Clinical trial NCT02320240: Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury
Official title: Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Acute Kidney Injury
Keywords: antidepressants
acute kidney injury
SNRI
renal failure
duloxetine
CNODES
Lead sponsor: Canadian Network for Observational Drug Effect Studies, CNODES
Sponsor class: OTHER
Collaborators: name: Drug Safety and Effectiveness Network, Canada
name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-12-19
Enrollment: 3255526
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort will be formed of all patients in the databases aged 12 or older (or 65 or older in some of the databases) with a first prescription of an antidepressant of the SNRI or SSRI class of any dose between January 1, 1997 and March 31, 2010. The databases to be included are eight administrative databases from Canada (Alberta, Manitoba, Nova Scotia, Ontario, Quebec, and Saskatchewan), the United States (US MarketScan), and the United Kingdom (CPRD).

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acute Kidney Injury (AKI)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Lady Davis Institute for Medical Research, Jewish General Hospital
state: Quebec
Study officials:
affiliation: Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University
name: Pierre Ernst, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.