Efficacy and Safety of Paricalcitol in the Reduction of S... | NCT01939977

ID	Type	Description	Link
2013-001326-25	EudraCT Number

Name	Class
AbbVie	INDUSTRY
Effice Servicios Para la Investigacion S.L.	INDUSTRY

Label	Type	Description	Intervention Names
Paricalcitol	Experimental	Paricalcitol oral capsules.	Drug: Paricalcitol
Calcifediol	Active Comparator	Calcifediol oral drops.	Drug: Calcifediol

Name	Type	Description	Arm Group Labels	Other Names
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.	Paricalcitol

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change on iPTH Serum Concentration. Intention to Treat Analysis.	Change on iPTH serum concentration on each treatment group 6 month post transplantation.	6 months
Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.

Eligibility Module

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

Name	Affiliation	Role
Josep M Cruzado, Dr	Fundación SENEFRO - Hospital Universitario de Bellvitge - Barcelona.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Germans Trias I Pujol de Badalona		Badalona	Barcelona	08916	Spain
Hospital Universitari de Bellvitge

ID	Title	Description
FG000	Paricalcitol	Paricalcitol oral capsules. 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.
FG001	Calcifediol

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG00046 OG00147

Title

Denominators

Categories

Title	Measurements
iPTH>110 pg/ml	OG0009 OG00116
iPTH<=110 pg/ml	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Taking "per protocol" population, the percentage of patients with iPTH> 110 pg / ml at 6 months post-transplant treated with Paricalcitol was statistically lower than in patients treated with Calcifediol	Chi-squared		0.0083														Superiority

Secondary

Change on iPTH Serum Concentration. Intention to Treat Analysis.

Change on iPTH serum concentration on each treatment group 6 month post transplantation.

Posted

Mean

Standard Deviation

iPTH pg/ml

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

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

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

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

Posted

Count of Participants

Participants

6 month

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

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

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

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.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group.

This value was missing for some patients at month 6

Posted

Mean

Standard Deviation

Osteocalcin ng/ml

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation.

Posted

Count of Participants

Participants

Months 1, 3 and 6

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation.

Posted

Count of Participants

Participants

Months 1, 3 and 6

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

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.

Posted

Count of Participants

Participants

6 months.

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

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.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

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.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group.

This value was missing for some patients at month 6

Posted

Mean

Standard Deviation

ug/L

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Secondary

Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group

This value was missing for some patients

Posted

Mean

Standard Deviation

pg/mL

6 months

ID	Title	Description
OG000	Paricalcitol	Paricalcitol oral capsules. 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.
OG001	Calcifediol	Calcifediol oral drops. 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.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Infections	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG00011 events11 affected46 at risk EG0017 events6 affected47 at risk
Surgical wound	Injury, poisoning and procedural complications	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected47 at risk
Transitional cells carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Transplantectomy	Surgical and medical procedures	MedDRA (6.1)	Systematic Assessment	EG0000 affected46 at risk EG0011 affected47 at risk
Lymphocele marsupialization	Surgical and medical procedures	MedDRA (6.1)	Systematic Assessment	EG0001 affected46 at risk EG0010 affected47 at risk
Heart failure	Cardiac disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Impaired renal function	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Allograft rejection	Immune system disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected47 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Anal bleeding	Gastrointestinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Extravasation	General disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Pirexia	General disorders	MedDRA (6.1)	Systematic Assessment	EG0002 events2 affected46 at risk EG0010 events0 affected47 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Acute cholecystitis	Hepatobiliary disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Positive test for Pseudomonas	Infections and infestations	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Impaired renal function	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0008 events7 affected46 at risk EG0013 events3 affected47 at risk
Ureteral dilation	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Hematuria	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0012 events2 affected47 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Proteinuria	Renal and urinary disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Hyperpotasemia	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Dehydratation	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0011 events1 affected47 at risk
Acute pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0001 events1 affected46 at risk EG0010 events0 affected47 at risk
Pulmonary embolia	Respiratory, thoracic and mediastinal disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Hematoma	Vascular disorders	MedDRA (6.1)	Systematic Assessment	EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Lymphocele	Vascular disorders	MedDRA (6.1)	Systematic Assessment	EG0002 events1 affected46 at risk EG0010 events0 affected47 at risk

ID	Term
D006961	Hyperparathyroidism
D006962	Hyperparathyroidism, Secondary

ID	Term
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

ID	Term
D006887	Hydroxycholecalciferols
D002762	Cholecalciferol
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013261	Sterols
D014807	Vitamin D
D012632	Secosteroids
D008563	Membrane Lipids
D008055	Lipids

ID	Title	Description
BG000	Paricalcitol	Paricalcitol oral capsules. 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.
BG001	Calcifediol	Calcifediol oral drops. 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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Paricalcitol	Paricalcitol oral capsules. 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.	0	46	24	46	2	46
EG001	Calcifediol	Calcifediol oral drops. 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.	0	47	20	47	1	47

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Parotiditis	Endocrine disorders	MedDRA (6.1)	Systematic Assessment		EG0000 events0 affected46 at risk EG0011 events1 affected47 at risk
Hypercalcemia	Metabolism and nutrition disorders	MedDRA (6.1)	Systematic Assessment		EG0002 events2 affected46 at risk EG0010 events0 affected47 at risk