Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.
Condition: Secondary Hyperparathyroidism Due to Renal Causes
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Paricalcitol; Calcifediol
Intervention description: 1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours.; 5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment.
Intervention MeSH terms: Calcifediol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hyperparathyroidism; Hyperparathyroidism Secondary; Paricalcitol; Calcifediol; Parathyroid hormone; Renal transplantation

Summary:

      To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation
      (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D
      nutritional supplements (calcifediol) in patients with renal transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient that have willingly signed and dated the ICD (Informed Consent Document)
             approved by the EC (Ethics Committee) 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.

          -  Patients of both genders and older than 18 years candidates to an immediately renal
             transplantation from living or deceased donor.

          -  24 hours previous to the transplantation, patient must have a significant grade of
             secondary hyperparathyroidism, defined as iPTH (Intact parathyroid hormone) levels
             between 110 and 600 pg/mL as per central laboratory results.

          -  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).

          -  Serum calcium (corrected by albumin) < 10 mg/dL 24 hour previous to the
             transplantation as per central laboratory results.

          -  Patients that are to be treated with immunosuppression based on tacrolimus, mofetil
             mycofenolate or mycophenolic acid and with steroids and that are not going to be
             treated with mTOR (mammalian target of rapamycin) inhibitors. Tacrolimus and steroids
             must not be removed on the 6 month post-transplantation.

          -  Patients that are able to take oral capsules on the first week post-transplantation.

        Exclusion Criteria:

          -  Third or subsequent renal transplantation.

          -  Positive cross-match assay or ABO (A-B-0) incompatibility

          -  Patients that have been or are going to be recipients of other organs other than the
             kidney or a double kidney transplantation.

          -  Patients with history of allergic reaction or sensibility to paricalcitol, calcifediol
             or similar study drugs (related with vitamin D).

          -  Patients with chronic gastrointestinal disease, that, based on investigators criteria,
             can cause significant gastrointestinal malabsorption.

          -  Patient with hypo or hyperthyroidism not controlled based on investigators criteria.

          -  Patient with uncontrolled hypertension based on investigators criteria.

          -  Patients that, 48 hours previous to transplantation, have been receiving
             calcimimetics.

          -  Patients with VIH (human immunodeficiency virus)infection of positive serology for HBV
             (hepatitis B virus) and/or HCV (hepatitis C virus)

          -  Patients on treatment with drugs contraindicated with paricalcitol and calcifediol
             (based on SMPC)

          -  Patients that are participating on other clinical trial with investigational drugs.

          -  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.

          -  Patient with other diseases or conditions that based on investigators criteria are not
             suitable for the study.

          -  Treatment will not be started if the Calcium-Phosphorus product (CAxP)is >55 mg2/dL2
             or in case of hyperphosphatemia considered significant as per investigator criteria