Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00870493
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2009-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aliskiren for Immunoglobulin A (IgA) Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}], 'ancestors': [{'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': 'C446481', 'term': 'aliskiren'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-03', 'studyFirstSubmitDate': '2009-03-26', 'studyFirstSubmitQcDate': '2009-03-26', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the degree of proteinuria', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'rate of decline of estimated GFR', 'timeFrame': '16 weeks'}, {'measure': 'change in serum and urinary inflammatory markers', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['proteinuria', 'renal failure', 'glomerulonephritis'], 'conditions': ['IgA Nephropathy']}, 'referencesModule': {'references': [{'pmid': '38299639', 'type': 'DERIVED', 'citation': 'Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.'}, {'pmid': '23675422', 'type': 'DERIVED', 'citation': 'Szeto CC, Kwan BC, Chow KM, Leung CB, Li PK. The safety and short-term efficacy of aliskiren in the treatment of immunoglobulin a nephropathy--a randomized cross-over study. PLoS One. 2013 May 10;8(5):e62736. doi: 10.1371/journal.pone.0062736. Print 2013.'}]}, 'descriptionModule': {'briefSummary': 'Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. Current treatment with angiotensin converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) is not entirely effective. Aliskiren, a direct renin inhibitor, acts on the rate limiting step of the renin-angiotensin axis. In addition to lowering the blood pressure, recent study in diabetic nephropathy suggests an independent anti-proteinuric effect. The investigators plan to conduct a randomized placebo-control cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of IgA nephropathy. The investigators plan to recruit 57 patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy. They will be randomized to aliskiren for 16 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. This study will explore the potential anti-proteinuric effect of aliskiren in the treatment of IgA nephropathy, which has no specific treatment at present.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged 18-65 years\n* requires anti-hypertensive therapy\n* renal biopsy within the past 3 years and confirmed the diagnosis of IgA nephropathy\n* proteinuria \\> 1 g/day (or proteinuria \\> 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or ARB treatment for at least 3 months\n* estimated glomerular filtration rate \\> 30 ml/min/1.73m2\n* willingness to give written consent and comply with the study protocol\n\nExclusion Criteria:\n\n* Patients who are diabetic, and patients with systemic diseases that may cause IgA nephropathy or another nephropathy.\n* Pregnancy, lactating or childbearing potential without effective method of birth control\n* Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication\n* History of malignancy, including leukemia and lymphoma within the past 2 years\n* Systemic infection requiring therapy at study entry\n* Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension\n* History of drug or alcohol abuse within past 2 years\n* Participation in any previous trial on aliskiren or other renin inhibitor\n* Previous treatment with fish oil, steroid, cytotoxic agents, or aldosterone antagonist\n* History of treatment with other drugs that may affect proteinuria within past 2 years\n* Patients receiving treatment of corticosteroid\n* On other investigational drugs within last 30 days\n* History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study\n* History of non-compliance\n* Known history of sensitivity or allergy to aliskiren or other renin inhibitor"}, 'identificationModule': {'nctId': 'NCT00870493', 'briefTitle': 'Aliskiren for Immunoglobulin A (IgA) Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'The Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study', 'orgStudyIdInfo': {'id': 'AIgA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'each subject will receive oral aliskiren 300 mg/day for 16 weeks, followed by a washout period of 4 weeks, then crossed over to placebo for another 16 weeks', 'interventionNames': ['Drug: Aliskiren', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'description': 'each subject will receive placebo for 16 weeks, followed by a washout period of 4 weeks, then crossed over to oral aliskiren 300 mg/day for another 16 weeks', 'interventionNames': ['Drug: Aliskiren', 'Drug: Placebo']}], 'interventions': [{'name': 'Aliskiren', 'type': 'DRUG', 'description': 'Aliskiren 300 mg daily oral', 'armGroupLabels': ['I', 'II']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'starch tablet, 300 mg/day', 'armGroupLabels': ['I', 'II']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Cheuk-Chun SZETO', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}