se of Calcimimetics vs oral Paricalcitol in Renal transplant Patients affected with Persistent Secondary Hyperparathyroidism. A pilot study - ND

Conditions: Renal transplant patients
MedDRA version: 9.1Level: LLTClassification code 10020708

Registration Number: EUCTR2010-021041-42-IT

Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

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)Inclusion criteria in Lead-in: Patient has received renal transplant more than 6 months before enrolment. Persistent secondary hyperparathyroidism after renal transplantation, intended as: Serum PTH higher than reference KDOQI range for the individual renal function. Serum Ca level:>10,5 mg/dL and < 12,5 mg/dL. GFR >= 15 mL/min 2)Entry criteria at baseline (after 4 weeks cinacalcet lead-in): Subjects should have a serum Ca level less than 10,2 mg/dL.
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

< 18 or > 70 years of age. Participant to other studies in the last 30 days. Acute rejection. Acute intercurrent illness. Life expectancy < 1 year for comorbid conditions. Any neoplasia. Use of Cinacalcet, Paricalcitol, biphosphonates or any form of vitamin D in the last 2 months (multivitamin supplements containing <= 400 IU of vitamin D are not restricted).Subject is currently receiving high doses (nonmaintenance therapy) of steroids ( >=10 mg/day of prednisone or equivalent)(except topical or inhaled glucocorticoids). Pregnant (confirmed by screening pregnancy test) or lactating females. Drugs intolerance. For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules and/or cinacalcet or is put at risk by study procedures.Subjects with serum Ca equal or greater than 10.2 mg/dL after the 4-week lead-in phase will be excluded from the study