NCT02962102

Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury

Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (ACTIVATE-AKI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: David Leaf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Critically Ill
• Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	Calcifediol	Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4
DRUG	Calcitriol	Calcitriol 4mcg orally daily x 5
DRUG	Placebos	Placebo (medium chain triglyceride oil) orally daily x 5

Timeline

• Start date: 2017-04-03
• Primary completion: 2020-07-16
• Completion: 2020-08-06
• First posted: 2016-11-11
• Last updated: 2025-09-29
• Results posted: 2022-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study