VITAL Study-Selective VITamin D Receptor Activator (Paricalcitol) for Albuminuria Lowering Study: A Phase 2, Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Subjects who are Currently Being Treated with Renin-angiotensin Sytem Inhibitors - Not available

Abbott GmbH & Co KG0 sites258 target enrollmentJune 5, 2007

Overview

No summary available.

Registry

who.int

Start Date

June 5, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Abbott GmbH & Co KG

•1\. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
•2\. Male or female subjects equal to or greater than 20 years old.
•3\. Subject has Type 2 Diabetes Mellitus and has been treated with at least one anti\-hyperglycemic medication within the 12 months prior to the Screening Phase.
•4\. Subject has been receiving a stable dose (i.e., same type and regimen) of ACEi and/or ARB for at least three months prior to the Screening Phase. However, subject may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase.
•5\. Subject is not expected to begin dialysis for at least six months.
•6\. If female, subject is not breast feeding or is not pregnant ; or is not of childbearing potential; or is of childbearing potential and practicing a method of birth control.
•7\. For entry into the Treatment Phase the subject must satisfy the following criteria based on the Screening laboratory values:
•a. Estimated GFR between 25\-75 mL/min/1\.73m2 by simplified MDRD formula.
•b. UACR between 200 and 1800 mg/g as determined by the mean of the three spot morning urine specimens obtained within one week of each other.
•c. Corrected serum calcium level equal to or less than 9\.5 mg/dL.

•1\. Subject has previously been on prescription\-based vitamin D therapy within the six months prior to the Screening Phase.
•2\. Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
•3\. Subject has primary glomerulopephritis or secondary nephritis in addition to diabetic nephropathy.
•4\. Subject has had acute renal failure within 12 weeks of the Screening Phase defined by an acute rise in serum creatinine (of at least 0\.5 mg/dL or 44 mmol/L) to more than 4 mg/dL (350 mmol/L).
•5\. Subject has chronic gastrointestinal disease, which in the Investigator's opinion may cause significant GI malabsorption.
•6\. Subject has secondary hypertension (i.e., renal artery stenosis, primary aldosteronism or pheochromocytoma).
•7\. Subject has poorly controlled hypertension (systolic blood pressure equal to or greater than 160 mmHg and or diastolic blood pressure equal to or greater than 100 mmHg).
•8\. Subject has a history of kidney stones.
•9\. Subject has a history of drug or alcohol abuse within six months prior to the Screening Phase.
•10\. Subject has evidence of poor compliance with diet or medication that may interfere, in the Investigator's opinion, with adherence to the protocol.