Secondary hyperparathyroidism after renal transplantation MedDRA version: 16.0 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Zemplar
Product Name: Zemplar
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: PARICALCITOL
CAS Number: 131918-61-1
Other descriptive name: PARICALCITOL
Concentration unit: µg micro
Sponsors
Fundación SENEFRO
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1.Reduction of aloinmune response of the receptor 2.Effects on the renal function and proteinuria parameters 3.Effects on blood pressure and speed of pulse wave 4.Effects on bone health (mineral density) 5.Frequency of related adverse events in each treatment group. 6.Subclinical rejection (cellular and humoral), chronic damage and presence of calcification on protocol biopsy on each treatment group. 7.Variation on specific markers of bone remodeling and bone mineral metabolism in each treatment group. 8.Presence of anti-HLA antibodies (preformed antibodies, PRA) in each treatment group. 9.Detection of aloreactive T memory cells against donor?s antigens in each treatment group.;Main Objective: To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.;Primary end point(s): Percentage of patients with iPTH serum concentration >110 pg/mL 6 month post-transplantation after starting treatment study o the 7 first days post-transplantation.;Timepoint(s) of evaluation of this end point: 6 month post-transplantation after starting treatment study o the 7 first days post-transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Changes on iPTH serum concentration 6 month post-transplantation and treatment in each group of treatment. 2-Percentage of patients with at least a reduction of iPTH >=30% from basal level throughout the study. 3-Percentage of patients that reach at least 30% reduction of iPTH at the end of the study. 4-Percentage of patients with iPTH levels between 70-110 pg at the end of the study. 5-Percentage of patients with calcifications o the renal biopsies 6 months after treatment in each study group. 6-Compared and separated incidence of each of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage. 7-Presence of aloreactive T memory cells against donor?s antigen at 6 months post-transplantation and treatment in each study group. 8-Change on concentration of bone markers (alkaline phosphatase and osteocalcina) and FGF-23 at 6 months post-transplantation and treatment in each study group. 9-Percentage of patients with acute rejection at 6 months post-transplantation and treatment in each study group. 10-Percentage of patients with delayed graft function rejection at 6 months post-transplantation and treatment in each study group. 11-Percentage of patients with microalbuminuria at 1, 3 and 6 months post-transplantation. 12-Percentage of patients on each stage of renal function at 1,3 and 6 months post-transplantation. 13-Evolution of blood pressure, of the speed of pulse wave, calcium-phosphorus metabolic parameters throughout the study and evolution of bone mineral density at 6 months post-transplantation. 14-Percentage of patients with hypercalcemia (defined as serum calcium levels >10,3 mg/dl) in each study group at month 6 post-transplantation.. 15-Evolution of anti-HLA antibodies (PRA) from basal to month 6 post-transplantation. 16-Safety follow up recording any adverse event or serious adverse event that occurs during the study on each treatment group.;Timepoint(s) of ev | — |
Countries
Spain
Contacts
Public ContactJosep M Cruzado
Hospital Universitari de Bellvitge
Outcome results
None listed