Nctid:
NCT06224790
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003929", "term"=>"Diabetic Neuropathies"}, {"id"=>"D007674", "term"=>"Kidney Diseases"}, {"id"=>"D003928", "term"=>"Diabetic Nephropathies"}, {"id"=>"D003924", "term"=>"Diabetes Mellitus, Type 2"}], "ancestors"=>[{"id"=>"D003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}, {"id"=>"D004700", "term"=>"Endocrine System 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"=>"D010523", "term"=>"Peripheral Nervous System Diseases"}, {"id"=>"D009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D048909", "term"=>"Diabetes Complications"}], "browseLeaves"=>[{"id"=>"M7124", "name"=>"Diabetic Neuropathies", "asFound"=>"Diabetic Neuropathy", "relevance"=>"HIGH"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "relevance"=>"LOW"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "asFound"=>"Nephropathy", "relevance"=>"HIGH"}, {"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "asFound"=>"Type 2 Diabetes", "relevance"=>"HIGH"}, {"id"=>"M7123", "name"=>"Diabetic Nephropathies", "asFound"=>"Diabetic Nephropathy", "relevance"=>"HIGH"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M13432", "name"=>"Peripheral Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"M26004", "name"=>"Diabetes Complications", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"C093844", "term"=>"Pirfenidone"}], "ancestors"=>[{"id"=>"D000700", "term"=>"Analgesics"}, {"id"=>"D018689", "term"=>"Sensory System Agents"}, {"id"=>"D018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000894", "term"=>"Anti-Inflammatory Agents, Non-Steroidal"}, {"id"=>"D018712", "term"=>"Analgesics, Non-Narcotic"}, {"id"=>"D000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M194811", "name"=>"Pirfenidone", "asFound"=>"Carbonate", "relevance"=>"HIGH"}, {"id"=>"M4032", "name"=>"Analgesics", "relevance"=>"LOW"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4218", "name"=>"Anti-Inflammatory Agents, Non-Steroidal", "relevance"=>"LOW"}, {"id"=>"M20786", "name"=>"Analgesics, Non-Narcotic", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>60}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-10", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-03-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-16", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-09", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"15% improvement in eGFR", "timeFrame"=>"6 months", "description"=>"15% improvement in eGFR"}], "secondaryOutcomes"=>[{"measure"=>"Safety - Adverse Effects of Drugs", "timeFrame"=>"6 months", "description"=>"Adverse Effects of the drugs"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Type 2 Diabetes Mellitus", "Diabetic Nephropathy", "Perfenidone"], "conditions"=>["Diabetic Nephropathies", "Type 2 Diabetes"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine the effectiveness \\& safety of pirfenidone in type 2 diabetic patients with diabetic nephropathy"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"30 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Diabetic Nephropathy Stage 3 (eGFR 30-59 mL/min/1.73m2) Type 2 Diabetes HbA1c \\<7.5% Patient taking ACEi/ARB for at least 3 months BP \\<140/90\n\nExclusion Criteria:\n\n* History of photosensitivity rash History of decompensated liver or cardiac disease History of urinary tract infection Pregnancy or lactation History of nephrotoxic drugs or hakeem medication Polycystic kidney disease History of autoimmune disease History of hypersensitivity to study drugs"}, "identificationModule"=>{"nctId"=>"NCT06224790", "acronym"=>"PenDaNt", "briefTitle"=>"Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy", "organization"=>{"class"=>"OTHER", "fullName"=>"King Edward Medical University"}, "officialTitle"=>"Effectiveness & Safety of Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy: A Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"483/RC/KEMU/2022"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Group A (Pirfenidone)", "description"=>"Capsule Pirfenidone 200mg, 2 X 8hrly for 3 months", "interventionNames"=>["Drug: Pirfenidone"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Group B", "description"=>"Placebo capsules - 2 X 8hrly for 3 months", "interventionNames"=>["Other: Placebo"]}], "interventions"=>[{"name"=>"Pirfenidone", "type"=>"DRUG", "description"=>"Capsule Pirfenidone 1200mg/ day in divided doses for 3 months", "armGroupLabels"=>["Group A (Pirfenidone)"]}, {"name"=>"Placebo", "type"=>"OTHER", "description"=>"2 Capsules 3 times a day for 3 months", "armGroupLabels"=>["Group B"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"54000", "city"=>"Lahore", "state"=>"Punjab", "status"=>"RECRUITING", "country"=>"Pakistan", "contacts"=>[{"name"=>"AP Endocrinology", "role"=>"CONTACT", "email"=>"sidrah.lodhi@gmail.com", "phone"=>"+923004683473"}], "facility"=>"King Edward Medical University", "geoPoint"=>{"lat"=>31.558, "lon"=>74.35071}}], "centralContacts"=>[{"name"=>"AP Endocrinology", "role"=>"CONTACT", "email"=>"sidrah.lodhi@gmail.com", "phone"=>"03004683473"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Sidrah Lodhi", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor of Medicine", "investigatorFullName"=>"Sidrah Lodhi", "investigatorAffiliation"=>"King Edward Medical University"}}}}
