6. Inadequate intravenous access\n7. Severe anemia (Hct \\<21%)\n8. Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)\n9. History of contrast-induced nephropathy\n10. Hyperthyroidism\n11. Pheochromocytoma\n12. Sickle cell disease\n13. Urinary retention or incontinence\n14. Status post organ transplant\n15. Pregnancy or active breast feeding\n16. Cognitive impairment with inability to give consent\n17. Institutionalized status'}, 'identificationModule': {'nctId': 'NCT03259594', 'briefTitle': 'Measurement of Renal Functional Reserve Change In Patients With SRC Before and After Laparoscopic Deroofing', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Measurement of Renal Functional Reserve Change In Patients With Simple Renal Cysts Before and After Laparoscopic Deroofing', 'orgStudyIdInfo': {'id': 'otw-20170804-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'endophytic group', 'description': 'participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.', 'interventionNames': ['Procedure: Laparoscopic deroofing', 'Drug: 100 g of amino acids supplementation']}, {'type': 'SHAM_COMPARATOR', 'label': 'exophytic group', 'description': 'participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.', 'interventionNames': ['Procedure: Laparoscopic deroofing', 'Drug: 100 g of amino acids supplementation']}], 'interventions': [{'name': 'Laparoscopic deroofing', 'type': 'PROCEDURE', 'description': 'The classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity.', 'armGroupLabels': ['endophytic group', 'exophytic group']}, {'name': '100 g of amino acids supplementation', 'type': 'DRUG', 'otherNames': ['Compound Amino Acids Injection(18AA-Ⅶ)'], 'description': 'intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.', 'armGroupLabels': ['endophytic group', 'exophytic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenhua Shang, MD.', 'role': 'CONTACT'}], 'facility': 'Xuanwu Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhenhua Shang, MD.', 'role': 'CONTACT', 'email': 'shangzhenhua16@126.com', 'phone': '+8617801117318'}, {'name': 'Hao Yan, MD.', 'role': 'CONTACT', 'phone': '+8683198448'}], 'overallOfficials': [{'name': 'Tongwen Ou, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ou tongwen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Urology', 'investigatorFullName': 'ou tongwen', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}