Oral Paricalcitol in Kidney Transplant Recipients
Transplant; Failure, Kidney, Renal Disease, End Stage, Hyperparathyroidism, Secondary
About this trial
This is an interventional treatment trial for Transplant; Failure, Kidney focused on measuring Paricalcitol, Parathyroid Hormone, Bone Alkaline Phosphatase, Chronic Kidney Disease, Glomerular Filtration Rate, Vitamin D Receptor, Interstitial Fibrosis and Tubular Atrophy, Zemplar®
Eligibility Criteria
Inclusion Criteria:
- Age 18 years and older.
- First or second deceased donor or living donor renal transplant.
- Normocalcemia or hypocalcemia.
- Willing to give informed consent
Exclusion Criteria:
- Third or subsequent renal transplant.
- Incompatible blood type or positive cross-match donor.
- Multiple organ transplant recipients.
- Diabetic with plans for future pancreas or islet transplant.
- Evidence of donor-specific sensitization (positive T-cell and/or B-cell flow cytometric cross-match).
- Documented hypercalcemia (total serum calcium 10.5 mg/dl on two separate occasions) prior to transplantation.
- Serum 25(OH)vitamin D concentration ≤ 10 ng/ml
Sites / Locations
- Mayo Clinic
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Other
Active Comparator
Immunosuppression without paricalcitol (control)
Immunosuppression with paricalcitol
Subjects will receive the standard immunosuppressive therapies consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
Subjects will receive the standard immunosuppressive therapy consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®). In addition, subjects will receive the study medication paricalcitol (Zemplar®).