The Everolimus-Transplant Exit Strategy Trial (E-TEST)
Kidney FailureChronicThe purpose of this study is to test the safety and effectiveness of everolimus (Zortress®) in preventing antibody formation in patients with chronic failing kidney transplants. Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the prevention of rejection in kidney transplant. The primary objective for the study is to determine whether conversion of patients with chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent allosensitization. The secondary objective will be to determine whether conversion of patients with chronic renal graft failure to everolimus (elimination of calcineurin inhibitor) will delay the onset of dialysis.
Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients
Kidney TransplantationAnemia3 moreThe purpose of this study is to evaluate the effect of anemia correction and vitamin D supplementation in kidney transplant recipients.
The ONE Study M Reg Trial
Renal FailureEnd StageTo collect evidence of the safety of administering donor-derived regulatory macrophage (M reg) preparations to living-donor renal transplant recipients in the context of an international European Union funded consortium aimed at evaluating cellular immunotherapy in solid organ transplantation (The ONE Study). It is anticipated that immune regulation induced by M reg therapy can eventually be used to reduce the need for conventional immunosuppression in transplant recipients.
Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion...
Kidney FailureAn open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
A Dose Conversion Study of Epoetin Alfa in Subjects With the Anemia of Chronic Kidney Disease.
AnemiaChronic Renal InsufficiencyThe purpose of this study was to evaluate hemoglobin stability in subjects who had received darbepoetin alfa for a minimum of 3 months prior to study entry who were then converted to epoetin alfa at the same dosing frequency to maintain a hemoglobin level of 12 plus or minus 1 g/dL (range 11-13- g/dL).
Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate
Chronic Kidney FailureMagnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb. The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including...
PK Properties Of Gabapentin In Subjects With Impaired Renal FunctionTo confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package insert to Japanese.
Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency
Renal InsufficiencyHeart FailureThe main purpose of this study is to determine the safety and tolerability of tonapofylline (BG9928) when given at different doses to patients with heart failure and renal insufficiency. This study will also explore: Disease related quality-of-life Exercise capacity Renal function Concomitant medications
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia...
Chronic Renal FailureChronic Kidney Disease1 moreThe purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.
REPEAT Study - Resistance to ErythroPoietin Effectiveness Algorithm Trial
Kidney FailureChronic1 moreA strategy for optimizing erythropoietin therapy in patients with erythropoietin resistance. A multi-centered, open-label, randomized, controlled trial.