Study of Induction Treatment With Velcade and Dexamethasone for Previously Untreated Patients With...
Multiple MyelomaPrimary outcome measure: Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment Secondary outcome measures: Study the speed of response and the response rate (M component in serum and urine protein) after each bortezomib/dexamethasone cycle Compare the efficacy of the bortezomib/dexamethasone therapy against the therapy without bortezomib Reversibility of renal failure Predictive value in the light chain determination for response and reversibility of renal failure Early morbidity (< 2 months) Progression-free survival Overall survival The safety outcome consists in: Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity criteria of clinical and laboratory events
Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin...
Diabetes MellitusType 2Primary Objective: >To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. Incidence of confirmed symptomatic and nocturnal hypoglycemia. Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment. Creatinine clearance at baseline and after each period of treatment. Overall safety: Incidence of adverse events.
Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis...
Restless Legs SyndromeKidney Failure1 moreThe purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.
A Study of the Pharmacokinetics of ER OROS Paliperidone in Volunteers With Normal or Impaired Renal...
SchizophreniaRenal ImpairmentThe purpose of this study is to evaluate the pharmacokinetics of a single oral dose of 3 mg extended release paliperidone (ER OROSÃ' paliperidone) in patients with varying degrees of renal impairment (mild, moderate, and severe), compared to patients with normal renal function. Secondary objectives include the assessing the disposition of the (+) and (-) enantiomers by means of an enantioselective liquid chromatography mass spectrometry assay, to determine plasma protein binding of the enantiomers in patients with impaired renal function, compared with patients with normal renal function, and to evaluate the tolerability and safety profile of ER OROS paliperidone in patients with varying degrees of renal impairment (mild, moderate, and severe) compared with patients with normal renal function.
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and...
Diabetes MellitusType 21 moreThis clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 52 weeks.
Safety of Gadovist in Renally Impaired Patients
FibrosisRenal ImpairmentPatients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate. The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product...
Chronic Renal FailureThe primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of hemodialysis.
Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant...
Kidney FailureRenal FailureThe purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a transplanted kidney. LCP-Tacro is a tablet containing the same active ingredient (tacrolimus) that is in Prograf capsules, but the tablet has been designed to release tacrolimus over an extended period so that it only has to be taken once daily. LCP-Tacro is an investigational drug. This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a kidney transplant in patients randomly assigned (by chance, like flipping a coin) to take either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In addition, patients will remain on study drug for 360 days in order to evaluate the relative safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.
Safety and Tolerability of Vildagliptin Versus Sitagliptin in Patients With Type 2 Diabetes and...
Diabetes MellitusType 2This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) and sitagliptin (25 mg qd) when used in patients with type 2 diabetes mellitus(T2DM) and severe renal insufficiency (Glomerular filtration rate (GFR) < 30 mL/min) for a period of 24 weeks.
Effects of MK7418 on Diuresis and Renal Function in Congestive Heart Failure Patients
Congestive Heart FailureRenal ImpairmentA study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.