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

NCT ID: NCT01939977

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Secondary Hyperparathyroidism Due to Renal Causes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paricalcitol

Paricalcitol oral capsules.

Group Type: EXPERIMENTAL

Paricalcitol

Intervention Type: DRUG

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.

Calcifediol

Calcifediol oral drops.

Group Type: ACTIVE_COMPARATOR

Calcifediol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Zemplar; Hidroferol

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Effice Servicios Para la Investigacion S.L.

INDUSTRY

Sponsor Role: collaborator

Fundación Senefro

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josep M Cruzado, Dr

Role: PRINCIPAL_INVESTIGATOR

Fundación SENEFRO - Hospital Universitario de Bellvitge - Barcelona.

Locations

Hospital Universitari Germans Trias I Pujol de Badalona

Badalona, Barcelona, Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

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

Hospital Ramón Y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Complejo Hospitalario Regional de Málaga

Málaga, , Spain

Hospital Virgen Del Rocío

Seville, , Spain

Hospital Universitari I Politècnic La Fe

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

Other Identifiers

2013-001326-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACA-SPAI-11-24

Identifier Type: -

Identifier Source: org_study_id