VARIATION OF PARATHYROID GLAND FOLLOWING CINACALCET USE IN DIALISYS PATIENTS WITH SONOGRAPHIC EVIDENCE OF SECONDARY HYPERPLASIA - ND

Conditions: secondary hyperparathyroidism
MedDRA version: 9.1Level: LLTClassification code 10020708

Registration Number: EUCTR2009-015723-90-IT

Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1) Patients on MHD or PD; 2) patients with SHPT defined as iPTH >300 pg/ml; 3) patients with sonographic evidence of glandular hyperplasia. The parathyroid gland will be classified as hyperplastic if the cranio-caudal, antero-posterior and latero-lateral diameters will be all major than 5 mm or the geometrical volume will be > 65 mm3 and if the gland will show a diffused hypoechoic aspect. 4) Patients never treated with Cinacalcet.
Are the trial subjects under 18? no
Number of subjects for this age range:
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

1. Pregnancy or nursing; 2. use of inhibitors of cytochrome P450 (CYP)3A4 (e.g., ketoconazole, itraconazole, erythromycin) or inducers of CYP3A4 (e.g., rifampin) within 21 d of study start, use of medications that are metabolized predominantly by CYP2D6 (e.g., flecainide, vinblastine, thioridazine,most tricyclic antidepressants) within 21 d of study start; 3. myocardial infarction within 3 months; 4. parathyroidectomy; 5. any unstable medical condition. Those patients with iPTH >300 pg/dl without ultrasonographic and scintigraphic evidence of parathyroid hyperplasia will be followed-up with US-CDI, and if they will develop morphologic sHPT, they will be enrolled in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of cinacalcet on gland volume;Secondary Objective: To evaluate: 1. the morphological changes of parathyroid glands; 2. the changes in vascular patterns of the parathyroid glands; 3. the changes in clinical score of symptoms correlated with sHPT; 4. the effects on iPTH, Calcium, Phosphorus serum levels, and Ca X P product; 5.the efficacy assessment.;Primary end point(s): The gland volume will be measured using the irregular ellipsoid formula (4/3 π x ? Postero-Anterior diameter x ? Latero-Lateral diameterx ? Cranio-Caudal diameter). We will consider the percentage of gland volume changes between the baseline and after 24-months of cinacalcet treatment. The volume will also be measured every six months (baseline, after 6 months, after 12 months, after 18 months and after 24 months).

Secondary Outcome Measures