The Drug Induced Renal Injury Consortium (DIRECT)

Ravindra Mehta

Status: Completed

Conditions: Kidney Failure; Adverse Drug Reaction; Acute Kidney Failure; Acute Kidney Injury; Kidney Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02159209

121651

Details and patient eligibility

About

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.

Enrollment: 634 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

634 participants in 1 patient group

Drug Induced Renal Injury (DIRI)

Description:

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.