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.
The purpose of this study is 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
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.
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Percentage of Patients With iPTH Serum Concentration >110 pg/mL.
Percentage of patients with iPTH serum concentration \>110 pg/mL 6 month after transplant.
Time frame: 6 months
Change on iPTH Serum Concentration. Intention to Treat Analysis.
Change on iPTH serum concentration on each treatment group 6 month post transplantation.
Time frame: 6 months
Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.
Time frame: 6 months
Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.
Time frame: 6 month
Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.
Time frame: 6 months
Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage.
Patients with at least one of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage.
Time frame: 6 months
Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group.
Time frame: 6 months
Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group.
Time frame: 6 months
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Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, Spain
Hospital Del Mar
Barcelona, Spain
Fundació Puigvert-Iuna
Barcelona, Spain
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Hospital Puerta Del Mar
Cadiz, Spain
Hospital Reina Sofía
Córdoba, Spain
Complejo Hospitalario Universitario de Canarias
Las Palmas de Gran Canaria, Spain
...and 6 more locations
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation.
Time frame: Months 1, 3 and 6
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation.
Time frame: Months 1, 3 and 6
Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation.
Baseline speed of pulse wave was performed between 1 week and 1 month post transplant; next measure of speed of pulse wave performed at month 6 post transplant.
Time frame: 6 months.
Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation.
Percentage of patients with hypercalcemia (defined as serum calcium levels \> 10,3 mg/dl) on each treatment group at 6 months post transplantation.
Time frame: 6 months
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation.
HLAs corresponding to MHC (major histocompatibility complex) class I (A, B, and C) present peptides from inside the cell. HLAs corresponding to MHC class II (DP, DM, DO, DQ, and DR) present antigens from outside of the cell to T-lymphocytes.
Time frame: 6 months
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.
Time frame: 6 months
Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group.
Time frame: 6 months
Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group
Time frame: 6 months