Who is sponsoring NCT02518516?

NCT02518516 is sponsored by Canadian Network for Observational Drug Effect Studies, CNODES.

What condition does NCT02518516 study?

NCT02518516 studies Hypercholesterolemia.

What drugs are being tested in NCT02518516?

Interventions: Rosuvastatin (≥10 mg), Atorvastatin (≥20 mg), Simvastatin (≥40 mg), Fluvastatin, Pravastatin, Lovastatin, Atorvastatin (<20mg), Simvastatin (<40 mg).

What is the status of NCT02518516?

NCT02518516 is currently COMPLETED.

Last reviewed 2016-03-11 · How we verify

Use of High Potency Statins and Rates of Admission for Acute Kidney Injury: Multicenter, Retrospective Observational Analysis of Administrative Databases

NCT02518516 COMPLETED

Statins are a class of cholesterol lowering medications that are prescribed for the prevention and treatment of cardiovascular disease. The purpose of this study is to determine if there is an excess risk of acute kidney injury (AKI) with high potency statins compared to low potency statins. The investigators will carry out separate population based cohort studies using administrative health care databases in nine jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a statin, with follow-up until hospitalization for AKI. Analyses will be done separately for groups of patients with and without chronic kidney disease. The results from the separate sites will be combined in a meta-analysis to provide an overall assessment of the risk of AKI in new statin users.

Details

Lead sponsor	Canadian Network for Observational Drug Effect Studies, CNODES
Status	COMPLETED
Enrolment	2067639
Start date	2011-01
Completion	2013-01

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin (≥10 mg)
Atorvastatin (≥20 mg)
Simvastatin (≥40 mg)
Fluvastatin
Pravastatin
Lovastatin
Atorvastatin (<20mg)
Simvastatin (<40 mg)

Primary outcomes

Number of patients hospitalized for acute kidney injury — Patients will be followed from the date of study cohort entry until either hospitalization for acute kidney injury or censoring (whichever occurs first), or will be assessed for up to 24 months.
Patients hospitalized for acute kidney injury (including but not limited to hypertensive renal disease with renal failure, chronic glomerulonephiritis, and renal sclerosis) with any of the following diagnostic codes: ICD-9 584, 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.

Countries

Canada