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| Name | Class |
|---|---|
| International Serious Adverse Event Consortium | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Identify genes that predispose to dose dependent (Type A) or hypersensitivity (Type B) during drug induced nephrotoxicity. | Blood Draw (20 cc) and urine collection (80cc) | At time of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| To identify specific alterations in drug metabolism pathways that contribute to drug induced renal injury with different drugs. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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This is a prospective observational cohort study of patients who have developed DIRI. Patients will be identified through two main approaches;
Patients who developed DIRI in their previous care provided will be identified through a review of kidney biopsy logs or nephrology consults previously made.
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| Name | Affiliation | Role |
|---|---|---|
| Ravindra Mehta, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California, San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25853333 | Background | 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. | |
| 36088907 | Derived | 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. |
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| DNA sample collected at time of enrollment. |
| San Diego |
| California |
| 92103 |
| United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| St. Peter's Hospital | Albany | New York | 12208 | United States |
| Jacobi Medical Center | New York | New York | 10461 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | 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 | NE1 7RU | United Kingdom |
| St James's University Hospital | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Guy's & St Thomas's Hospital | London | SE1 7EH | United Kingdom |
| University of Nottingham | Nottingham | NG7 2RD | United Kingdom |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D064419 | Chemically-Induced Disorders |
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