Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).
Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabolic stressors is a known complication of CKD. Since these metabolic abnormalities are also known to contribute to the pathogenesis of cardiovascular disease, they are important potential therapeutic targets in CKD.
This study will test whether oral paricalcitol, an active form of vitamin D, will improve glucose tolerance, immune cell function, and reduce oxidative stress in people with stage 3-4 chronic kidney disease.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol followed by placebo | Active Comparator | Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. |
|
| Placebo followed by paricalcitol | Active Comparator | Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol | Drug | Two 1 mcg soft gels by mouth daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Area Under the Curve (AUC) | Glucose AUC during a 2-hour oral glucose tolerance test | 8 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ian H 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 |
|---|---|---|---|
| 22913981 | Result | de Boer IH, Sachs M, Hoofnagle AN, Utzschneider KM, Kahn SE, Kestenbaum B, Himmelfarb J. Paricalcitol does not improve glucose metabolism in patients with stage 3-4 chronic kidney disease. Kidney Int. 2013 Feb;83(2):323-30. doi: 10.1038/ki.2012.311. Epub 2012 Aug 22. |
Not provided
Not provided
Not provided
Participants were recruited from 2010 through 2011 from Nephrology clinics associated with the University of Washington.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol Followed by Placebo | Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. |
| FG001 | Placebo Followed by Paricalcitol | Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol Followed by Placebo | Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. |
| BG001 | Placebo Followed by Paricalcitol |
| 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 | Glucose Area Under the Curve (AUC) | Glucose AUC during a 2-hour oral glucose tolerance test | Posted | Geometric Mean | Geometric Coefficient of Variation | mg*min/dL | 8 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | During/After Paricalcitol |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia | Endocrine disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian H. de Boer, MD, MS, Associate Professor of Medicine | University of Washington | 2066165403 | deboer@u.washington.edu |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C084656 | paricalcitol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Two soft gels by mouth daily for 8 weeks |
|
Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 22 |
| 10 |
| 22 |
| EG001 | During/After Placebo | 0 | 21 | 7 | 21 |
| Elevated serum creatinine | Metabolism and nutrition disorders |
|
| Fistula placement | Metabolism and nutrition disorders |
|
| Renal artery stent | Metabolism and nutrition disorders |
|
| Dyspnea with palpitations and lightheadedness | Cardiac disorders |
|
| Dyspnea | Cardiac disorders |
|
| Elevated blood pressure | Cardiac disorders |
|
| Bradycardia | Cardiac disorders |
|
| Low back pain | Musculoskeletal and connective tissue disorders |
|
| Muscle cramps | Musculoskeletal and connective tissue disorders |
|
| Paresthesias | Musculoskeletal and connective tissue disorders |
|
| Gout flare | Musculoskeletal and connective tissue disorders |
|
| Fever | Infections and infestations |
|
| Common cold | Infections and infestations |
|
| Allergies | Infections and infestations |
|
| Vertigo | Nervous system disorders |
|
| Rash | Musculoskeletal and connective tissue disorders |
|
| Cataract surgery | Eye disorders |
|
| Skin cancer removal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
Not provided
| 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 |