Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation. (PARIDOINAL2013)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Fundación Senefro
Sponsor:
Collaborators:
AbbVie
Effice Servicios Para la Investigacion S.L.
Information provided by (Responsible Party):
Fundación Senefro
ClinicalTrials.gov Identifier:
NCT01939977
First received: August 28, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Secondary Hyperparathyroidism Due to Renal Causes
Drug: Paricalcitol
Drug: Calcifediol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation.

Resource links provided by NLM:


Further study details as provided by Fundación Senefro:

Primary Outcome Measures:
  • Percentage of patients with iPTH serum concentration >110 pg/mL. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percentage of patients with iPTH serum concentration >110 pg/mL post transplantation and 6 month after treatment.


Secondary Outcome Measures:
  • Change on iPTH serum concentration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Change on iPTH serum concentration on each treatment group 6 month post transplantation and treatment.

  • Percentage of patients with at least iPTH≥30% of reduction from basal level. [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients that reach at least a 30% iPTH reduction at the end of the study. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with iPTH levels between 70-110 pg/mL at the end of the study. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Percentage of patient with presence of calcifications on protocol renal biopsies at 6 months after treatment en each treatment group. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Incidence, compared and separate, of each of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Presence of alloreactive T memory cells against donor's antigen at 6 months after treatment en each treatment group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change on concentration of bone markers (alkaline phosphatase and osteocalcin) and FGF-23 (Fibroblast growth factor 23) at 6 months after transplantation and treatment on each treatment group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with acute rejection at 6 months after transplantation and treatment on each treatment group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with delayed graft function at 6 months after treatment en each treatment group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with microalbuminuria on months 1, 3 and 6 post transplantation. [ Time Frame: Months 1, 3 and 6 ] [ Designated as safety issue: No ]
  • Percentage of patients on each stage of renal function on months 1, 3 and 6 post transplantation. [ Time Frame: Months 1, 3 and 6 ] [ Designated as safety issue: No ]
  • Evolution of blood pressure, speed of pulse wave, calcium-phosphorus metabolic parameters throughout the study and evolution of bone mineral density at 6 post transplantation. [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
  • Percentage of patients with hypercalcemia on each treatment group at 6 months post transplantation. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Percentage of patients with hypercalcemia (defined as serum calcium levels > 10,3 mg/dl) on each treatment group at 6 months post transplantation.

  • Evolution of anti-HLA antibodies (PRA) from basal to month 6 post-transplantation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency of adverse events or serious adverse events that occurs during the study on each treatment group. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: January 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paricalcitol
Paricalcitol oral capsules.
Drug: Paricalcitol
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.
Other Name: Zemplar
Active Comparator: Calcifediol
Calcifediol oral drops.
Drug: Calcifediol
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.
Other Name: Hidroferol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 levels between 250 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939977

Contacts
Contact: Josep M Cruzado, Dr +34 93 260 76 02 jmcruzado@bellvitgehospital.cat
Contact: Nieves Collantes +34 902 92 92 10 senefro.nieves@senefro.org

Locations
Spain
Hospital Universitari Germans Trias I Pujol de Badalona Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Ricardo Lauzurica, Dr       rlauzurica.germanstrias@gencat.cat   
Principal Investigator: Ricardo Lauzurica, Dr         
Hospital Universitari de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Josep M Cruzado, Dr    +34 93 2607602    jmcruzado@bellvitgehospital.cat   
Principal Investigator: Josep M Cruzado, Dr         
Hospital Universitario Marqués de Valdecilla Not yet recruiting
Santander, Cantabria, Spain, 39008
Contact: Juan Carlos Ruiz Sanmillán, Dr    +34 94 202520    ruizjc@humv.es   
Principal Investigator: Juan Carlos Ruiz Sanmillán, Dr         
Complejo Hospitalario Universitario de Canarias Recruiting
San Cristobal de La Laguna, Las Palmas de Gran Canaria, Spain, 38320
Contact: Armando Torres Ramírez, Dr    +34 922 678000    atorres@ull.es   
Principal Investigator: Armando Torres Ramírez, Dr         
Hospital Infanta Cristina Active, not recruiting
Badajoz, Spain, 06080
Fundació Puigvert-Iuna Active, not recruiting
Barcelona, Spain, 08025
Hospital Universitari Vall D'Hebron Active, not recruiting
Barcelona, Spain, 08035
Hospital Del Mar Active, not recruiting
Barcelona, Spain, 08003
Hospital Puerta Del Mar Active, not recruiting
Cádiz, Spain, 11009
Hospital Reina Sofía Active, not recruiting
Córdoba, Spain, 14004
Hospital Universitario Virgen de Las Nieves Active, not recruiting
Granada, Spain, 18014
Complexo Hospitalario Universitario A Coruña Active, not recruiting
La Coruña, Spain, 15006
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain, 28041
Hospital Ramón Y Cajal Active, not recruiting
Madrid, Spain, 28034
Complejo Hospitalario Regional de Málaga Recruiting
Málaga, Spain, 29010
Contact: Domingo Hernández Marrero, Dr    +34 951 290000    Domingohernandez@gmail.com   
Principal Investigator: Domingo Hernández Marrero, Dr         
Hospital Virgen Del Rocío Active, not recruiting
Sevilla, Spain, 41013
Hospital Universitari I Politècnic La Fe Active, not recruiting
Valencia, Spain, 46026
Hospital Universitario Miguel Servet Active, not recruiting
Zaragoza, Spain, 50009
Sponsors and Collaborators
Fundación Senefro
AbbVie
Effice Servicios Para la Investigacion S.L.
Investigators
Principal Investigator: Josep M Cruzado, Dr Fundación SENEFRO - Hospital Universitario de Bellvitge - Barcelona.
  More Information

No publications provided

Responsible Party: Fundación Senefro
ClinicalTrials.gov Identifier: NCT01939977     History of Changes
Other Study ID Numbers: ACA-SPAI-11-24, 2013-001326-25
Study First Received: August 28, 2013
Last Updated: May 5, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundación Senefro:
Hyperparathyroidism
Hyperparathyroidism Secondary
Paricalcitol
Calcifediol
Parathyroid hormone
Renal transplantation

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Calcifediol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 20, 2014