Trial Outcomes & Findings for Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation. (NCT NCT01939977)

NCT ID: NCT01939977

Last Updated: 2018-11-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 148 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-11-19

Participant Flow

94 patients were randomized, but a total of 148 patients were recruited from January 2014 to February 2015.

54 of 148 patients were excluded: 48 due to Screening failure and 6 for other reasons.

Participant milestones

Measure	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.	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.
Overall Study STARTED	46	48
Overall Study COMPLETED	37	41
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Measure	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.	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.
Overall Study Adverse Event	4	3
Overall Study Lack of Efficacy	3	0
Overall Study Physician Decision	1	1
Overall Study Withdrawal by Subject	0	2
Overall Study Did not meet inclusion criteria	1	0
Overall Study Did not receive study medication	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.	Total n=93 Participants Total of all reporting groups
Age, Continuous	58.93 years STANDARD_DEVIATION 13.05 • n=5 Participants	56.15 years STANDARD_DEVIATION 14.48 • n=7 Participants	57.53 years STANDARD_DEVIATION 13.79 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Percentage of Patients With iPTH Serum Concentration >110 pg/mL. iPTH>110 pg/ml	9 Participants	16 Participants
Percentage of Patients With iPTH Serum Concentration >110 pg/mL. iPTH<=110 pg/ml	32 Participants	27 Participants
Percentage of Patients With iPTH Serum Concentration >110 pg/mL. N missing	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Measure	Paricalcitol n=41 Participants 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.	Calcifediol n=43 Participants 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.
Change on iPTH Serum Concentration. Intention to Treat Analysis. iPTH at month 6	75.63 iPTH pg/ml Standard Deviation 55.5	101.27 iPTH pg/ml Standard Deviation 55.1
Change on iPTH Serum Concentration. Intention to Treat Analysis. iPTH at baseline	338.48 iPTH pg/ml Standard Deviation 135.3	315.47 iPTH pg/ml Standard Deviation 117.7

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. Reduction iPTH>=30%	39 Participants	38 Participants
Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. Reduction iPTH<30%	2 Participants	5 Participants
Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. N missing	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 month

Outcome measures

Measure	Paricalcitol n=41 Participants 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.	Calcifediol n=43 Participants 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.
Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. iPTH<70 pg/ml	26 Participants	16 Participants
Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. iPTH 70-110 pg/ml	6 Participants	11 Participants
Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. iPTH >110 pg/ml	9 Participants	16 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Paricalcitol n=17 Participants 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.	Calcifediol n=19 Participants 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.
Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group. No calcifications	16 Participants	19 Participants
Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group. Calcifications	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Patients with at least one of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage.

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
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 event	14 Participants	6 Participants
Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage. Patients with no events	12 Participants	15 Participants
Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage. N missing	20 Participants	26 Participants

SECONDARY outcome

Timeframe: 6 months

Population: This value was missing for some patients at month 6

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group. Baseline Osteocalcin	11.74 Osteocalcin ng/ml Standard Deviation 9.2	12.62 Osteocalcin ng/ml Standard Deviation 8.5
Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group. Month 6 Osteocalcin	4.02 Osteocalcin ng/ml Standard Deviation 3.6	5.20 Osteocalcin ng/ml Standard Deviation 4.1

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group. Yes	5 Participants	2 Participants
Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group. No	41 Participants	45 Participants

SECONDARY outcome

Timeframe: Months 1, 3 and 6

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. Microalbuminuria month 1 · Normal (UACR<30 mg/g)	18 Participants	16 Participants
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. Microalbuminuria month 1 · UACR 30-300 mg/g	3 Participants	1 Participants
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. Microalbuminuria month 1 · N missing	25 Participants	30 Participants
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. Microalbuminuria month 3 · Normal (UACR<30 mg/g)	13 Participants	12 Participants
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. Microalbuminuria month 3 · UACR 30-300 mg/g	3 Participants	0 Participants
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. Microalbuminuria month 3 · N missing	30 Participants	35 Participants
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. MIcroalbuminuria month 6 · Normal (UACR<30 mg/g)	16 Participants	14 Participants
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. MIcroalbuminuria month 6 · UACR 30-300 mg/g	1 Participants	0 Participants
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. MIcroalbuminuria month 6 · N missing	29 Participants	33 Participants

SECONDARY outcome

Timeframe: Months 1, 3 and 6

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 6 · eGFR<15	2 Participants	1 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 1 · eGFR >=90	1 Participants	4 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 1 · eGFR 60-89	5 Participants	5 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 1 · eGFR 30-59	29 Participants	27 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 1 · eGFR 15-29	6 Participants	9 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 1 · eGFR<15	3 Participants	1 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 1 · N missing	2 Participants	1 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 3 · eGFR >=90	2 Participants	2 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 3 · eGFR 60-89	2 Participants	10 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 3 · eGFR 30-59	26 Participants	25 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 3 · eGFR 15-29	8 Participants	8 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 3 · eGFR<15	2 Participants	0 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 3 · N missing	6 Participants	2 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 6 · eGFR >=90	1 Participants	3 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 6 · eGFR 60-89	5 Participants	9 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 6 · eGFR 30-59	24 Participants	25 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 6 · eGFR 15-29	9 Participants	5 Participants
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. Renal function at month 6 · N missing	5 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months.

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.

Outcome measures

Measure	Paricalcitol n=17 Participants 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.	Calcifediol n=14 Participants 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.
Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. Speed pulse wave gets better at month 6	1 Participants	1 Participants
Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. Speed pulse wave maintained	14 Participants	12 Participants
Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. Speed pulse wave gets worse at month 6	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Percentage of patients with hypercalcemia (defined as serum calcium levels > 10,3 mg/dl) on each treatment group at 6 months post transplantation.

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. Serum Ca >10,3 mg/dl	3 Participants	2 Participants
Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. Serum Ca <=10,3 mg/dl	39 Participants	41 Participants
Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. N missing	4 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Paricalcitol n=40 Participants 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.	Calcifediol n=42 Participants 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.
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. Screening Luminex at transplant · Positive class I	1 Participants	0 Participants
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. Screening Luminex at transplant · Positive class II	3 Participants	4 Participants
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. Screening Luminex at transplant · Positive class I and II	1 Participants	1 Participants
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. Screening Luminex at transplant · Negative	35 Participants	37 Participants
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. Screening Luminex at month 6 · Positive class I	1 Participants	0 Participants
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. Screening Luminex at month 6 · Positive class II	6 Participants	3 Participants
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. Screening Luminex at month 6 · Positive class I and II	1 Participants	1 Participants
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. Screening Luminex at month 6 · Negative	32 Participants	38 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. Patients with adverse event (AE)	41 Participants	38 Participants
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. Patients with possibly or probably related AE	2 Participants	1 Participants
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. Patients with serious adverse event (SAE)	24 Participants	20 Participants
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. Patients with possibly or probably related SAE	0 Participants	0 Participants
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. Patients with AE that leads to discontinuation	2 Participants	4 Participants
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. Patients with moderate-severe adverse event	34 Participants	28 Participants

SECONDARY outcome

Timeframe: 6 months

Population: This value was missing for some patients at month 6

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group. Baseline alkaline phosphatase	13.85 ug/L Standard Deviation 6.9	14.50 ug/L Standard Deviation 7.4
Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group. Month 6 alkaline phosphatase	11.68 ug/L Standard Deviation 9.1	11.79 ug/L Standard Deviation 5.1

SECONDARY outcome

Timeframe: 6 months

Population: This value was missing for some patients

Outcome measures

Measure	Paricalcitol n=46 Participants 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.	Calcifediol n=47 Participants 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.
Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group Baseline FGF-23	2039.13 pg/mL Standard Deviation 3559.8	1359.56 pg/mL Standard Deviation 7112.9
Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group Month 6 FGF-23	1937.30 pg/mL Standard Deviation 3738.0	289.14 pg/mL Standard Deviation 945.1

Adverse Events

Paricalcitol

Serious events: 24 serious events

Other events: 2 other events

Deaths: 0 deaths

Calcifediol

Serious events: 20 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paricalcitol n=46 participants at risk 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.	Calcifediol n=47 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Acute pulmonary edema	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Infections and infestations Infections	23.9% 11/46 • Number of events 11 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	12.8% 6/47 • Number of events 7 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Injury, poisoning and procedural complications Surgical wound	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cells carcinoma	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Surgical and medical procedures Transplantectomy	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Surgical and medical procedures Lymphocele marsupialization	2.2% 1/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Cardiac disorders Heart failure	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Skin and subcutaneous tissue disorders Skin ulcer	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Blood and lymphatic system disorders Thrombotic microangiopathy	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Blood and lymphatic system disorders Neutropenia	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Renal and urinary disorders Impaired renal function	15.2% 7/46 • Number of events 8 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	6.4% 3/47 • Number of events 3 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Immune system disorders Allograft rejection	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Nervous system disorders Depressed level of consciousness	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Nervous system disorders Metabolic encephalopathy	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Gastrointestinal disorders Diarrhea	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Gastrointestinal disorders Anal bleeding	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
General disorders Extravasation	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
General disorders Pirexia	4.3% 2/46 • Number of events 2 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Hepatobiliary disorders Cholangitis	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Hepatobiliary disorders Acute cholecystitis	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Infections and infestations Positive test for Pseudomonas	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Renal and urinary disorders Ureteral dilation	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Renal and urinary disorders Hematuria	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	4.3% 2/47 • Number of events 2 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Renal and urinary disorders Acute kidney injury	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Renal and urinary disorders Proteinuria	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Metabolism and nutrition disorders Hyperpotasemia	2.2% 1/46 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Metabolism and nutrition disorders Dehydratation	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolia	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Vascular disorders Hematoma	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Vascular disorders Lymphocele	2.2% 1/46 • Number of events 2 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.

Other adverse events

Measure	Paricalcitol n=46 participants at risk 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.	Calcifediol n=47 participants at risk 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.
Endocrine disorders Parotiditis	0.00% 0/46 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	2.1% 1/47 • Number of events 1 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.
Metabolism and nutrition disorders Hypercalcemia	4.3% 2/46 • Number of events 2 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.	0.00% 0/47 • Adverse events collected during the participation in the study (6 months). Non serious adverse events: only reported here the study medication related adverse events.

Additional Information

Dr. Josep M. Cruzado

Hospital Universitari de Bellvitge

Phone: 0034932607602

Email: jmcruzado@bellvitgehospital.cat

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place