Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT06948292
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2025-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of QRX-3 in Chronic Kidney Disease Patients in Outpatients Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'C563161', 'term': 'Hypertensive Nephropathy'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'QRX-3 added to intervention group in addition to standard therapy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-31', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'daily change in glomerular filtration rate by creatinine in mls/min', 'timeFrame': '12 months', 'description': 'mean change in glomerular filtration rate by creatinine in mls/min in one year compare to baseline at screening'}], 'secondaryOutcomes': [{'measure': 'change in proteinuria by mg/g', 'timeFrame': '12 months', 'description': 'change in mean proteinuria measured by random urine protein/creatinine ratio at 12 months compare to control will be compared in both groups'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD', 'estimated GFR (eGFR)', 'proteinuria', 'random urine protein creatinine ratio', 'creatinine change'], 'conditions': ['Chronic Kidney Disease Stages 3-5', 'Diabetic Kidney Disease', 'Hypertensive Kidney Disease']}, 'descriptionModule': {'briefSummary': 'QRX-3, a new drug that stabilized the kidney renal tubular cell and increase the activity of NAD ( nicotinamide adenine dineuclotide )within the kidney cells; leading to decrease oxidative changes intracellularly, repair of renal tubular injury and restoration of optimized renal function above baseline , will be studied in patients with progressive chronic kidney disease over 12 months . The result of the change in renal function expressed as creatinine GFR (Glomerular filtration decline) over the treatment duration will be compared in the treatment group will be compared to control group without the medication during that same period .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Chronic kidney disease stage 3-5\n* Estimated Glomerular function by MDRD of less than 60mls/min\n* Patients with declining renal function ( as measured by eGFR by MDRD )\n* Rate of decline of eGFR over the last one year of less than 20%\n* Negative Serology markers for CKD etiology\n* Provider perceived adherence to study follow- up\n\nExclusion Criteria:\n\n* Rapid rate of decline in kidney function of \\> 10 % over 3 months\n* Symptomatic renal failure\n* Presence of any suspected Acute renal failure superimposed\n* Presence of cast , hematuria, or abnormal urinalysis outside of simple UTI\n* No known reversible cause of renal decline'}, 'identificationModule': {'nctId': 'NCT06948292', 'acronym': 'QRX-3 in CKD', 'briefTitle': 'Role of QRX-3 in Chronic Kidney Disease Patients in Outpatients Clinics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neukidney Inc.'}, 'officialTitle': 'Role of QRX-3 a Novel NAD Modulator in Ambulatory Chronic Kidney Patients', 'orgStudyIdInfo': {'id': '0002B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'control group - continued on standard therapy for CKD'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'QRX-3 drug given in addition to standard therapy for CKD', 'interventionNames': ['Drug: QRX-3']}], 'interventions': [{'name': 'QRX-3', 'type': 'DRUG', 'description': 'phase 2B CKD study', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77504', 'city': 'Pasedena', 'state': 'Texas', 'country': 'United States', 'facility': 'Neukidney Inc'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '4/21/2025 to 10/21/2025', 'ipdSharing': 'YES', 'description': 'if requested , deidentifiable data can be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ebima Clifford Okundaye', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ebima Clifford Okundaye', 'investigatorAffiliation': 'Neukidney Inc.'}}}}