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