Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Depression Clinical Trial

— SNRI-AKI  

Official title:

Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320240
• Other study ID #: Q12-08
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: March 11, 2016
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: March 2016
• Source: Canadian Network for Observational Drug Effect Studies, CNODES
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3255526
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Depression

Intervention

Drug:
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Lady Davis Institute for Medical Research, Jewish General Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Canadian Network for Observational Drug Effect Studies, CNODES	Canadian Institutes of Health Research (CIHR), Drug Safety and Effectiveness Network, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 Inhibi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury (AKI)	AKI will be defined as patients hospitalized with one of the following diagnosis codes for AKI in any of the listed diagnoses: ICD-9-CM codes 584, 584.5, 584.6, 584.7, 584.8, or 584.9; ICD-10 N17, N17.0, N17.1, N17.2, N17.8, or N17.9.	2 years	Yes

External Links

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