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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK099199 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Population | Experimental | D6-25-hydroxyvitamin D3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D6-25-hydroxyvitamin D3 | Drug | Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Clearance of D6-25(OH)D3 | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of D6-25(OH)D3 | 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. | 8 weeks |
| Terminal Half-life of D6-25(OH)D3 |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic Formation Clearance of D6-25(OH)D3 Metabolites. | 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. | 8 weeks |
Inclusion Criteria:
Age ≥ 18 years
Self-reported race Caucasian, African American, or African
Serum total 25(OH)D 10-50 ng/mL
Estimated GFR:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian de Boer, MD, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36404469 | Derived | Best CM, Thummel KE, Hsu S, Lin Y, Zelnick LR, Kestenbaum B, Kushnir MM, de Boer IH, Hoofnagle AN. The plasma free fraction of 25-hydroxyvitamin D3 is not strongly associated with 25-hydroxyvitamin D3 clearance in kidney disease patients and controls. J Steroid Biochem Mol Biol. 2023 Feb;226:106206. doi: 10.1016/j.jsbmb.2022.106206. Epub 2022 Oct 28. | |
| 33115916 | Derived | Hsu S, Zelnick LR, Lin YS, Best CM, Kestenbaum B, Thummel KE, Rose LM, Hoofnagle AN, de Boer IH. Differences in 25-Hydroxyvitamin D Clearance by eGFR and Race: A Pharmacokinetic Study. J Am Soc Nephrol. 2021 Jan;32(1):188-198. doi: 10.1681/ASN.2020050625. Epub 2020 Oct 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Controls | Healthy controls defined as normal eGFR (>60 ml/min per 1.73m2) |
| FG001 | CKD Group | CKD group defined as those with eGFR <60ml/min per 1.73 m2) |
| FG002 | Kidney Failure Group | Kidney failure group defined as those with ESKD treated with dialysis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Controls | Healthy controls defined as normal eGFR (>60 ml/min per 1.73m2) |
| BG001 | CKD Group | CKD group defined as those with eGFR <60ml/min per 1.73 m2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Metabolic Clearance of D6-25(OH)D3 | 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. | Posted | Mean | Standard Deviation | milliliter per day (ml/d) | 8 weeks |
|
8 weeks
Everyone had the same treatment, so it was more appropriate to summarize AEs for the whole group. Adverse events were not collected separately per arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants (N=87) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain or sensation in arm during infusion | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian de Boer | University of Washington | 206-616-5403 | IDeBoer@Nephrology.washington.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2017 | May 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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.
| 8 weeks |
| Volume of Distribution of D6-25(OH)D3 | 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. | 8 weeks |
| Change in the Serum Concentration of Calcium | Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 administration | 7 days |
| Change in the Serum Concentration of Creatinine | Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 administration | Baseline, 7 days |
| Change in the Serum Concentration of AST | Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 administration | Baseline, 7 days |
| Change in the Serum Concentration of ALT | Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration | Baseline, 7 days |
| BG002 | Kidney Failure Group | Kidney failure group defined as those with ESKD treated with dialysis |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Vitamin-D3 Supplement Use | Number | participants |
|
| OG002 |
| Kidney Failure Group |
Kidney failure group defined as those with ESKD treated with dialysis |
|
|
| Secondary | AUC of D6-25(OH)D3 | 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. | Posted | Mean | Standard Deviation | nanograms x day/mL (ngxd/mL) | 8 weeks |
|
|
|
| Secondary | Terminal Half-life of D6-25(OH)D3 | 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. | Posted | Mean | Standard Deviation | days (d) | 8 weeks |
|
|
|
| Secondary | Volume of Distribution of D6-25(OH)D3 | 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. | Posted | Mean | Standard Deviation | Liters (L) | 8 weeks |
|
|
|
| Other Pre-specified | Metabolic Formation Clearance of D6-25(OH)D3 Metabolites. | 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. | Posted | Mean | Standard Deviation | ratio | 8 weeks |
|
|
|
| Other Pre-specified | Change in the Serum Concentration of Calcium | Change in the serum concentration of calcium from baseline to 7 days after 25(OH)D3 administration | Posted | Mean | Standard Deviation | milligrams/deciliter (mg/dl) | 7 days |
|
|
|
| Other Pre-specified | Change in the Serum Concentration of Creatinine | Change in the serum concentration of creatinine from baseline to 7 days after 25(OH)D3 administration | Posted | Mean | Standard Deviation | milligrams/deciliter (mg/dl) | Baseline, 7 days |
|
|
|
| Other Pre-specified | Change in the Serum Concentration of AST | Change in the serum concentration of AST from baseline to 7 days after 25(OH)D3 administration | Posted | Mean | Standard Deviation | units/Liter (u/L) | Baseline, 7 days |
|
|
|
| Other Pre-specified | Change in the Serum Concentration of ALT | Change in the serum concentration of ALT from baseline to 7 days after 25(OH)D3 administration | Posted | Mean | Standard Deviation | units/Liter (u/L) | Baseline, 7 days |
|
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|
| 87 |
| 1 |
| 87 |
| 16 |
| 87 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |