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.
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.
The Clinical Evaluation of the Dose of Erythropoietins Trial
Kidney FailureChronicAnaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are the most used treatment option. The purpose of this study is the evaluation of biochemical markers to determine the efficacy of individual prediction of ESAs therapy to determine the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).
The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney...
Chronic Renal InsufficiencyProteinuriaA randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.
Three Times Weekly (TIW) Growth Hormone Therapy in Children on Hemodialysis
Kidney FailureChronic1 moreHypotheses: The provision of thrice weekly subcutaneous (SQ) recombinant growth hormone (rGH) therapy to children receiving in-center hemodialysis (HD) will result in improved growth. The provision of thrice weekly SQ rGH therapy to children receiving in-center HD will result in improved lean body mass, nutritional status and quality of life. TIW rGH treatment regimen (0.35 mg/kg/week divided into 3 doses, each dose being given at the conclusion of the dialysis treatment) for up to 2 years; growth response, Dual energy X-ray absorptiometry (DEXA), and quality of life (QOL) will be measured. The goal is to enroll 20 children who are Tanner 1 with decreased height SDS and/or decreased height velocity standard deviation scoreS (SDS). If this therapy is demonstrated to be efficacious and improves growth and QOL, this therapy could be easily implemented for all eligible children on HD, since parental acceptance should be better without having to administer the rGH at home and compliance for the child will be assured. The investigators thus propose an important study that has the ability to advance their understanding and provide evidence for the best methods to promote growth in children on dialysis. The results of this study will result in important information that will be of value to the entire pediatric nephrologist community, including health care professionals, patients, and families. In a real sense, this study will build on the 2006 Consensus Conference guidelines for evaluation and treatment of growth failure in children with chronic kidney disease (CKD). This will provide evidence for critical management decisions that can help insure better growth opportunities to more children with CKD.
Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency
Type 2 DiabetesRenal InsufficiencyIt is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR by MDRD as follows: < 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based calculation.
Reducing Donor Specific Antibody (DSA) Strength in Maintenance Kidney Transplant Recipients (DSA...
Transplant; FailureKidneyThe purpose of this study is to demonstrate that increased dosages of mycophenolic acid in maintenance kidney transplant recipients may cause a reduction in donor-specific antibodies.
Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients...
Renal InsufficiencyChronic2 moreThis study assesses the effects of a new formulation of bardoxolone methyl on eGFR in Patients with Chronic Kidney Disease and Type 2 Diabetes.
Effect of Strict Blood Pressure Control and ACE-Inhibition on Progression of Chronic Renal Failure...
ChildrenChronic Renal Failure3 moreIn children with chronic kidney disease, progression to end-stage renal failure is associated with high patient morbidity and poor quality of life. In adults, inhibition of the renin angiotensin system (RAS) slows down the rate of renal failure progression. This concept is as yet unproven in children, in whom chronic renal failure (CRF) is more commonly due to hypo/dysplastic malformations than to acquired glomerulopathies as typical for adult chronic kidney disease. The current project aims at assessing the genetic and molecular mechanisms and cardiovascular consequences of progressive CRF and to develop a strategy of pharmacological renoprotection in children.
BNP for Cardio-Renal Decompensation Syndrome (BNP-CARDS)
Congestive Heart Failure ExacerbationRenal InsufficiencyMany patients with exacerbations of heart failure have significant concomitant kidney dysfunction. The combination of these two conditions makes pharmacological management difficult. In this study, we plan to randomize patients with heart failure and kidney dysfunction to receive infusions of Natrecor (B-type Natriuretic Peptide)--which may be beneficial to the management of these two diseases--or placebo.