Acute Kidney InjuryDIRECTNCT02159209
The Drug Induced Renal Injury Consortium
An observational study of Acute Kidney Injury and Adverse Drug Reaction, run by Ravindra Mehta at 18 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Acute Kidney Injury, Adverse Drug Reaction, Acute Kidney Failure
- How many people
- 634 participants
- Where
- 18 sitesin 6 countries
- Study dates
- Feb 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
United States8 sites
St. Peter's Hospital
Albany, New York, 12208
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Jacobi Medical Center
New York, New York, 10461
University of California, San Diego
San Diego, California, 92103
Rady Children's Hospital
San Diego, California, 92123
United Kingdom5 sites
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
Royal Free Hospital
London, NW3 2QG
Guy's & St Thomas's Hospital
London, SE1 7EH
Newcastle University
Newcastle upon Tyne, Tyne and Wear, NE1 7RU
University of Nottingham
Nottingham, NG7 2RD
India2 sites
CARE Hospitals
Banjara Hills, Hyderabad
Postgraduate Institute of Research, Chandigarh
Chandigarh
About this study
Official title: The Genetic Contribution to Drug Induced Renal Injury: The Drug Induced Renal Injury Consortium (DIRECT)
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
- Medical subject headings
- Acute Kidney Injury, Drug-Related Side Effects and Adverse Reactions, Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
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.
Measured: DNA sample collected at time of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ravindra Mehta
- Sponsor type
- University, hospital or other
- Collaborators
- International Serious Adverse Event Consortium
- Responsible party
- Sponsor-investigator, Ravindra Mehta, University of California, San Diego
- Investigators
- Ravindra Mehta, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159209
- Sponsor's protocol ID
- 121651
- Acronym
- DIRECT
- Status last verified
- Apr 2016
- First submitted
- 26 Sep 2013
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25853333Yousif 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.
PubMed 36088907
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Genetic Contribution to Drug Induced Renal Injury: The Drug Induced Renal Injury Consortium (DIRECT)
- ClinicalTrials.gov ID
- NCT02159209
- Acronym / sponsor ID
- DIRECT / 121651
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- Ravindra MehtaUniversity, hospital or other
- Collaborators
- International Serious Adverse Event Consortium
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Background: PubMed 25853333Mehta 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.
- Derived from this study: PubMed 36088907Yousif 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravindra Mehta, MD principal investigator
University of California, San Diego
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Adverse Drug Reaction, run by Ravindra Mehta at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, United Kingdom, India, Bolivia, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify genes that predispose to dose dependent (Type A) or hypersensitivity (Type B) during drug induced nephrotoxicity. (time frame: At time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02159209, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.