Phase 4
N=94
Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.
Secondary Hyperparathyroidism Due to Renal Causes
Bottom Line
View on ClinicalTrials.gov: NCT01939977 ↗Enrolled (actual)
94
Serious AEs
47.3%
Results posted
Nov 2018
Primary outcome: Primary: Percentage of Patients With iPTH Serum Concentration >110 pg/mL. — 9; 16; 32; 27 Participants — p=0.0083
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paricalcitol (Drug); Calcifediol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación Senefro
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With iPTH Serum Concentration >110 pg/mL. |
9; 16; 32; 27; 5; 4 | 0.0083 sig |
| SECONDARY Change on iPTH Serum Concentration. Intention to Treat Analysis. |
75.63; 101.27; 338.48; 315.47 | — |
| SECONDARY Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. |
39; 38; 2; 5; 5; 4 | — |
| SECONDARY Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. |
26; 16; 6; 11; 9; 16 | — |
| SECONDARY Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group. |
1; 0; 16; 19 | — |
| SECONDARY Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage. |
14; 6; 12; 15; 20; 26 | — |
| SECONDARY Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group. |
11.74; 12.62; 4.02; 5.20 | — |
| SECONDARY Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group. |
5; 2; 41; 45 | — |
| SECONDARY Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. |
18; 16; 3; 1; 25; 30 | — |
| SECONDARY Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. |
1; 4; 5; 5; 29; 27 | — |
| SECONDARY Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. |
1; 1; 14; 12; 2; 1 | — |
| SECONDARY Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. |
3; 2; 39; 41; 4; 4 | — |
| SECONDARY Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. |
1; 0; 3; 4; 1; 1 | — |
| SECONDARY Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. |
41; 38; 2; 1; 24; 20 | — |
| SECONDARY Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group. |
13.85; 14.50; 11.68; 11.79 | — |
| SECONDARY Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group |
2039.13; 1359.56; 1937.30; 289.14 | — |
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.
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 55 mg2/dL2 or in case of hyperphosphatemia considered significant as per investigator criteria
Data sourced from ClinicalTrials.gov (NCT01939977). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.