N/A
Completed N=24
Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
Source: ClinicalTrials.gov NCT00428246 ↗Enrolled (actual)
24
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Anti-Inflammatory Effects of Paricalcitol — .8; .5; 1.5 micrograms
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-Inflammatory Effects of Paricalcitol |
.8; .5; 1.5 | — |
| PRIMARY Endothelial Protectant Effects of Paricalcitol |
— | — |
| SECONDARY Effect of Paricalcitol on Hypertension |
— | — |
| SECONDARY Effect of Paricalcitol on Kidney Function |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients with chronic kidney disease with estimated GFR of 30 mL/minute or more.
- Patients receiving stable dose of ACE inhibitor or Angiotensin receptor blockers for at least one month.
- Patients not currently hypertensive more than 180/110 mmHg by clinic blood pressure.
- Hemoglobulin A1C 10 mg/dL
- Phosphorus>6 mg/dL
- Patients with anticipated need of dialysis in the next 6 weeks
- Patients unstable in the opinion of the investigator
- Patients who have emergent need for starting IV iron
- Patients who will be started on statins within the next 6 weeks
- Patients currently taking PDE5 inhibitors
- Patients allergic to radiocontrast, Zemplar or who can not take nitroglycerin
- Patients known to be HIV positive
- Patients who can not give informed consent
Data sourced from ClinicalTrials.gov (NCT00428246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.