Not provided
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 study is about possible protective effects of paricalcitol (Zemplar) upon inflammation, blood pressure and kidney function. Kidney Inflammation occurs when white blood cells become abnormally stimulated and accumulate in the kidney and cause damage to the kidney. The purpose of this study is to determine if paricalcitol helps improve kidney injury, blood pressure control and kidney function in patients with chronic kidney disease. The study will last about 7 weeks and involves about 8 visits to the medical center.
We hypothesize that use of paricalcitol in patients with chronic kidney disease will lead to improvement in oxidative stress, inflammation, endothelial function and subsequently ambulatory blood pressures and glomerular filtration rate. We will pursue our hypothesis by the three specific aims:
Aim 1: To compare oxidative stress markers in patients treated with paricalcitol before and after the study. Aim 2: To measure endothelial function by flow mediated dilation in patients with chronic kidney disease before and after paricalcitol. Aim 3: To measure actigraphy guided ambulatory blood pressure and GFR in the absence of changes in anti-hypertensive medications in patients with chronic kidney disease.
The study will be double blind randomized pilot trial in 24 patients with chronic kidney disease with 1:1:1 allocation to paricalcitol 1 microgram: paricalcitol 2 microgram: Placebo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 1 mcg paricalcitol |
|
| 2 | Active Comparator | 2 mcg paricalcitol |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paricalcitol | Drug | 1 mcg or 2 mcg for 4 weeks. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Inflammatory Effects of Paricalcitol | change in hsCRP level from baseline to 4 weeks | 6 weeks |
| Endothelial Protectant Effects of Paricalcitol | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Paricalcitol on Hypertension | 6 weeks | |
| Effect of Paricalcitol on Kidney Function | 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rajiv Agarwal, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richard A. Rodebush VA Medical Center | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18606901 | Result | Alborzi P, Patel NA, Peterson C, Bills JE, Bekele DM, Bunaye Z, Light RP, Agarwal R. Paricalcitol reduces albuminuria and inflammation in chronic kidney disease: a randomized double-blind pilot trial. Hypertension. 2008 Aug;52(2):249-55. doi: 10.1161/HYPERTENSIONAHA.108.113159. Epub 2008 Jul 7. |
Not provided
Not provided
Not provided
169 patients screened from renal speciality clinics from November 2006 to June 2007
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1 | 1 mcg paricalcitol |
| FG001 | 2 | 2 mcg paricalcitol |
| FG002 | 3 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1 | 1 mcg paricalcitol |
| BG001 | 2 | 2 mcg paricalcitol |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Anti-Inflammatory Effects of Paricalcitol | change in hsCRP level from baseline to 4 weeks | Posted | Mean | 95% Confidence Interval | micrograms | 6 weeks |
|
Not provided
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 | 1 | 1 mcg paricalcitol |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajiv Agarwal | Indiana University | 317-988-2241 | ragarwal@iupui.edu |
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007249 | Inflammation |
| D006973 | Hypertension |
| 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 | Placebo |
|
| 3 |
Placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Endothelial Protectant Effects of Paricalcitol | Not Posted | 6 weeks |
| Secondary | Effect of Paricalcitol on Hypertension | Not Posted | 6 weeks |
| Secondary | Effect of Paricalcitol on Kidney Function | Not Posted | 6 weeks |
| EG001 | 2 | 2 mcg paricalcitol |
| EG002 | 3 | Placebo |
Not provided
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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |