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

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ClinicalTrials.gov Identifier: NCT02962102
Recruitment Status : Recruiting
First Posted : November 11, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
David Leaf, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Critically Ill Acute Kidney Injury Drug: Calcifediol Drug: Calcitriol Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (ACTIVATE-AKI)
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Calcifediol
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
Drug: Calcifediol
Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4

Experimental: Calcitriol
Calcitriol 4mcg PO/NGT/OGT daily x 5 days
Drug: Calcitriol
Calcitriol 4mcg PO/NGT/OGT daily x 5

Placebo Comparator: Placebo
Equal volume of medium chain triglyceride (MCT) oil daily x 5 days
Drug: Placebos
Placebo (medium chain triglyceride oil) daily x 5




Primary Outcome Measures :
  1. Kidney Injury [ Time Frame: 7 days ]
    Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days


Secondary Outcome Measures :
  1. New or worsening stage of AKI, defined by KDIGO guidelines [ Time Frame: 7 days ]
  2. Peak serum creatinine (mg/dl) [ Time Frame: 7 days ]
  3. 28-day mortality [ Time Frame: 28 days ]
  4. Urinary injury markers (neutrophil gelatinase-associated lipocalin [NGAL], interleukin 18 [IL-18], and kidney injury molecule-1 [KIM-1]) [ Time Frame: 5 days ]
  5. Organ-failure free days [ Time Frame: 7 days ]
    Assessed by daily Sequential Organ Failure Assessment (SOFA) scores

  6. Hypercalcemia, defined as serum total calcium > 10.7 mg/dl [ Time Frame: 7 days ]
  7. ICU- and hospital-free days [ 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


Other Outcome Measures:
  1. Kidney Injury - Subgroup analysis based on time zero 25-hydroxyvitamin D level above versus below the median [ Time Frame: 7 days ]
    Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days

  2. Kidney Injury - Subgroup analysis based on the presence or absence of AKI on enrollment [ Time Frame: 7 days ]
    Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days

  3. Kidney Injury - Subgroup analysis based on APACHE II score on enrollment above versus below the median [ Time Frame: 7 days ]
    Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days

  4. Kidney Injury - Subgroup analysis based on ICU type (medical versus surgical) [ Time Frame: 7 days ]
    Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days

  5. Kidney Injury - Subgroup analysis based on the presence or absence of sepsis on enrollment [ Time Frame: 7 days ]
    Composite of daily serum creatinine, need for renal replacement therapy (RRT), or death within 7 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962102


Contacts
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Contact: David E Leaf, MD, MMSc 617-732-5500 deleaf@partners.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: David E. Leaf, M.D.    617-732-5951    DELEAF@partners.org   
Sponsors and Collaborators
David Leaf
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: David E Leaf, MD, MMSc Brigham and Women's Hospital

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Responsible Party: David Leaf, Assistant Professor of Medicine, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02962102     History of Changes
Other Study ID Numbers: 2016P002527
5K23DK106448 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Calcitriol
Acute Kidney Injury
Critical Illness
Wounds and Injuries
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vitamin D
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents