A Randomized Study to Evaluate the Effects of Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease (CKD) Receiving Hemodialysis - ADVANCE

Conditions: Secondary hyperparathyroidism (HPT) in subjects with CKD receiving hemodialysis
MedDRA version: 14.1Level: PTClassification code 10038444Term: Renal failure chronicSystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2006-002662-19-IT

Lead Sponsor: AMGEN S.P.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

? Adults >= 18 years on hemodialysis for >= 6 months before study day 1 ? Intact PTH >300 pg/ml (bio-intact PTH > 160 pg/ml or 31.8 pmol/L) OR, ? intact PTH >= 150 pg/ml and <= 300 pg/ml (15.9-31.8 pmol/L); or biPTH 80-160 pg/ml (8.5-17.0 pmol/L) and subject is receiving active vitamin D therapy at time of PTH assessment, o and corrected serum Ca x P > 50 mg2/dl2 (3.9 mmoL2/L2) ? corrected serum calcium >= 8.4 mg/dl (2.1 mmol/L) ? Screening CAC score >= 30
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

? Current or previous use of bisphosphonates at any time ? Received non-calcium containing phosphate binders (sevelamer HCl, aluminum-containing phosphate binders, or lanthanum chloride) within 30 days prior to screening ? Received cinacalcet within 30 days prior to screening ? Started or required a change in HMG CoA reductase inhibitor dose (or other cholesterollowering medications) within 30 days before screening ? Active atrial fibrillation, history of coronary artery bypass grafting (CABG), history of coronary artery stents, aortic/cardiac valve replacement, aortic aneurysm

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Percent change from baseline in CAC score at week 52;Main Objective: To evaluate: Attenuation of the progression of coronary artery calcification (CAC) in hemodialysis subjects receiving a treatment regimen including cinacalcet and low dose of Vitamin D.;Secondary Objective: To evaluate: Attenuation of the progression of aortic calcification and aortic valve calcification. Proportion of subjects achieving > 15% progression of CAC. Absolute and percent changes in PTH, corrected calcium,phosphorus and Ca x P. Safety and tolerability of cinacalcet.

Secondary Outcome Measures