Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-30 @ 4:02 AM
Study NCT ID:
NCT00755859
Status:
COMPLETED
Last Update Posted:
2008-09-19
First Post:
2008-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Steroids and Azathioprine Versus Steroids Alone in IgAN"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013256', 'term': 'Steroids'}, {'id': 'D001379', 'term': 'Azathioprine'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'C407664', 'term': 'deltacortene'}, {'id': 'D000255', 'term': 'Adenosine Triphosphate'}], 'ancestors': [{'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-18', 'studyFirstSubmitDate': '2008-09-18', 'studyFirstSubmitQcDate': '2008-09-18', 'lastUpdatePostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression of renal disease, estimated by the time to 50% increase in plasma creatinine from baseline.', 'timeFrame': 'Every month for the first six months, then six months'}], 'secondaryOutcomes': [{'measure': 'evolution of proteinuria over time', 'timeFrame': 'every months for the first six months and then every six months'}, {'measure': 'safety', 'timeFrame': 'every months for the first six months and then every six months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IgA nephropathy', 'steroids', 'azathioprine', 'chronic kidney disease progression', 'proteinuria'], 'conditions': ['IGA Nephropathy']}, 'referencesModule': {'references': [{'pmid': '10630693', 'type': 'BACKGROUND', 'citation': 'Locatelli F, Pozzi C, Del Vecchio L, Andrulli S, Pani A, Fogazzi G, Altieri P, Ponticelli C. Combined treatment with steroids and azathioprine in IgA nephropathy: design of a prospective randomised multicentre trial. J Nephrol. 1999 Sep-Oct;12(5):308-11.'}]}, 'descriptionModule': {'briefSummary': 'In a previous trial the investigators found that the effect of steroids in IgA nephropathy diminish over time. The difference in renal survival is striking up till the third year, but then remains constant. A six-month course of steroid therapy may be not enough to ensure a stable remission. The investigators hypothesized that a more aggressive treatment may obtain long-term better results. The investigators conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.', 'detailedDescription': 'In 1999, we published a multicenter, randomized, controlled trial, which compared a 6-month steroid course with supportive therapy in 86 patients with IgAN. After 5 years of follow-up, the risk of a 50% increase in plasma creatinine from baseline was significantly lower in the treated patients; proteinuria also decreased. However, the effect of steroids seemed to diminish over time. The difference in renal survival was particularly striking up till the third year, but then remained constant. We hypothesised that a six-month course of steroid therapy is not enough to ensure a stable remission, and a more aggressive treatment may be required to obtain long-term better results. At this regard, some studies of combined treatment with corticosteroids and azathioprine found that treatment was effective in preserving renal function and in reducing proteinuria. However, these studies did not clarify whether azathioprine added further benefit to steroids in the long term. We conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy proven IgA nephropathy\n* creatinine ≤ 2.0 mg/dl for at least three months\n* proteinuria ≥ 1.0 g/day for at least three months\n\nExclusion Criteria:\n\n* treatment with steroids or cytotoxic drugs during the previous three years\n* contraindications to steroids or azathioprine\n* Henoch-Schöenlein purpura\n* diabetes mellitus\n* severe hypertension (diastolic blood pressure \\> 120 mmHg)\n* lupus erythematosus systemicus\n* malignancies\n* active peptic-ulcer disease\n* pregnancy\n* viral hepatitis or other infections'}, 'identificationModule': {'nctId': 'NCT00755859', 'briefTitle': '"Steroids and Azathioprine Versus Steroids Alone in IgAN"', 'organization': {'class': 'OTHER', 'fullName': 'A. Manzoni Hospital'}, 'officialTitle': 'Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'IgANSTAZA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Six month steroid course plus azathioprine', 'interventionNames': ['Drug: steroids plus azathioprine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'six month steroid course', 'interventionNames': ['Drug: steroids']}], 'interventions': [{'name': 'steroids plus azathioprine', 'type': 'DRUG', 'otherNames': ['solumedrol', 'deltacortene', 'azatioprina'], 'description': 'methylprednisolone 1 g i.v. for three consecutive days at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day plus azathioprine 1.5 mg/kg/day for six months', 'armGroupLabels': ['1']}, {'name': 'steroids', 'type': 'DRUG', 'otherNames': ['solumedrol', 'deltacortene'], 'description': 'methylprednisolone 1 g i.v. for three consecutive days at the beginning of months 1, 3 and 5, followed by oral prednisone 0.5 mg/kg every other