Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidne… (NCT01939977) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.
Spain148 participantsStarted 2014-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
Percentage of Patients With iPTH Serum Concentration >110 pg/mL.