Secondary Hyperparathyroidism Due to Renal Causes
Conditions
Keywords
Hyperparathyroidism, Hyperparathyroidism Secondary, Paricalcitol, Calcifediol, Parathyroid hormone, Renal transplantation
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.
Detailed 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.
Interventions
DRUGParicalcitol
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.
DRUGCalcifediol
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.
Sponsors
AbbVie
Effice Servicios Para la Investigacion S.L.
Fundación Senefro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With iPTH Serum Concentration >110 pg/mL. | 6 months | Percentage of patients with iPTH serum concentration \>110 pg/mL 6 month after transplant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. | 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. |
| Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. | 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. |
| Change on iPTH Serum Concentration. Intention to Treat Analysis. | 6 months | Change on iPTH serum concentration on each treatment group 6 month post transplantation. |
| 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 | Patients with at least one of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage. |
| Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. | Months 1, 3 and 6 | — |
| Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group. | 6 months | — |
| Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Months 1, 3 and 6 | — |
| Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | 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. |
| Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. | 6 months | — |
| Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group. | 6 months | — |
| Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group | 6 months | — |
| Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group. | 6 months | — |
Countries
Spain
Participant flow
Recruitment details
94 patients were randomized, but a total of 148 patients were recruited from January 2014 to February 2015.
Pre-assignment details
54 of 148 patients were excluded: 48 due to Screening failure and 6 for other reasons.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| 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. | 47 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 3 |
| Overall Study | Did not meet inclusion criteria | 1 | 0 |
| Overall Study | Did not receive study medication | 0 | 1 |
| Overall Study | Lack of Efficacy | 3 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Paricalcitol | Calcifediol | Total |
|---|---|---|---|
| Age, Continuous | 58.93 years STANDARD_DEVIATION 13.05 | 56.15 years STANDARD_DEVIATION 14.48 | 57.53 years STANDARD_DEVIATION 13.79 |
| Sex: Female, Male Female | 14 Participants | 16 Participants | 30 Participants |
| Sex: Female, Male Male | 32 Participants | 31 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 47 |
| other Total, other adverse events | 2 / 46 | 1 / 47 |
| serious Total, serious adverse events | 24 / 46 | 20 / 47 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paricalcitol | Percentage of Patients With iPTH Serum Concentration >110 pg/mL. | iPTH>110 pg/ml | 9 Participants |
| Paricalcitol | Percentage of Patients With iPTH Serum Concentration >110 pg/mL. | iPTH<=110 pg/ml | 32 Participants |
| Paricalcitol | Percentage of Patients With iPTH Serum Concentration >110 pg/mL. | N missing | 5 Participants |
| Calcifediol | Percentage of Patients With iPTH Serum Concentration >110 pg/mL. | iPTH<=110 pg/ml | 27 Participants |
| Calcifediol | Percentage of Patients With iPTH Serum Concentration >110 pg/mL. | iPTH>110 pg/ml | 16 Participants |
| Calcifediol | Percentage of Patients With iPTH Serum Concentration >110 pg/mL. | N missing | 4 Participants |
Comparison: 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 Calcifediolp-value: 0.0083Chi-squared
Secondary
Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group.
Time frame: 6 months
Population: This value was missing for some patients at month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Calcifediol | Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group. | Baseline alkaline phosphatase | 14.50 ug/L | Standard Deviation 7.4 |
| Calcifediol | Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group. | Month 6 alkaline phosphatase | 11.79 ug/L | Standard Deviation 5.1 |
Secondary
Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group
Time frame: 6 months
Population: This value was missing for some patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Calcifediol | Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group | Baseline FGF-23 | 1359.56 pg/mL | Standard Deviation 7112.9 |
| Calcifediol | Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group | Month 6 FGF-23 | 289.14 pg/mL | Standard Deviation 945.1 |
Secondary
Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group.
Time frame: 6 months
Population: This value was missing for some patients at month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Calcifediol | Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group. | Baseline Osteocalcin | 12.62 Osteocalcin ng/ml | Standard Deviation 8.5 |
| Calcifediol | Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group. | Month 6 Osteocalcin | 5.20 Osteocalcin ng/ml | Standard Deviation 4.1 |
Secondary
Change on iPTH Serum Concentration. Intention to Treat Analysis.
