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Completed

NCT Number: NCT02937350

Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease

The goal of this study is to better understand vitamin D catabolism and how it is affected by CKD and race.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D6-25-hydroxyvitamin D3

Drug

Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3

Other names: stable isotope deuterium-labeled 25(OH)D3

Primary outcomes

  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. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.

Secondary outcomes

  1. AUC of D6-25(OH)D3

    Time frame: 8 weeks

    AUC is calculated using the linear trapezoidal method. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.

  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. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.

  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. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.

Other outcomes

  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. Concentration was measured at 5 minutes, 4 hours, and at 1, 4, 7, 14, 21, 28, 42, and 56 days post administration.

  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: Baseline, 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: Baseline, 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: Baseline, 7 days

    Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: CLEAR

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Oct 18, 2016
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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