Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT02962102
The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney injury (AKI) in critically ill patients.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Boston, Massachusetts, 02115, United States
Decreased circulating levels of active vitamin D metabolites, including 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D (1,25D), are common in critically ill patients, and lower levels are independently associated with a higher risk of acute kidney injury (AKI). Further, administration of 25D and 1,25D attenuates AKI in animal models. The purpose of this study is to assess if administration of 25D and 1,25D decreases the incidence and severity of AKI in critically ill patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4
Calcitriol 4mcg orally daily x 5
Placebo (medium chain triglyceride oil) orally daily x 5
Time frame: 7 days
All-cause mortality within 7 days following randomization
Time frame: 7 days
Number of participants who received renal replacement therapy within 7 days following randomization
Time frame: 7 days
Average percentage change in serum creatinine assessed on days 1-7 as compared to day 0
Time frame: 7 days
Any of the following: 1) an increase in serum creatinine ≥50% compared to the immediate pre-randomization value; 2) new or progressive stage of oliguria; or 3) receipt of renal replacement therapy. Oliguria stages 1, 2, and 3 are defined as urine output (UOP) <0.5 ml/kg/h for 6-12h, <0.5 ml/kg/h for >12h, and <0.3 ml/kg/h for ≥24h or anuria for ≥12h, respectively.
Time frame: 7 days
Highest serum creatinine value on days 1 to 7
Time frame: 28 days
All-cause mortality assessed during the 28 days following randomization
Time frame: 28 days
28 minus the number of days in the ICU or hospital, with 0 assigned to patients who die before 28 days
Time frame: 7 days
Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
Time frame: 7 days
Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
Time frame: 7 days
Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
Time frame: 7 days
Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
Time frame: 7 days
Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days
David Leaf
Other
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (ACTIVATE-AKI)
Acronym: ACTIVATE-AKI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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