The Drug Induced Renal Injury Consortium
- Conditions
- Acute Kidney FailureKidney DiseaseAcute Kidney InjuryKidney FailureAdverse Drug Reaction
- Registration Number
- NCT02159209
- Lead Sponsor
- Ravindra Mehta
- Brief Summary
Some medications are known to cause kidney damage because the person is allergic to the medication while others cause direct damage to the kidney because they are toxic at certain concentrations. Risk factors for developing kidney damage have been identified for some medications but not for all. Patients who are exposed to these important medications and develop problems with their kidneys may have some genetic risk. The purpose of this study is to determine the genetic risk factors for drug induced kidney injury. A better understanding of the role of genetics for the development of kidney injury from medications will allow us to better select medications, improve effectiveness of treatment and minimize harm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 634
- Patients age 2 years and older
- 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
- Patients with a history of or have a kidney transplant
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identify genes that predispose to dose dependent (Type A) or hypersensitivity (Type B) during drug induced nephrotoxicity. At time of enrollment Blood Draw (20 cc) and urine collection (80cc)
- Secondary Outcome Measures
Name Time Method To identify specific alterations in drug metabolism pathways that contribute to drug induced renal injury with different drugs. DNA sample collected at time of enrollment. We will perform a GWAS to examine the association of common genetic variants with the development of DIRI. For assessing association between a common SNP and the risk of DIRI, association tests will be undertaken to compare genotype frequencies between cases and controls. We will use logistic regression models under the assumption of an additive genetic model and incorporate potential confounders and covariates. Dominant, recessive models will also be checked through alternative coding of the genotype for SNPs approaching significance.
Trial Locations
- Locations (18)
St. Peter's Hospital
🇺🇸Albany, New York, United States
Universidad de Los Andes
🇨🇱Santiago, Chile
University of California, San Diego
🇺🇸San Diego, California, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Universidad del Valle, Cochabamba
🇧🇴Cochabamba, Bolivia
CARE Hospitals
🇮🇳Banjara Hills, Hyderabad, India
University of Colorado
🇺🇸Aurora, Colorado, United States
Royal Free Hospital
🇬🇧London, United Kingdom
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
Jacobi Medical Center
🇺🇸New York, New York, United States
Newcastle University
🇬🇧Newcastle upon Tyne, Tyne and Wear, United Kingdom
Hopital Sacre Coeur & Universite de Montreal
🇨🇦Montreal, Quebec, Canada
St James's University Hospital
🇬🇧Leeds, West Yorkshire, United Kingdom
Rady Children's Hospital
🇺🇸San Diego, California, United States
Guy's & St Thomas's Hospital
🇬🇧London, United Kingdom
Postgraduate Institute of Research, Chandigarh
🇮🇳Chandigarh, India
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
University of Nottingham
🇬🇧Nottingham, United Kingdom