Hiperparatiroidismo secundario post trasplante renal MedDRA version: 9.1 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary
Conditions
Interventions
Trade Name: Mimpara
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CINACALCET
CAS Number: 364782-34-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Sponsors
Josep M Cruzado
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.Functionning renal allograft, estimated GFR = 30 ml/min 2.More than 6 m after transplantation 3.PTHi =15 pmol/L 4.Calcemia =2.7 mmol/L with phosphatemia =1.2 mmol/L 5.MIBI 6.Written informed consent 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: Exclusion criteria: 1.Surgical contraindication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): percentage of patients with normocalcemia at year 1;Main Objective: To study the percentage of patients with normocalcemia at 1 year after treatment with cinacalcet versus subtotal parathyreidectomy;Secondary Objective: Percentage of patients with PTHi according guidelines, renal function, economic cost study, incidence of cardiovascular events and graft and patient survival at year 1 | — |
Countries
Spain
Outcome results
None listed