Overview

Oral Paricalcitol in Kidney Transplant Recipients

Status:
Completed
Trial end date:
2011-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study is being done to find out whether patients who receive a kidney transplant can benefit from taking the medication paricalcitol (trade name Zemplar®) as compared to kidney transplant recipients not taking this medication. The main possible benefits being studied are: - Lower risk for overactive parathyroid glands after kidney transplantation. - Lower risk of low bone density in the spine and hip after kidney transplantation. By dividing patients in the study into a group receiving Zemplar® and a group not receiving Zemplar®, it will be possible to understand the good and bad effects of Zemplar® during the first year after a kidney transplant.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
Abbott
Treatments:
Alemtuzumab
Ergocalciferols
Immunosuppressive Agents
Methylprednisolone
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus
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