Efficacy and safety of paricalcitol in the reduction of secondary hyperparathyroidism after kidney transplantation.

• Conditions: Secondary hyperparathyroidism after renal transplantation; MedDRA version: 16.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2013-001326-25-ES
• Lead Sponsor: Fundación SENEFRO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-10
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.-Patients that have willingly signed and dated the ICD approved by the EC before any study procedure and after they have been explained the study, they have read the ICD and have had the opportunity to make questions about it.
2.-Patients of both genders and older than 18 years candidates to an immediately renal transplantation from living or deceased donor.
3.-24 hours previous to the transplantation patient must have iPTH levels between 250 and 600 pg/mL as per central laboratory results.
4.-Patients with a preformed antibody panel <20% 24 hours before the transplantation or that are considered by the investigator of low immunological risk (PRA determination is being done on local laboratory, not central).
5.-Serum calcium (corrected by albumin) < 10 mg/dL 24 hour previous to the transplantation as per central laboratory results.
6.-Patients that are to be treated with immunosupresion based on tacrolimus, mofetil micofenolate or micofenolic acid and with steroids and that are not going to be treated with mTOR inhibitors. Tacrolimus and steroids must not be removed on the 6 month post-transplantation.
7.-Patients that are able to take oral capsules on the first week post-transplantation.
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 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.-Third or subsequent renal transplantation.
2.-Positive cross-match assay or ABO incompatibility
3.-Patients that have been or are going to be recipients of other organs other than the kidney or a double kidney transplantation.
4.-Patients with history of allergic reaction or sensibility to paricalcitol, calcifediol or similar study drugs (related with vitamin D).
5.-Patients with chronic gastrointestinal disease, that, based on investigators criteria, can cause significant gastrointestinal malabsortion.
6.-Patient with hypo or hyperthyroidism not controlled based on investigators criteria.
7.-Patient with uncontrolled hypertension based on investigators criteria.
8.-Patients that, 48 hours previous to transplantation, have been receiving calcimimetics.
9.-Patients with VIH infection of positive serology for HBV and/or HCV
10.-Patients on treatment with drugs contraindicated with paricalcitol and calcifediol (based on SMPC)
11.-Patients that are participating on other clinical trial with investigational drugs.
12.-Women of childbearing potential (defined as those whose last menstruation was <2 years ago and that are not surgically sterilized) that are not willing to use correct contraception during study treatment.
13.-Patient with other diseases or conditions that based on investigators criteria are not suitable for the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified