Overview

This trial is active, not recruiting.

Condition secondary hyperparathyroidism due to renal causes
Treatments paricalcitol, calcifediol
Phase phase 4
Sponsor Fundación Senefro
Collaborator AbbVie
Start date January 2014
End date September 2015
Trial size 180 participants
Trial identifier NCT01939977, 2013-001326-25, ACA-SPAI-11-24

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Paricalcitol oral capsules.
paricalcitol Zemplar
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.
(Active Comparator)
Calcifediol oral drops.
calcifediol Hidroferol
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.

Primary Outcomes

Measure
Percentage of patients with iPTH serum concentration >110 pg/mL.
time frame: 6 months

Secondary Outcomes

Measure
Change on iPTH serum concentration
time frame: 6 months
Percentage of patients with at least iPTH≥30% of reduction from basal level.
time frame: 1, 3 and 6 months
Percentage of patients that reach at least a 30% iPTH reduction at the end of the study.
time frame: 6 months
Percentage of patients with iPTH levels between 70-110 pg/mL at the end of the study.
time frame: 6 month
Percentage of patient with presence of calcifications on protocol renal biopsies at 6 months after treatment en each treatment group.
time frame: 6 months
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
Presence of alloreactive T memory cells against donor's antigen at 6 months after treatment en each treatment group.
time frame: 6 months
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
Percentage of patients with acute rejection at 6 months after transplantation and treatment on each treatment group.
time frame: 6 months
Percentage of patients with delayed graft function at 6 months after treatment en each treatment group.
time frame: 6 months
Percentage of patients with microalbuminuria on months 1, 3 and 6 post transplantation.
time frame: Months 1, 3 and 6
Percentage of patients on each stage of renal function on months 1, 3 and 6 post transplantation.
time frame: Months 1, 3 and 6
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.
Percentage of patients with hypercalcemia on each treatment group at 6 months post transplantation.
time frame: 6 months
Evolution of anti-HLA antibodies (PRA) from basal to month 6 post-transplantation.
time frame: 6 months
Frequency of adverse events or serious adverse events that occurs during the study on each treatment group.
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 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

Additional Information

Official title Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation.
Principal investigator Josep M Cruzado, Dr
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Fundación Senefro.