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

NCT01939977 | Completed Phase 4 Results

• 2 other identifiers: ACA-SPAI-11-242013-001326-25
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 16

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.

Conditions

Secondary Hyperparathyroidism Due to Renal Causes

Keywords

Hyperparathyroidism; Hyperparathyroidism Secondary; Paricalcitol; Calcifediol; Parathyroid hormone; Renal transplantation

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With iPTH Serum Concentration >110 pg/mL.

  Percentage of patients with iPTH serum concentration \>110 pg/mL 6 month after transplant.

  6 months

Secondary Outcomes (15)

• Change on iPTH Serum Concentration. Intention to Treat Analysis.

  6 months

• Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.

  6 months

• Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.

  6 month

• Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.

  6 months

• Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage.

  6 months

Study Arms (2)

Paricalcitol

EXPERIMENTAL

Paricalcitol oral capsules.

Drug: Paricalcitol

Calcifediol

ACTIVE COMPARATOR

Calcifediol oral drops.

Drug: Calcifediol

Interventions

Paricalcitol 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.

Also known as: Zemplar

Paricalcitol

Calcifediol 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.

Also known as: Hidroferol

Calcifediol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Senefro: lead
• AbbVie: collaborator
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (16)

Hospital Universitari Germans Trias I Pujol de Badalona

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Complexo Hospitalario Universitario A Coruna

A Coruña, 15006, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Fundació Puigvert-Iuna

Barcelona, 08025, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital Reina Sofía

Córdoba, 14004, Spain

Location

Complejo Hospitalario Universitario de Canarias

Las Palmas de Gran Canaria, 38320, Spain

Location

Hospital Ramón Y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Complejo Hospitalario Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Virgen Del Rocío

Seville, 41013, Spain

Location

Hospital Universitari I Politècnic La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Hyperparathyroidism; Hyperparathyroidism, Secondary

Interventions

paricalcitol; Calcifediol

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Josep M. Cruzado
• Organization: Hospital Universitari de Bellvitge

jmcruzado@bellvitgehospital.cat

0034932607602

Study Officials

• Josep M Cruzado, Dr

  Fundación SENEFRO - Hospital Universitario de Bellvitge - Barcelona.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 11, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 19, 2018
• Results First Posted: November 19, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (16)