day for six months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seriate', 'state': 'BG', 'country': 'Italy', 'facility': 'Hospital "Bolognini"', 'geoPoint': {'lat': 45.68532, 'lon': 9.72487}}, {'city': 'Brescia', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Hospital "Spedali Civili"', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Montichiari', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Hospital of Montichiari', 'geoPoint': {'lat': 45.41317, 'lon': 10.39799}}, {'city': 'Cagliari', 'state': 'Cagliari', 'country': 'Italy', 'facility': '"G. Brotzu" Hospital', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Catania', 'state': 'Catania', 'country': 'Italy', 'facility': 'Hospital "Cannizzaro"', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '22100', 'city': 'Como', 'state': 'CO', 'country': 'Italy', 'facility': 'Hospital "S.Anna"', 'geoPoint': {'lat': 45.80819, 'lon': 9.0832}}, {'city': 'Cremona', 'state': 'CR', 'country': 'Italy', 'facility': 'Hospital "Istituti Ospitalieri"', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'city': 'Acireale', 'state': 'CT', 'country': 'Italy', 'facility': 'Hospital "S.Marta e S.Venera",', 'geoPoint': {'lat': 37.60886, 'lon': 15.16577}}, {'city': 'Taormina', 'state': 'CT', 'country': 'Italy', 'facility': 'Hospital "S.Vincenzo"', 'geoPoint': {'lat': 37.85358, 'lon': 15.28851}}, {'city': 'Florence', 'state': 'Firenze', 'country': 'Italy', 'facility': 'Hospital "Careggi"', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Foggia', 'state': 'Foggia', 'country': 'Italy', 'facility': 'Hospital of University', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '23900', 'city': 'Lecco', 'state': 'LC', 'country': 'Italy', 'facility': 'Department of Nephrology and Dialysis, A. Manzoni Hospital', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'city': 'Lodi', 'state': 'LO', 'country': 'Italy', 'facility': 'Hospital "Maggiore"', 'geoPoint': {'lat': 45.30989, 'lon': 9.50085}}, {'city': 'Mantova', 'state': 'Mantova', 'country': 'Italy', 'facility': 'Hospital "C. Poma"', 'geoPoint': {'lat': 45.16031, 'lon': 10.79784}}, {'city': 'Cernusco sul Naviglio', 'state': 'MI', 'country': 'Italy', 'facility': 'Hospital "Uboldo"', 'geoPoint': {'lat': 45.52526, 'lon': 9.33297}}, {'city': 'Desio', 'state': 'MI', 'country': 'Italy', 'facility': 'Hospital of Desio', 'geoPoint': {'lat': 45.61831, 'lon': 9.20249}}, {'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Hospital "Maggiore" IRCCS', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Nuoro', 'state': 'Nuoro', 'country': 'Italy', 'facility': 'Hospital "S. Francesco"', 'geoPoint': {'lat': 40.31991, 'lon': 9.32568}}, {'city': 'Ozieri', 'state': 'Nuoro', 'country': 'Italy', 'facility': 'Hospital "A.Segni"', 'geoPoint': {'lat': 40.5863, 'lon': 9.0034}}, {'city': 'Palermo', 'state': 'Palermo', 'country': 'Italy', 'facility': 'Hospital "V. Cervello"', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Parma', 'state': 'Parma', 'country': 'Italy', 'facility': 'University Hospital', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Pavia', 'state': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione Maugeri" IRCCS', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Reggio Calabria', 'state': 'Reggio Calabria', 'country': 'Italy', 'facility': 'CNR-IBIM', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Reggio Emilia', 'state': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Hospital "S. Maria Nuova"', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Sondrio', 'state': 'Sondrio', 'country': 'Italy', 'facility': 'Hospital of Sondrio', 'geoPoint': {'lat': 46.16852, 'lon': 9.87134}}, {'city': 'Torino', 'state': 'Torino', 'country': 'Italy', 'facility': 'CMID', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Viterbo', 'state': 'Viterbo', 'country': 'Italy', 'facility': 'Hospital "Belcolle"', 'geoPoint': {'lat': 42.41937, 'lon': 12.1056}}, {'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Claudio Pozzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A Manzoni Hospital, Lecco, Italy'}, {'name': 'Francesco Locatelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'A Manzoni Hospital, Lecco, Italy'}, {'name': 'Simeone Andrulli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'A Manzoni Hospital, Lecco, Italy'}, {'name': 'Antonello Pani, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital "G. Brotzu", Cagliari, Italy'}, {'name': 'Paolo Altieri, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital "G. Brotzu", Cagliari, Italy'}, {'name': 'Gian B Fogazzi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital "Maggiore" IRCCS, Milan, Italy'}, {'name': 'Claudio Ponticelli, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital "Maggiore" IRCCS, Milan, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A. Manzoni Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Claudio Pozzi', 'oldOrganization': 'A. Manzoni Hospital, Lecco, Italy'}}}}