At a glance
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Oral Paricalcitol in Kidney Transplant Recipients Receiving a Corticosteroid-free Immunosuppressive Regimen
In Brief
A clinical study evaluating Paricalcitol and Corticosteroid Avoidance Immune Suppression Protocol for Transplant; Failure, Kidney and 2 related conditions. Completed, enrolled 100 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Zemplar® - this medicine, which is the medicine being studied, will be given as a capsule containing 1 microgram of Zemplar® once daily beginning the day after the transplant. It will be continued at the same dose for the first two weeks then, depending on the results of blood and urine testing, will be increased to 2 micrograms daily. The dose will remain at 2 micrograms daily until the end of the study unless there is a medical reason to reduce or stop it or unless the study is stopped early.
Induction with Alemtuzumab and maintenance with Tacrolimus and Mycophenolate Mofetil. With standard antimicrobial prophylaxis and calcium supplementation.