Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-01-03 @ 7:23 PM
Study NCT ID:
NCT00657059
Status:
COMPLETED
Last Update Posted:
2019-12-03
First Post:
2008-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077405', 'term': 'Irbesartan'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C036266', 'term': 'prednylidene'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013141', 'term': 'Spiro Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-01', 'studyFirstSubmitDate': '2008-04-08', 'studyFirstSubmitQcDate': '2008-04-11', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission of proteinuria (complete or partial)', 'timeFrame': 'up to 4.3 years'}], 'secondaryOutcomes': [{'measure': 'Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation)', 'timeFrame': "every 6 month for 4.3 years（including 3 months ARB leading-in phase， 1 years' treatment phase and 3 years' follow-up）"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IgA nephropathy', 'mycophenolate mofetil'], 'conditions': ['IgA Nephropathy']}, 'referencesModule': {'references': [{'pmid': '38864363', 'type': 'DERIVED', 'citation': 'Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.'}]}, 'descriptionModule': {'briefSummary': 'A multi-center, randomized, controlled clinical trial to evaluate the short-term and long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and preserving renal function in patients with IgAN who have pre-treated (and continue to be treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.', 'detailedDescription': 'There are four phases of study for each subject. Phase 1 the screening phase. During this phase each potential subject will be evaluated to determine if he/she is eligible for the study.\n\nPhase 2 the ARB lead-in phase will last for three months. Phase 3 the intervention phase. Each subject will be randomly received 12 months treatment with the study drugs (MMF, prednisone or MMF plus prednisone) Phase 4 following-up phase. All the patients will be followed by 3 years after study drug stopped.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willingness to sign an informed consent\n* Age:14\\~60 years, regardless of gender\n* Clinical evaluation and renal biopsy diagnostic for IgAN, excluded secondary IgAN. Renal histological criteria should be defined by Lee's glomerular grading system.\n* 1 g/day \\<= proteinuria \\< 3.5 g/day, or UPr/Cr ratio ≥ 0.6 (male) or ≥ 0.8 (female) when taking ARB\n* eGFR ≥ 40 mL/min/1.73 m2\n\nExclusion Criteria:\n\n* Inability or unwillingness to sign the informed consent\n* Inability or unwillingness to meet the scheme demands raised by the investigators\n* Rapidly progressive nephritic syndrome and acute renal failure, including rapidly progressive IgAN ( IgAN with rapid decline in renal function characterized histologically by necrotizing vasculitis and crescent formation≥30%) necessitating the use of other immunosuppressive agents.\n* Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis\n* est GFR \\< 40 mL/min/1.73m2\n* Malignant hypertension that is difficult to be controlled by oral drugs\n* Cirrhosis, chronic active liver disease.\n* History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease.)\n* Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C.\n* Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)\n* Malignant tumors (except fully cured basal cell carcinoma)\n* Absolute neutrophil count \\< 1500／mm3, absolute platelet count \\<75000／mm3 or hematocrit (Hct) \\<28% (anemic subjects may be reevaluated after the anemia has been treated.)\n* Known allergy, contraindication or intolerance to the MMF, corticosteroids or ACEI/ARB.\n* Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception\n* Current exposure to MMF or azathioprine. In case of current treatment with oral steroid or ACEI/ARB, entry is permitted after corticosteroids or ACEI/ARB are stopped for 2 weeks.\n* Current or recent (within 30 days) exposure to any other investigational drugs"}, 'identificationModule': {'nctId': 'NCT00657059', 'briefTitle': 'Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)', 'orgStudyIdInfo': {'id': 'SYSU-PRGIgAN-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pred group', 'description': 'Pred Group: Prednisone treatment Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month.', 'interventionNames': ['Drug: irbesartan', 'Drug: methylprednisolone (MP) or prednisone (pred)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MMF Group', 'description': 'MMF Group: MMF treatment Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt \\< 50kg) for the first 6-month of drug treatment phase, then 0.5 bid for the remaining 6-month.', 'interventionNames': ['Drug: irbesartan', 'Drug: mycophenolate mofetil (MMF)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pred plus MMF Group', 'description': 'Pred plus MMF Group: Prednisone plus MMF treatment. Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month.\n\nPatients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt \\< 50kg) for the first 6-month of drug treatment phase, then 0.5 bid for the remaining 6-month.', 'interventionNames': ['Drug: irbesartan', 'Drug: methylprednisolone (MP) or prednisone (pred)', 'Drug: mycophenolate mofetil (MMF)']}], 'interventions': [{'name': 'irbesartan', 'type': 'DRUG', 'otherNames': ['Aprovel, Sanofi-synthelabo'], 'description': 'In the ARB lead-in phase, each subject will be on a strict sodium-restricted diet ( \\< 5 g NaCl/day), and then given a stable dose (150mg \\~ 300mg/day) of irbesartan (Aprovel) for 3 months until reaching the target blood pressure (BP) level of ≤ 125/75 mmHg. Patients will continue ARB treatment in the drug treatment phase and at lease 3 years in the follow-up phase.', 'armGroupLabels': ['MMF Group', 'Pred group', 'Pred plus MMF Group']}, {'name': 'methylprednisolone (MP) or prednisone (pred)', 'type': 'DRUG', 'description': 'Patients will take oral Pred ( 0.5 mg/kg/d) on alternate days, and on the first, third and fifth months of the drug treatment phase, patients will be given intravenous pulse therapy with methylprednisolone ( 0.5 g/day) for 3 successive days. And after 6 months, Pred should be tapered to be stopped until the end of the 12-month course of treatment.', 'armGroupLabels': ['Pred group', 'Pred plus MMF Group']}, {'name': 'mycophenolate mofetil (MMF)', 'type': 'DRUG', 'otherNames': ['Cellcept,Roche'], 'description': 'Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt \\< 50kg) for the first 6-month of drug treatment phase, then to 0.5 bid (wt ≥ 50kg) for the remaining 6-month.', 'armGroupLabels': ['MMF Group', 'Pred plus MMF Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The 1st Affiliated Hospital, Sun Yet-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xueqing Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University'}, {'name': 'Yunha Liao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University,Guangxi'}, {'name': 'Jinli Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of nephrology, People's Hospital of Yunnan Province"}, {'name': 'Junzhou Fu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Nephrology,1st People's Hospital of Guangzhou"}, {'name': 'Anping Xu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 2nd Affiliated Hospital of Sun Yet-Sen University,Guangzhou'}, {'name': 'Zhangsuo liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 1st Affiliated hospital of Zhengzhou University, Henan'}, {'name': 'Tanqi lou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 3nd affiliated hospital of Sun yatsent university, Guangzhou'}, {'name': 'Li Hao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, 2nd Affiliated Hospital of Anhui Medical University, Anhui'}, {'name': 'Menghua Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, General Hospital of Ningxia Medical University, Ningxia'}, {'name': 'Qinkai Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, The First Affiliated Hospital of Nanchang University, Jiangxi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xue Qing Yu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}