Change on iPTH serum concentration on each treatment group 6 month post transplantation.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Change on iPTH Serum Concentration. Intention to Treat Analysis. | iPTH at month 6 | 75.63 iPTH pg/ml | Standard Deviation 55.5 |
| Paricalcitol | Change on iPTH Serum Concentration. Intention to Treat Analysis. | iPTH at baseline | 338.48 iPTH pg/ml | Standard Deviation 135.3 |
| Calcifediol | Change on iPTH Serum Concentration. Intention to Treat Analysis. | iPTH at month 6 | 101.27 iPTH pg/ml | Standard Deviation 55.1 |
| Calcifediol | Change on iPTH Serum Concentration. Intention to Treat Analysis. | iPTH at baseline | 315.47 iPTH pg/ml | Standard Deviation 117.7 |
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.
Time frame: 6 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Paricalcitol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at transplant | Negative | 35 Participants |
| Paricalcitol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at month 6 | Positive class I | 1 Participants |
| Paricalcitol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at month 6 | Positive class II | 6 Participants |
| Paricalcitol | 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 |
| Paricalcitol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at transplant | Positive class I | 1 Participants |
| Paricalcitol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at transplant | Positive class II | 3 Participants |
| Paricalcitol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at transplant | Positive class I and II | 1 Participants |
| Paricalcitol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at month 6 | Negative | 32 Participants |
| Calcifediol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at transplant | Positive class I | 0 Participants |
| Calcifediol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at transplant | Negative | 37 Participants |
| Calcifediol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at month 6 | Positive class I | 0 Participants |
| Calcifediol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at transplant | Positive class II | 4 Participants |
| Calcifediol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at month 6 | Positive class II | 3 Participants |
| Calcifediol | 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 |
| Calcifediol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at month 6 | Negative | 38 Participants |
| Calcifediol | Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. | Screening Luminex at transplant | Positive class I and II | 1 Participants |
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.
Time frame: 6 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paricalcitol | Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. | Speed pulse wave gets better at month 6 | 1 Participants |
| Paricalcitol | Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. | Speed pulse wave gets worse at month 6 | 2 Participants |
| Paricalcitol | Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. | Speed pulse wave maintained | 14 Participants |
| Calcifediol | Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. | Speed pulse wave maintained | 12 Participants |
| Calcifediol | Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. | Speed pulse wave gets worse at month 6 | 1 Participants |
| Calcifediol | Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. | Speed pulse wave gets better at month 6 | 1 Participants |
Secondary
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.
Time frame: 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paricalcitol | Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. | Patients with adverse event (AE) | 41 Participants |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Calcifediol | Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. | Patients with AE that leads to discontinuation | 4 Participants |
| Calcifediol | Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. | Patients with adverse event (AE) | 38 Participants |
| Calcifediol | 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 |
| Calcifediol | Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. | Patients with possibly or probably related AE | 1 Participants |
| Calcifediol | Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. | Patients with moderate-severe adverse event | 28 Participants |
| Calcifediol | Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. | Patients with serious adverse event (SAE) | 20 Participants |
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Calcifediol | 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 | 6 Participants |
| Calcifediol | 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 | 15 Participants |
| Calcifediol | Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage. | N missing | 26 Participants |
Secondary
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation.
Time frame: Months 1, 3 and 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Paricalcitol | 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 |
| Calcifediol | 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 | 10 Participants |
| Calcifediol | Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. | Renal function at month 6 | N missing | 4 Participants |
| Calcifediol | Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. | Renal function at month 1 | eGFR >=90 | 4 Participants |
| Calcifediol | 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 |
| Calcifediol | 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 | 27 Participants |
| Calcifediol | 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 | 9 Participants |
| Calcifediol | Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. | Renal function at month 1 | eGFR<15 | 1 Participants |
| Calcifediol | Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. | Renal function at month 1 | N missing | 1 Participants |
| Calcifediol | 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 |
| Calcifediol | Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. | Renal function at month 6 | eGFR<15 | 1 Participants |
| Calcifediol | 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 | 25 Participants |
| Calcifediol | 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 |
| Calcifediol | Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. | Renal function at month 3 | eGFR<15 | 0 Participants |
| Calcifediol | Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. | Renal function at month 3 | N missing | 2 Participants |
| Calcifediol | Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. | Renal function at month 6 | eGFR >=90 | 3 Participants |
| Calcifediol | 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 | 9 Participants |
| Calcifediol | 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 | 25 Participants |
| Calcifediol | 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 | 5 Participants |
Secondary
Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paricalcitol | Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. | N missing | 5 Participants |
| Paricalcitol | Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. | Reduction iPTH>=30% | 39 Participants |
| Paricalcitol | Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. | Reduction iPTH<30% | 2 Participants |
| Calcifediol | Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. | N missing | 4 Participants |
| Calcifediol | Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. | Reduction iPTH>=30% | 38 Participants |
| Calcifediol | Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. | Reduction iPTH<30% | 5 Participants |
Secondary
Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paricalcitol | Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group. | Yes | 5 Participants |
| Paricalcitol | Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group. | No | 41 Participants |
| Calcifediol | Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group. | No | 45 Participants |
| Calcifediol | Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group. | Yes | 2 Participants |
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paricalcitol | Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. | Serum Ca >10,3 mg/dl | 3 Participants |
| Paricalcitol | Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. | Serum Ca <=10,3 mg/dl | 39 Participants |
| Paricalcitol | Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. | N missing | 4 Participants |
| Calcifediol | Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. | Serum Ca >10,3 mg/dl | 2 Participants |
| Calcifediol | Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. | Serum Ca <=10,3 mg/dl | 41 Participants |
| Calcifediol | Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. | N missing | 4 Participants |
Secondary
Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.
Time frame: 6 month
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paricalcitol | Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. | iPTH<70 pg/ml | 26 Participants |
| Paricalcitol | 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 |
| Paricalcitol | Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. | iPTH >110 pg/ml | 9 Participants |
| Calcifediol | Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. | iPTH<70 pg/ml | 16 Participants |
| Calcifediol | Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. | iPTH 70-110 pg/ml | 11 Participants |
| Calcifediol | Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. | iPTH >110 pg/ml | 16 Participants |
Secondary
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation.
Time frame: Months 1, 3 and 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Paricalcitol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 1 | UACR 30-300 mg/g | 3 Participants |
| Paricalcitol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 3 | N missing | 30 Participants |
| Paricalcitol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 3 | Normal (UACR<30 mg/g) | 13 Participants |
| Paricalcitol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | MIcroalbuminuria month 6 | Normal (UACR<30 mg/g) | 16 Participants |
| Paricalcitol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 1 | N missing | 25 Participants |
| Paricalcitol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | MIcroalbuminuria month 6 | UACR 30-300 mg/g | 1 Participants |
| Paricalcitol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 3 | UACR 30-300 mg/g | 3 Participants |
| Paricalcitol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | MIcroalbuminuria month 6 | N missing | 29 Participants |
| Paricalcitol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 1 | Normal (UACR<30 mg/g) | 18 Participants |
| Calcifediol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | MIcroalbuminuria month 6 | N missing | 33 Participants |
| Calcifediol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 1 | Normal (UACR<30 mg/g) | 16 Participants |
| Calcifediol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 1 | UACR 30-300 mg/g | 1 Participants |
| Calcifediol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 1 | N missing | 30 Participants |
| Calcifediol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 3 | Normal (UACR<30 mg/g) | 12 Participants |
| Calcifediol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 3 | UACR 30-300 mg/g | 0 Participants |
| Calcifediol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | Microalbuminuria month 3 | N missing | 35 Participants |
| Calcifediol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | MIcroalbuminuria month 6 | Normal (UACR<30 mg/g) | 14 Participants |
| Calcifediol | Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. | MIcroalbuminuria month 6 | UACR 30-300 mg/g | 0 Participants |
Secondary
Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paricalcitol | Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group. | Calcifications | 1 Participants |
| Paricalcitol | Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group. | No calcifications | 16 Participants |
| Calcifediol | Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group. | Calcifications | 0 Participants |
| Calcifediol | Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group. | No calcifications | 19 Participants |