Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-22 @ 8:41 PM
Study NCT ID:
NCT07151456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009402', 'term': 'Nephrosis, Lipoid'}], 'ancestors': [{'id': 'D009401', 'term': 'Nephrosis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse', 'timeFrame': 'through study completion, an average of 2 years', 'description': 'Relapse of proteinuria is defined by Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria.'}], 'secondaryOutcomes': [{'measure': 'Relapse rate', 'timeFrame': '12 months，24 months', 'description': 'the proportion of adults who develop relapsing'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Nephrotic Syndrome']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Evans JHC, Long E. A national audit of nephrotic syndrome: The initial course of prednisolone and outcome. Abstract. Ped Nephrol 1998;12(7):C154'}, {'pmid': '15106158', 'type': 'BACKGROUND', 'citation': 'Hodson EM, Knight JF, Willis NS, Craig JC. Corticosteroid therapy for nephrotic syndrome in children. Cochrane Database Syst Rev. 2004;(2):CD001533. doi: 10.1002/14651858.CD001533.pub2.'}, {'pmid': '7488812', 'type': 'BACKGROUND', 'citation': 'Ksiazek J, Wyszynska T. Short versus long initial prednisone treatment in steroid-sensitive nephrotic syndrome in children. Acta Paediatr. 1995 Aug;84(8):889-93. doi: 10.1111/j.1651-2227.1995.tb13787.x.'}, {'pmid': '10369190', 'type': 'BACKGROUND', 'citation': 'Bargman JM. Management of minimal lesion glomerulonephritis: evidence-based recommendations. Kidney Int Suppl. 1999 Jun;70:S3-16. doi: 10.1046/j.1523-1755.1999.07002.x.'}, {'pmid': '4191931', 'type': 'BACKGROUND', 'citation': 'Abramowicz M, Barnett HL, Edelmann CM Jr, Greifer I, Kobayashi O, Arneil GC, Barron BA, Gordillo-P G, Hallman N, Tiddens HA. Controlled trial of azathioprine in children with nephrotic syndrome. A report for the international study of kidney disease in children. Lancet. 1970 May 9;1(7654):959-61. doi: 10.1016/s0140-6736(70)91093-7. No abstract available.'}, {'pmid': '1860269', 'type': 'BACKGROUND', 'citation': 'Brodehl J. Conventional therapy for idiopathic nephrotic syndrome in children. Clin Nephrol. 1991;35 Suppl 1:S8-15.'}, {'pmid': '8129444', 'type': 'BACKGROUND', 'citation': 'Consensus statement on management and audit potential for steroid responsive nephrotic syndrome. Report of a Workshop by the British Association for Paediatric Nephrology and Research Unit, Royal College of Physicians. Arch Dis Child. 1994 Feb;70(2):151-7. doi: 10.1136/adc.70.2.151. No abstract available.'}, {'pmid': '2857421', 'type': 'BACKGROUND', 'citation': 'Trompeter RS, Lloyd BW, Hicks J, White RH, Cameron JS. Long-term outcome for children with minimal-change nephrotic syndrome. Lancet. 1985 Feb 16;1(8425):368-70. doi: 10.1016/s0140-6736(85)91387-x.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Urine protein: creatinine ratio ≥3000mg/g (300mg/mmol)\n* Serum/plasma albumin level \\< 30g/L\n* Age ≥ 16 years at the time of diagnosis\n* No prior therapy with steroids, immunosuppressive or cytotoxic agents for any form of renal disease (other than the 28 days of prednisolone therapy given initially as routine clinical practice)\n* No evidence of underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome\n* Informed consent\n* SSNS defined as Complete remission within 4 weeks of prednisone or prednisolone at standard dose\n\nExclusion Criteria:\n\n* Secondary nephrotic syndrome\n* Contradictions for glucocorticoids\n* SRNS: Lack of complete remission within 4 weeks of therapy with daily prednisone or prednisolone at standard dose\n* anti-PLA2R positive\n* Adults with histological changes other than minimal lesion or focal segmental glomerular sclerosis (FSGS) glomerulonephritis where renal biopsy has been undertaken\n* Adults with a prior history of poor compliance with medical therapy Known allergy to glucocorticoid therapy\n* Other situations where the researcher deems it inappropriate to participate in the study'}, 'identificationModule': {'nctId': 'NCT07151456', 'briefTitle': 'Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Short-term vs Conventional Glucocorticoid Therapy for the Treatment of the Initial Episode of Adult Patient With Steroid-sensitive Idiopathic Nephrotic Syndrome', 'orgStudyIdInfo': {'id': 'KY2025-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional course prednisolone arm', 'interventionNames': ['Drug: Conventional 24-week glucocorticoid regimen']}, {'type': 'EXPERIMENTAL', 'label': 'short-term course prednisolone arm', 'interventionNames': ['Drug: short-term course (12 week) glucocorticoid regimen']}], 'interventions': [{'name': 'Conventional 24-week glucocorticoid regimen', 'type': 'DRUG', 'description': 'Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5 - 6: Prednisolone 0.8mg/kg/day (max 60mg); Weeks 7 - 8: Prednisolone 0.6mg/kg/day (max 50mg); Weeks 9 - 10: Prednisolone 0.5mg/kg/day (max 40mg); Weeks 11 - 12: Prednisolone 0.4mg/kg/day (max 30mg); Weeks 13 - 16: Prednisolone 0.3mg/kg/day (max 25mg); Weeks 17 - 20: Prednisolone 0.2mg/kg/day (max 15 Weeks 21 - 24: Prednisolone 0.1mg/kg/day (max 10mg).', 'armGroupLabels': ['conventional course prednisolone arm']}, {'name': 'short-term course (12 week) glucocorticoid regimen', 'type': 'DRUG', 'description': 'Weeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5-8: Prednisolone 1mg/kg/day (max 80mg) on alternate days; 9-12: Prednisolone 0.5mg/kg/day (max 40mg) on alternate days', 'armGroupLabels': ['short-term course prednisolone arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Tianxin Chen, PhD', 'role': 'CONTACT', 'email': 'ctxzjf@163.com', 'phone': '+86057755578056'}], 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tianxin Chen', 'investigatorAffiliation': 'First Affiliated Hospital of Wenzhou Medical University'}}}}