Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI)...
Complicated Skin and Skin Structure InfectionsS. Aureus Bacteremia1 moreThis is a multicenter, randomized, evaluator-blinded, comparator-controlled study. Participants were to be randomized (1:1) to daptomycin or comparator, stratified by degree of renal impairment (creatinine clearance [CLcr] 30 - 50 milliliters per minute [mL/min] [moderate impairment] and <30 mL/min [severe impairment]) and by type of infection (bacteremia and complicated skin and skin structure infections [cSSSI]) to create 4 cohorts defined as follows: Cohort 1: Bacteremia and CLcr <30 mL/min Cohort 2: Bacteremia and CLcr 30 - 50 mL/min Cohort 3: cSSSI and CLcr <30 mL/min Cohort 4: cSSSI and CLcr 30 - 50 mL/min Participants will be treated and evaluated for safety and microbiological and clinical efficacy in accordance with their type of infection and degree of renal impairment. Peak and trough samples will be collected to assess exposure to daptomycin for participants on Day 1 and following the 5th dose.
High Cut-Off Continuous Veno-venous Hemodialysis (CVVHD) in Patients Treated for Acute Renal Failure...
Systemic Inflammatory Response SyndromeKidney Failure1 moreThis study will assess the influence of the High Cut-Off (HCO) CVVHD treatment on the disease progression in septic patients. The primary aim of the study is to evaluate whether HCO CVVHD leads to a significant improvement of the hemodynamic status (mean arterial pressure, vasopressor requirements) in septic patients in comparison to CVVHD treatment with conventional high-flux filters. For the HCO-group the investigators expect a 50% lower dosage of vasopressors needed to maintain an adequate organ perfusion.
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in...
Chronic Kidney Disease (CKD) Stage 5Hypertrophy1 moreTo evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).
Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride...
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 haemodialysis, compared with a marketed phosphate binder, sevelamer hydrochloride.
The Effects of Carperitide on Short and Long-term Prognosis in Patients With Both Cardiac and Renal...
Heart FailureRenal FailureCarperitide (alpha-human atrial natriuretic peptide) improves systemic hemodynamics in patients with heart failure through a vasodilatory action, a natriuretic action, and inhibition of the renin-angiotensin-aldosterone system and has been widely-used in Japan. However, a paucity of report is available on the effects of carperitide on short and long-term prognosis in patients with both cardiac and renal failure. The purpose of this study is to evaluate the effects of carperitide therapy on short and long-term prognosis in patients with both cardiac and renal failure, in comparison with standard therapy.
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus...
AtherosclerosisKidney FailureThe purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.
An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate
Chronic Kidney FailureFermagate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb. The purpose of this study it to look at the safety of fermagate over longer periods of time.
External Ionizing Radiation to Prevent Restenosis on Haemodialysis Vascular Access
Renal InsufficiencyChronic4 moreAlthough ionizing radiations have been proposed for the prevention of intimal hyperplasia in coronary and peripheral arteries, information is lacking on how irradiation may prevent neointimal smooth-muscle cell proliferation and restenosis on prosthetic haemodialysis vascular access. We will assess the preventive effect of one dose of radiations (14 Gy) administered transcutaneously one day after dilatation of stenosis on prosthetic haemodialysis vascular access in a randomized controlled trial with a standardized clinical and ultrasonographic one-year follow-up.
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
Congestive Heart FailureCardiac Transplantation2 moreThe purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country equivalent) cardiac transplant candidates are to assess the safety and efficacy of Natrecor (nesiritide). The study will evaluate the drug's ability to prevent clinical worsening when administered as a 28-day continuous intravenous infusion in patients receiving standard care and continuous intravenous infusion of dobutamine or milrinone.
Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C, 10%
Kidney FailureChronicThe purpose of this study is to determine if IGIV-C, 10% will be effective in converting a donor-recipient crossmatch status from positive to negative. The crossmatch test is used to determine if the donor tissue and recipient tissue are compatible. The study will also evaluate if IGIV-C, 10% will allow successful kidney transplantation in a patient who otherwise would not be able to receive a transplant. Three dose levels of IGIV-C, 10% will be evaluated to determine what dose level is most effective.