Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
634 participants
OBSERVATIONAL
2013-02-28
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Drug Induced Renal Injury (DIRI)
This is a prospective observational cohort study of patients who have developed acute kidney injury Stage 2 or a glomerular disorder following exposure to specific drugs that have been associated with DIRI.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Exposure to a candidate drug for at least 24 hours (see above)
* Patients who have developed DIRI as defined by the primary criteria
* Written informed consent or assent and consent obtained
* If patient lacks capacity to consent then surrogate consent will be obtained
Exclusion Criteria
* Patients with a history of or have a bone marrow transplant
* Patients with Chronic Kidney Disease stage 5 (eGFR \< 15 mL/min/1.73m2)
* Patients on 3 or more causal drugs
* Patients with no history or time course on drug exposure
* Patient who, in the opinion of the Investigator, is not suitable to participate in the study.
* Unable to obtain written informed consent or assent
* Unable to obtain surrogate consent for patients who lack capacity
2 Years
ALL
No
Sponsors
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International Serious Adverse Event Consortium
UNKNOWN
Ravindra Mehta
OTHER
Responsible Party
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Ravindra Mehta
Professor of Clinical Medicine
Principal Investigators
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Ravindra Mehta, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
University of California, San Diego
San Diego, California, United States
Rady Children's Hospital
San Diego, California, United States
University of Colorado
Aurora, Colorado, United States
University of Michigan
Ann Arbor, Michigan, United States
St. Peter's Hospital
Albany, New York, United States
Jacobi Medical Center
New York, New York, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Universidad del Valle, Cochabamba
Cochabamba, , Bolivia
Hopital Sacre Coeur & Universite de Montreal
Montreal, Quebec, Canada
Universidad de Los Andes
Santiago, , Chile
CARE Hospitals
Banjara Hills, Hyderabad, India
Postgraduate Institute of Research, Chandigarh
Chandigarh, , India
Newcastle University
Newcastle upon Tyne, Tyne and Wear, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom
Royal Free Hospital
London, , United Kingdom
Guy's & St Thomas's Hospital
London, , United Kingdom
University of Nottingham
Nottingham, , United Kingdom
Countries
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References
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Mehta RL, Awdishu L, Davenport A, Murray PT, Macedo E, Cerda J, Chakaravarthi R, Holden AL, Goldstein SL. Phenotype standardization for drug-induced kidney disease. Kidney Int. 2015 Aug;88(2):226-34. doi: 10.1038/ki.2015.115. Epub 2015 Apr 8.
Yousif Z, Awdishu L. Drug-Induced Acute Kidney Injury Risk Prediction Models. Nephron. 2023;147(1):44-47. doi: 10.1159/000526267. Epub 2022 Sep 9.
Other Identifiers
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121651
Identifier Type: -
Identifier Source: org_study_id
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