Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-24 @ 12:56 PM
Study NCT ID:
NCT02511418
Status:
COMPLETED
Last Update Posted:
2023-03-16
First Post:
2015-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2015-07-24', 'studyFirstSubmitQcDate': '2015-07-27', 'lastUpdatePostDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of short term HMG-CoA reductase treatment', 'timeFrame': '4 weeks', 'description': "Differences between mean values for RPF, GFR and FF at baseline versus mean values obtained for these same parameters after 4 weeks of treatment will be analyzed using two-tailed Student's paired t-test. A similar analysis will be performed regarding patient's profiles for creatinine clearance, serum creatinine, urinary protein excretion and serum lipids. All results will be expressed as mean ± standard deviations. Differences will be considered significant at P \\<0.05."}]}, 'conditionsModule': {'conditions': ['Hyperlipidemia', 'Hypertension', 'Chronic Renal Failure']}, 'referencesModule': {'references': [{'pmid': '26614268', 'type': 'DERIVED', 'citation': 'Zand L, Torres VE, Larson TS, King BF, Sethi S, Bergstralh EJ, Angioi A, Fervenza FC. Renal hemodynamic effects of the HMG-CoA reductase inhibitors in autosomal dominant polycystic kidney disease. Nephrol Dial Transplant. 2016 Aug;31(8):1290-5. doi: 10.1093/ndt/gfv394. Epub 2015 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'This study was done to determine whether Simvastatin (a medication commonly used to treat patients with high cholesterol levels in the blood increases blood flow to the kidneys and improves renal function in normal volunteers and patients with impaired renal function secondary to polycystic kidney diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients with chronic renal failure:\n\n1. Age 18 or older\n2. Chronic renal failure secondary to Autosomal Dominant Polycystic Kidney Disease\n3. Serum creatinine ≥ 1.4 but ≤ 2.0 mg/dl\n4. Creatinine or iothalamate clearance between 35-70 ml/min per 1.73m2\n5. Stable renal function for the three preceding months\n6. Blood pressure needs to be adequately controlled (\\< 140/90 mm Hg), with or without the use of antihypertensive agents. However, ACE inhibitors or AT1 receptor blockers must not be initiated, or have their dose increased during the study period.\n\nPatients with normal renal function:\n\n1. Age 18 or older\n2. Normal renal function and diagnosed with Autosomal Dominant Polycystic Kidney Disease\n3. Serum creatinine ≤ 1.4\n4. Creatinine or iothalamate clearance ≥70 ml/min per 1.73m2\n5. Renal function has to be stable for the three preceding months\n6. Blood pressure needs to be adequately controlled (\\< 140/90 mm Hg), with or without the use of antihypertensive agents. However, ACE inhibitors or AT1 receptor blockers must not be initiated, or have their dose increased during the study period.\n\nExclusion criteria include:\n\n1. Patients using corticosteroids, cytotoxic drugs (alkylating agents, chlorambucil, cyclophosphamide), CellCept, or cyclosporin A therapy\n2. Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab)\n3. Serum transaminase levels (AST, ALT) 2 times the upper limit of normal\n4. Clinically significant medical conditions\n5. Pregnant patients, patients who are breast-feeding, or women intending to conceive during the course of the study\n6. Presence or suspicion of active infection, recent serious infection or chronic/recurrent viral or bacterial infection\n7. Presence of concomitant renal artery stenosis.'}, 'identificationModule': {'nctId': 'NCT02511418', 'briefTitle': 'Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure', 'orgStudyIdInfo': {'id': '475-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Simvastatin', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D', 'investigatorFullName': 'Fernando Fervenza', 'investigatorAffiliation': 'Mayo Clinic'}}}}