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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:April 3, 2017
End Date:November 1, 2019
Contact:David E Leaf, MD, MMSc
Email:deleaf@partners.org
Phone:617-732-5500

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


Inclusion Criteria:

- Age ≥ 18

- Admitted to the ICU within 48h prior to enrollment

- Likely to remain in the ICU (alive) for ≥72h

- Naso/orogastric tube or ability to swallow

- High risk of severe AKI

Exclusion Criteria:

- Serum total calcium > 9.0 mg/dl or phosphate > 6.0 mg/dL within previous 48h

- Currently receiving oral calcium supplementation

- Ingestion of vitamin D3 >1,000 IU/day or any 25-hydroxyvitamin D or
1,25-dihydroxyvitamin D during the previous 7 days

- AKI stage 2 or 3 (based on KDIGO serum creatinine and/or urine output criteria)

- History of transplantation or receiving chronic (>7days) of immunosuppressive
medications (not including glucocorticoid steroids at a dose less than or equivalent
to prednisone 20 mg/day)

- Neutropenia in the previous 48h

- Active primary parathyroid disease, active granulomatous disease, or symptomatic
nephrolithiasis in the previous 3 months

- Receiving cytochrome P450 inhibitors

- Chronic Kidney Disease stage V or End Stage Renal Disease

- Hemoglobin < 7 g/dL

- GI malabsorption

- Prisoner

- Pregnancy or breast feeding
We found this trial at
1
site
Brigham and Women's Hosp
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-5951
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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