Clinical trial NCT01939977: Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.
Official title: Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism Due to Renal Causes
Keywords: Hyperparathyroidism
Hyperparathyroidism Secondary
Paricalcitol
Calcifediol
Parathyroid hormone
Renal transplantation
Lead sponsor: Fundación Senefro
Sponsor class: OTHER
Collaborators: name: AbbVie
name: Effice Servicios Para la Investigacion S.L.
First posted: 2013-09-11
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Percentage of Patients With iPTH Serum Concentration >110 pg/mL.
timeFrame: 6 months
Secondary outcomes:
measure: Change on iPTH Serum Concentration. Intention to Treat Analysis.
timeFrame: 6 months
measure: Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.
timeFrame: 6 months
measure: Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.
timeFrame: 6 month
measure: Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.
timeFrame: 6 months
measure: Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage.
timeFrame: 6 months
measure: Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group.
timeFrame: 6 months
measure: Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group.
timeFrame: 6 months
measure: Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation.
timeFrame: Months 1, 3 and 6
measure: Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation.
timeFrame: Months 1, 3 and 6
measure: Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation.
timeFrame: 6 months.
measure: Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation.
timeFrame: 6 months
measure: Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation.
timeFrame: 6 months
measure: Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.
timeFrame: 6 months
measure: Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group.
timeFrame: 6 months
measure: Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group
timeFrame: 6 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol de Badalona
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Fundació Puigvert-Iuna
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Cádiz
country: Spain
facility: Hospital Puerta Del Mar
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: La Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario de Canarias
city: Madrid
country: Spain
facility: Hospital Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Málaga
country: Spain
facility: Complejo Hospitalario Regional de Málaga
city: Sevilla
country: Spain
facility: Hospital Virgen Del Rocío
city: Valencia
country: Spain
facility: Hospital Universitari I Politècnic La Fe
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Fundación SENEFRO - Hospital Universitario de Bellvitge - Barcelona.
name: Josep M Cruzado, Dr
role: PRINCIPAL_INVESTIGATOR
References: