secondary hyperparathyroidism MedDRA version: 9.1 Level: LLT Classification code 10020708
Conditions
Interventions
Trade Name: MIMPARA*28CPR RIV 30MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Cinacalcet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Trade Nam
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Italy
Outcome results
None listed