The Drug Induced Renal Injury Consortium

NCT02159209 | Completed

• 1 other identifier: 121651
• Study Type: observational
• Target: 634
• Locations: 6 countries
• Sites: 18

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.

Conditions

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

Keywords

Acute Kidney Injury; Adverse Drug Reaction; Acute Kidney Failure; Kidney; Kidneys

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational cohort study of patients who have developed DIRI. Patients will be identified through two main approaches; 1. Recall and review of medical records of patients who were suspected to have DIRI 2. Concurrent identification of patient under active treatment. Patients who developed DIRI in their previous care provided will be identified through a review of kidney biopsy logs or nephrology consults previously made.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ravindra Mehta: lead
• International Serious Adverse Event Consortium: collaborator

Study Sites (18)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St. Peter's Hospital

Albany, New York, 12208, United States

Location

Jacobi Medical Center

New York, New York, 10461, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Universidad del Valle, Cochabamba

Cochabamba, Bolivia

Location

Hopital Sacre Coeur & Universite de Montreal

Montreal, Quebec, Canada

Location

Universidad de Los Andes

Santiago, Chile

Location

CARE Hospitals

Banjara Hills, Hyderabad, India

Location

Postgraduate Institute of Research, Chandigarh

Chandigarh, India

Location

Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE1 7RU, United Kingdom

Location

St James's University Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Guy's & St Thomas's Hospital

London, SE1 7EH, United Kingdom

Location

University of Nottingham

Nottingham, NG7 2RD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 25853333 BACKGROUND

• 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.

  PMID: 36088907 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Plasma, serum, and urine stored for further analysis of biomarkers * Urinary chemistry * Urinary microscopy * DNA sample

MeSH Terms

Conditions

Acute Kidney Injury; Drug-Related Side Effects and Adverse Reactions; Renal Insufficiency; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chemically-Induced Disorders

Study Officials

• Ravindra Mehta, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: June 9, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

US (8); IN (2); GB (5); CL (1); CA (1); BO (1)