Previous Clinical Trials
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial – Extended Criteria Donors (BENEFIT-EXT)
| Purpose: The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria. | ClinicalTrials.gov ID: | Sponsor:
Bristol-Myers Squibb |
Status:
Active, Not Enrolling |
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (Benefit)
| Purpose: The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied. | ClinicalTrials.gov ID: | Sponsor:
Bristol-Myers Squibb |
Status:
Active, Not Enrolling |
Polyomavirus Aggregates, Haufen, in Voided Urine Samples as Diagnostic Biomarkers of Intra Renal BK-virus Disease: a Prospective Proof-of-concept Study
| Purpose: To prospectively test whether the detection of three-dimensional, cast-like polyomavirus aggregates, termed Haufen, in voided urine samples can serve as an accurate biomarker of intra-renal disease, i.e. polyoma-BK-virus nephropathy (PVN). We want to correlate the detection of ‘Haufen’ with histologic findings made in renal biopsies as well as signs of polyomavirus activation, i.e. viremia and viruria. The prospective study is designed to further validate our retrospective findings (manuscript in press, J Am Soc Nephrol) and more specifically to correlate ‘Haufen’ shedding with the histologically confirmed course of PVN. | ClinicalTrials.gov ID: | Sponsor:
University of North Carolina, Chapel Hill and Astellas Pharma, Inc. |
Status:
Recruiting |
Belatacept Conversion Trial in Renal Transplantation
| Purpose: The purpose of this study is to learn if conversion to Belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied. | ClinicalTrials.gov ID: NCT00402168 | Sponsor:
Bristol-Myers Squibb |
Status:
Active, Not Enrolling |
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: | 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: | Sponsor:
Asellas Pharma Inc. |
Status:
Completed |