The Drug Induced Renal Injury Consortium

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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Key information

Conditions

Acute Kidney Injury Acute Kidney Failure Adverse Drug Reaction Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Disease Kidney Diseases Kidney Failure Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad del Valle, Cochabamba, Cochabamba, Bolivia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Identify genes that predispose to dose dependent (Type A) or hypersensitivity (Type B) during drug induced nephrotoxicity.

Time frame: At time of enrollment

Blood Draw (20 cc) and urine collection (80cc)

Secondary outcomes

To identify specific alterations in drug metabolism pathways that contribute to drug induced renal injury with different drugs.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ravindra Mehta

Other

Collaborators

International Serious Adverse Event Consortium

Registry information

Official study title

The Genetic Contribution to Drug Induced Renal Injury: The Drug Induced Renal Injury Consortium (DIRECT)

Acronym: DIRECT

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jun 9, 2014
Registry last updated: Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed