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Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease (CLEAR)

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ClinicalTrials.gov Identifier: NCT02937350
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ian deBoer, University of Washington

Brief Summary:
The goal of this study is to better understand vitamin D catabolism and how it is affected by CKD and race. Specifically, the study team will evaluate the metabolic clearance of 25-hydroxyvitamin D3 in individuals with varying degrees of CKD and among participants who self-report race as Caucasian, African American or African. The long-term goal of this work is to enhance the clinical evaluation and treatment of impaired vitamin D metabolism.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: D6-25-hydroxyvitamin D3 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Calcifediol

Arm Intervention/treatment
Experimental: Study Population
D6-25-hydroxyvitamin D3
Drug: D6-25-hydroxyvitamin D3
Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3
Other Name: stable isotope deuterium-labeled 25(OH)D3




Primary Outcome Measures :
  1. Metabolic clearance of D6-25(OH)D3 [ Time Frame: 8 weeks ]
    Metabolic clearance is calculated as the administered dose of 25(OH)D3 divided by the area under the plasma concentration-time curve (AUC). AUC is calculated using the linear trapezoidal method.


Secondary Outcome Measures :
  1. AUC of D6-25(OH)D3 [ Time Frame: 8 weeks ]
    AUC is calculated using the linear trapezoidal method.

  2. Terminal half-life of D6-25(OH)D3 [ Time Frame: 8 weeks ]
    Terminal half-life is equal to ln2/k, where k is the slope of the terminal regression line estimated using ≥3 plasma concentrations.

  3. Volume of distribution of D6-25(OH)D3 [ Time Frame: 8 weeks ]
    Volume of distribution in the central compartment is calculated as dose/C0, where dose is the administered dose of 25(OH)D3 and C0 is the initial (estimated) concentration of drug in plasma.


Other Outcome Measures:
  1. Metabolic formation clearance of D6-25(OH)D3 metabolites. [ Time Frame: 8 weeks ]
    Metabolic formation clearance is calculated as the daughter metabolite plasma AUC divided by the AUC of D6-25(OH)D3 (metabolite/parent AUC ratio). AUC is calculated using the linear trapezoidal method.

  2. Change in the serum concentration of calcium [ Time Frame: 7 days ]
    Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 administration

  3. Change in the serum concentration of creatinine [ Time Frame: 7 days ]
    Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 administration

  4. Change in the serum concentration of AST [ Time Frame: 7 days ]
    Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 administration

  5. Change in the serum concentration of ALT [ Time Frame: 7 days ]
    Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration



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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 years
  • Self-reported race Caucasian, African American, or African
  • Serum total 25(OH)D 10-50 ng/mL
  • Estimated GFR:

    • 60 mL/min/1.73m2 (N=40) 15-45 mL/min/1.73m2 (N=40) <15 mL/min/1.73m2, treated with hemodialysis (N=40)

Exclusion Criteria:

  • Primary hyperparathyroidism
  • Gastric bypass
  • Tuberculosis or sarcoidosis
  • Current pregnancy
  • Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)
  • Use of vitamin D3, or vitamin D2 supplements exceeding a mean daily dose of 400 IU, within 3 months (wash-out allowed)
  • Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed)
  • Serum calcium > 10.1 mg/dL
  • Hemoglobin < 10 g/dL

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): NCT02937350


Contacts
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Contact: Laura Curtin 2062213938 LCurtin@Nephrology.washington.edu
Contact: Ashveena Dighe 2067444029 ashveena@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Laura Curtin    206-221-3938      
Sponsors and Collaborators
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Ian de Boer, MD, MS University of Washington

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Responsible Party: Ian deBoer, Professor, Medicine/Nephrology, University of Washington
ClinicalTrials.gov Identifier: NCT02937350     History of Changes
Other Study ID Numbers: 42430
R01DK099199 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ian deBoer, University of Washington:
chronic kidney disease
vitamin d catabolism
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Hydroxycholecalciferols
Calcifediol
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents