Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

NCT ID: NCT02320240

Last Updated: 2016-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3255526 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with Serotonin-norepinephrine reuptake inhibitors (SNRIs) as compared to Selective serotonin reuptake inhibitors (SSRIs), two classes of medication used for the treatment of depression.

Detailed Description

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We plan to conduct retrospective population-based cohort studies within eight administrative databases from Canada, the United States, and the United Kingdom. Within each cohort, a nested case-control analysis will be performed to estimate incidence rate ratios (RR) of AKI associated with SNRIs compared to SSRIs using conditional logistic regression, with adjustment for high-dimensional propensity scores at baseline. The overall effect across sites will then be estimated using meta-analytic methods.

Conditions

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Depression Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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SNRI Exposure Group

Patients who received a new prescription for an SNRI (duloxetine, venlafaxine, or desvenlafaxine at any dosage) with no prescriptions for either SNRI or SSRI in the prior year.

Duloxetine

Intervention Type DRUG

Current exposure to Duloxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Venlafaxine

Intervention Type DRUG

Current exposure to Venlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Desvenlafaxine

Intervention Type DRUG

Current exposure to Desvenlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

SSRI Exposure Group

Patients who received a new prescription for an SSRI (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline at any dosage) with no prescriptions for either SSRI or SNRI in the prior year.

Citalopram

Intervention Type DRUG

Current exposure to Citalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Escitalopram

Intervention Type DRUG

Current exposure to Escitalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Fluoxetine

Intervention Type DRUG

Current exposure to Fluoxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Fluvoxamine

Intervention Type DRUG

Current exposure to Fluvoxamine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Paroxetine

Intervention Type DRUG

Current exposure to Paroxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Sertraline

Intervention Type DRUG

Current exposure to Sertraline will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Interventions

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Duloxetine

Current exposure to Duloxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Intervention Type DRUG

Venlafaxine

Current exposure to Venlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Intervention Type DRUG

Desvenlafaxine

Current exposure to Desvenlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Intervention Type DRUG

Citalopram

Current exposure to Citalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Intervention Type DRUG

Escitalopram

Current exposure to Escitalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Intervention Type DRUG

Fluoxetine

Current exposure to Fluoxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Intervention Type DRUG

Fluvoxamine

Current exposure to Fluvoxamine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Intervention Type DRUG

Paroxetine

Current exposure to Paroxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Intervention Type DRUG

Sertraline

Current exposure to Sertraline will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010.

Exclusion Criteria

* They were \<12 years old at the time of cohort entry.
* They had less than 1 year of information in the database prior to the date of cohort entry.
* They had a prescription of an SNRI or SSRI in the year before the date of cohort entry.
* They had a prescription for both an SNRI and an SSRI on the day of cohort entry.
* They had a history of chronic kidney disease (including kidney transplantation and dialysis) or AKI in the year preceding cohort entry.
* The subject was previously included in the cohort.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Drug Safety and Effectiveness Network, Canada

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Canadian Network for Observational Drug Effect Studies, CNODES

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Ernst, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University

Locations

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Lady Davis Institute for Medical Research, Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Renoux C, Lix LM, Patenaude V, Bresee LC, Paterson JM, Lafrance JP, Tamim H, Mahmud SM, Alsabbagh MW, Hemmelgarn B, Dormuth CR, Ernst P; Canadian Network of Observational Drug Effect Studies (CNODES) Investigators. Serotonin-Norepinephrine Reuptake Inhibitors and the Risk of AKI: A Cohort Study of Eight Administrative Databases and Meta-Analysis. Clin J Am Soc Nephrol. 2015 Oct 7;10(10):1716-22. doi: 10.2215/CJN.11271114. Epub 2015 Jul 31.

Reference Type RESULT
PMID: 26231193 (View on PubMed)

Related Links

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http://www.cnodes.ca

This organization's website describing general functions, other CNODES projects, and investigator profiles.

Other Identifiers

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Q12-08

Identifier Type: -

Identifier Source: org_study_id

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