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

Secondary Hyperparathyroidism Due to Renal Causes Clinical Trial

— PARIDOINAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939977
• Other study ID #: ACA-SPAI-11-24
• Secondary ID: 2013-001326-25
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2018
• Source: Fundación Senefro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism Due to Renal Causes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias I Pujol de Badalona	Badalona	Barcelona
Spain	Fundació Puigvert-Iuna	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Puerta Del Mar	Cádiz
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Complexo Hospitalario Universitario A Coruna	La Coruna
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 Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Virgen Del Rocío	Sevilla
Spain	Hospital Universitari I Politècnic La Fe	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Senefro	AbbVie, Effice Servicios Para la Investigacion S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change on iPTH Serum Concentration. Intention to Treat Analysis.	Change on iPTH serum concentration on each treatment group 6 month post transplantation.	6 months
Secondary	Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.		6 months
Secondary	Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.		6 month
Secondary	Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.		6 months
Secondary	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.	6 months
Secondary	Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group.		6 months
Secondary	Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group.		6 months
Secondary	Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation.		Months 1, 3 and 6
Secondary	Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation.		Months 1, 3 and 6
Secondary	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.	6 months.
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.		6 months
Secondary	Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group.		6 months
Secondary	Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group		6 months