Previous Clinical Trials

A Phase 3, Open-label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion From Prograf® Capsules Twice Daily to LCP Tacro™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients

Purpose: This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy with LCP Tacro™ tablets (tacrolimus, LifeCycle Pharma A/S, Hoersholm, Denmark) once daily for the prevention of acute allograft rejection in stable adult kidney transplant patients. Patients on a stable dose of Prograf® will be randomly assigned to be converted from Prograf® twice daily to LCP Tacro™ once daily or to remain on maintenance therapy with Prograf® twice daily. Patients entering the study will be treated with assigned study drug and followed for one year for patient survival and the incidence of graft rejection or graft loss.

ClinicalTrials.gov ID:

NCT00817206

Sponsor:

LifeCycle Pharma A/S

Status:

Active, Not Recruiting

 

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of the Safety, Tolerability and Population Pharmacokinetics of CMX001 in Post-Transplant Subjects With BK Virus Viruria

Purpose: Renal and hematopoetic stem cell patients with BK virus viruria post-transplant will be enrolled and randomized to 5 weeks of dosing with CMX001 or placebo. Safety assessments including clinical laboratory evaluations and vital signs measurements will be performed and blood samples will be collected to measure the amount of study drug in the blood. Viral levels will be measured in the blood and urine.

ClinicalTrials.gov ID: NCT00793598

Sponsor:

Chimerix

Status:

Completed

 

 

A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo Renal Allograft Recipients

Purpose: A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.

ClinicalTrials.gov ID: NCT00483756

Sponsor:

Pfizer

Status:

Completed

 

 A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients

Purpose: A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.

ClinicalTrials.gov ID:

NCT00543569

Sponsor:

Asellas Pharma Inc.

Status:

Completed