Clinical Trial Details
| Trial ID: | L0039 |
| Source ID: | NCT03119662 |
| Associated Drug: | Visipaque |
| Title: | A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT03119662/results |
| Conditions: | Chronic Kidney Diseases |
| Interventions: | DRUG: Visipaque|DRUG: Placebos |
| Outcome Measures: | Primary: Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria, AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of \>=0.3 mg/dL (\>=26.4 μmol/L) or increase to \>=150% to 200% (\>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to \>200% to 300% (\>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to \>300% (\>3.0-fold) from baseline or SCr \>=4.0 mg/dL (\>=354 μmol/L) with an acute increase of \>=0.5 mg/dL (\>=44 μmol/L) within 48 hours., 48 hours post-baseline (Follow-up 1) | Secondary: Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria, AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of \>=0.3 mg/dL (\>=26.4 μmol/L) or increase to \>=150% to 200% (\>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to \>200% to 300% (\>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to \>300% (\>3.0-fold) from baseline or SCr \>=4.0 mg/dL (\>=354 μmol/L) with an acute increase of \>=0.5 mg/dL (\>=44 μmol/L) within 48 hours., 48 hours post-baseline (Follow-up 1)|Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN), Standard definition of CIN: Increase in SCr of 0.5 mg/dL or more in the 24 to 72 hours after the CT scan., 48 hours post-baseline (Follow-up 1)|Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria, Waikar's definitions of AKI: Stage 1: 0.3 mg/dL increase in SCr over 24 hours or a 0.5 mg/dL increase in SCr over 48 hours. Stage 2: 0.5 mg/dL increase in SCr over 24 hours or a 1.0 mg/dL increase in SCr over 48 hours. Stage 3: 1.0 mg/dL increase in SCr over 24 hours or a 1.5 mg/dL increase in SCr over 48 hours., 48 hours post-baseline (Follow-up 1)|All Cause Mortality and Morbidity, Mortality (all cause death) and morbidity i.e. critical events., From Baseline to Month 6|Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale, Blinded independent assessment of image quality/diagnostic confidence using a 5-point scale. Image quality/diagnostic confidence for all imaging studies was rated on a 5-point scale from 1 (poor) to 5 (excellent)., Month 6 |
| Sponsor/Collaborators: | Sponsor: GE Healthcare | Collaborators: Syneos Health |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 4 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER |
| Start Date: | 2018-02-08 |
| Completion Date: | 2018-10-19 |
| Results First Posted: | 2019-12-17 |
| Last Update Posted: | 2019-12-17 |
| Locations: | University Hospital, Birmingham, Alabama, 35233, United States|: Aventiv Research Inc., Mesa, Arizona, 85210, United States|Central Arkansas Veteran's Healthcare System, Little Rock, Arkansas, 72205, United States|Alliance Research Centers, Laguna Hills, California, 92653, United States|Universal Axon Clinical Research, LLC, Doral, Florida, 33166, United States|Jacksonville Center for Clinical Research, Jacksonville, Florida, 32216, United States|University of South Florida - South Tampa Campus, Tampa, Florida, 33606, United States|University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States|Norton Hospital, Louisville, Kentucky, 40202, United States|Boston University Medical Center/Boston Medical Center, Boston, Massachusetts, 02118, United States|The Duluth Clinic, Ltd., Duluth, Minnesota, 55805, United States|Mount Sinai West, New York, New York, 10019, United States|University of North Carolina at Chapel Hill Clinical Translational Research Center, Chapel Hill, North Carolina, 27599, United States|Wake Forest Baptist Health, Winston-Salem, North Carolina, 27157, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|UT Southwestern Medical Center, Dallas, Texas, 75390, United States|University of Vermont Medical Center, Burlington, Vermont, 05401, United States|UZ Leuven, Leuven, 3000, Belgium|CRCHUM- CHUM Research Center, Montreal, H2X 0A9, Canada|St. Boniface General Hospital, Winnipeg, R2H 2A6, Canada|Oddzial Chirurgii Naczyniowej i Ogolnej, Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu, Bytom, 41-902, Poland|Klinika Kardiochirurgii i Chirurgii Naczyniowej, Uniwersyteckie Centrum Kliniczne, Gdansk, 80-952, Poland|Klinika Chirurgii Naczyniowej i Angiologii, Samodzielny Publiczny Szpital Kliniczny nr 1, Lublin, 20-081, Poland|Oddzial Chirurgii Ogolnej i Naczyn, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego, Poznan, 61-848, Poland|Hospital Clinic de Barcelona, Barcelona, 08036, Spain|Hospital Universitario Puerta del Mar, Cadiz, 11009, Spain|Hospital Universitario Son Espases, Palma, 07120, Spain|St. George's Healthcare NHS Trust, St. George's Hospital, London, SW17 0QT, United Kingdom|Royal Stoke University Hospital, Radiology Department, Stoke on Trent, ST4 6QG, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT03119662 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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