Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-01-29 @ 7:40 AM
Study NCT ID:
NCT02962102
Status:
COMPLETED
Last Update Posted:
2025-09-29
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury
Sponsor:
David Leaf
Organization:
Study Overview
Official Title:
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (ACTIVATE-AKI)
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTIVATE-AKI
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5K23DK106448 | NIH | None | https://reporter.nih.gov/quic… | View |