Phase 2
N=150
Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury
Critically Ill · Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT02962102 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Death Within 7 Days — 4; 9; 6 Participants — p=0.52
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Calcifediol (Drug); Calcitriol (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- David Leaf
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death Within 7 Days |
4; 9; 6 | 0.52 |
| PRIMARY Number of Participants Who Received Renal Replacement Therapy Within 7 Days |
1; 1; 4 | 0.20 |
| PRIMARY Relative Average Change in Serum Creatinine From Day 0 to Days 1-7 |
-2.3; -7.1; -7.4 | 0.44 |
| SECONDARY Number of Participants With New or Worsening Stage of AKI, Defined by KDIGO Guidelines |
20; 23; 19 | — |
| SECONDARY Peak Serum Creatinine (mg/dl) |
1.2; 1.3; 1.2 | — |
| SECONDARY 28-day Mortality |
10; 16; 10 | — |
| SECONDARY ICU- and Hospital-free Days |
20; 16; 11; 5; 4; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02962102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.