Antidepressant doses under scrutiny for kidney patients
NCT ID NCT07531173
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study examined whether starting a higher dose of two common antidepressants (venlafaxine and duloxetine) increases the risk of emergency visits, hospital stays, or death within 30 days in older adults with chronic kidney disease. Researchers analyzed health records from over 8,600 people aged 66 and older with low kidney function. The goal was to gather safety information, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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8,688 people
The number who actually took part.
- Started
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Sep 2008
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults aged 66 years or older with low kidney function (eGFR \<45 mL/min per 1.73 m2 but not receiving dialysis or having a history of kidney transplantation) who have filled a new outpatient prescription of oral venlafaxine or duloxetine between 2008 and 2025 in Ontario.
- Ages
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66 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The cohort will include all older adults (≥66 years) with an eGFR \<45 mL/min per 1.73 m2 (not receiving dialysis or having a history of kidney transplantation) who received a new outpatient prescription for oral venlafaxine or duloxetine between January 1, 2008, and December 1, 2025. The age criterion is set to guarantee that individuals in this population have had at least one year of prior prescription drug coverage. The date when the prescription was filled will serve as the patient's entry or index date for the cohort, with each patient entering the cohort only once. Exclusion Criteria: * Individuals with missing administrative database number, missing or invalid age (\<0 or \>105 years), missing or invalid sex, death on or before the index date, non-Ontario resident (for Ontario data), or non-Alberta residents (for Alberta data). * Individuals less than 66 years of age on the index date. * Those with evidence of any study drug prescription 180 days before the index date (to restrict to new users only). * Individuals with more than one study drug prescription on the index date, as this complicates the ability to ascertain the prescribed dose accurately. * Evidence of clinically non-meaningful venlafaxine or duloxetine doses (doses that are either too low or too high). The recommended dose range for venlafaxine is 37.5 to 150 mg per day, and for duloxetine is 30 to 120 mg per day. * Individuals with end-stage renal disease, chronic dialysis, or a kidney transplant prior to the index date. * Evidence with hospital discharge or emergency department visit in the two days prior to or on the index date to ensure a new outpatient prescription. Individuals with no serum creatinine lab value in the 0-365 days prior to the index date. * Individuals with unstable baseline kidney function: If the most recent serum creatinine test prior to the index date was an inpatient test \[ER or hospitalization\], and there is not at least one 'outpatient' serum creatinine in the year before test date 1, OR If the most recent prior serum creatinine test prior to the index date was an inpatient test \[ER or hospitalization\], and while there is at least 'outpatient' serum creatinine test in the year before, the most recent outpatient test prior to differs by an eGFR 10 mL/min/1.73 m2 or more from the value on \<test date 1\>. In Ontario, it has been shown that outpatient serum creatinine measurements in the province, conducted on a single occasion, indicate stable values. * The investigators restrict to the first prescription in individuals with more than one eligible prescription. The date of this prescription will be the index date (the date from which outcomes start being assessed).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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Other studies related to the condition(s) this trial covers.
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