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 System Inhibitors - Vital

• Conditions: Type 2 diabetic nephropathy; MedDRA version: 14.1Level: PTClassification code 10038444Term: Renal failure chronicSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2006-001363-31-IT
• Lead Sponsor: Abbott GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-23
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

A subject will be selected for study participation if he/she meets the following criteria:
1.Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
2.Male or female subjects ³ 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 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 6 months.
6.If female, subject is not breast feeding or is not pregnant (verified by negative urine pregnancy test prior to the Treatment Phase); or is not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or is of childbearing potential and practicing one of the following methods of birth control:·Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)·Contraceptives (oral or parenteral) for three months prior to study drug administration·Maintains a monogamous relationship with a vasectomized partner·Total abstinence from sexual intercourse
7.For entry in the Treatment Phase the subject must satisfy the following criteria based on the Screening laboratory values:·Estimated GFR between 25-75 mL/min/1.73m2 by simplified MDRD formula·UACR between 200 and 1800 mg/g as determined by the mean of the three first morning void urine specimens obtained within one week·Corrected serum calcium level £ 9.5 mg/dL·iPTH value between 50-500 pg/mL·HbA1c £ 1 Serum albumin > 3.0 g/dL·Negative urine pregnancy test for female subjects
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting the following criteria will be excluded from the study:
1.Subject has been on prescription-based vitamin D therapy within the 6 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 glomerulonephritis 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 ³ 160 mmHg and or diastolic blood pressure ³ 100 mmHg).
8.Subject has a history of kidney stones.
9.Subject has a history of drug or alcohol abuse within 6 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.
11.Subject has received any investigational drug within 30 days prior to study drug administration. 12.Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical glucocorticoids), or other drugs that may affect calcium or bone metabolism, other than calcium containing phosphate binder or female subjects on stable (same dose and product for 3 months) estrogen and/or progestin therapy.
13.For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.
14.Subject is known to be HIV positive.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study objective is to evaluate the safety and efficacy of paricalcitol capsules on albuminuria reduction in Chronic Kidney Disease (CKD) subjects with Type 2 diabetic nephropathy receiving optimal ACEi and/or ARB therapy.;Secondary Objective: NA;Primary end point(s): The primary efficacy endpoint will be the percent change from baseline to the last on-treatment UACR measurement using UACR levels determined from the first morning void urine collections