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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT00451295 Terminated - Clinical trials for Chronic Kidney Disease

A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia

Start date: May 2007
Phase: Phase 3
Study type: Interventional

This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.

NCT ID: NCT00446615 Not yet recruiting - Clinical trials for Chronic Kidney Disease

Multifaceted Intervention to Improve Prescribing in Patients With Chronic Kidney Disease

Start date: March 2007
Phase: N/A
Study type: Interventional

In 2001, an estimated 1.9 million Canadians had chronic renal disease and the number of patients being treated for end stage renal disease climbed by nearly 20% in 5 years. Many medications commonly used in elderly patients are excreted by the kidney. Failure to adjust doses in those with impaired renal function can result in medication overdose, leading to potentially serious morbidity and mortality. Studies in hospitals and long term care facilities have found a 19-67% rate of non-compliance with guidelines for medication dose adjustment in patients with renal insufficiency and in ambulatory care one study found a 69% rate of non-compliance. Since primary care physicians write 80% of prescriptions for those aged 65 years, there is a need for interventions to improve prescribing to patients with renal impairment in primary care. This study will develop an audit tool and electronic decision support tool that will be incorporated into the electronic medical record in a large academic family health centre. It is seen as a preliminary step in a project to assess the effectiveness of a multifaceted intervention including chart audit, personalized feedback to prescribers, a pharmacist-facilitated group learning session and the use of an electronic decision support tool incorporated into the electronic medical record.

NCT ID: NCT00442793 Completed - Anemia Clinical Trials

A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Start date: May 2007
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00442702 Completed - Anemia Clinical Trials

A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

Start date: September 2007
Phase: Phase 3
Study type: Interventional

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00442299 Suspended - Clinical trials for Chronic Kidney Disease

Albumin Dialysis in End-Stage Renal Disease: Detoxification Capacity and Impact on Vascular Endothelial Function

Start date: April 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The uremic syndrome is mainly related to the retention of a host of compounds, due to altered glomerular filtration and other factors of renal dysfunction, e.g. tubular secretion. Uremic retention solutes are arbitrarily subdivided in three different categories according to their physicochemical characteristics and their subsequent behaviour during dialysis: (i) the small, water-soluble, non-protein bound compounds, (ii) the larger middle molecules, mainly peptides and (iii) the small protein-bound compounds (1). Although direct proof is lacking, several lines of evidence indicate that albumin is the most important carrier protein. Removal of protein bound uremic retention solutes is limited. The Prometheus® system fractionates blood into plasma and cellular components, using an albumin-permeable polysulfon filter (AlbuFlow®) with a specially designed sieving coefficient curve (1.0 for 2-microglobulin, >0.6 for albumin, <0.3 for IgG, <0.1 for fibrinogen and <0.01 for IgM). Due to the high sieving coefficient of the filter for large molecules (i.e. cut-off at about 250 kD) molecules up to the size of albumin (69 kD) easily pass from blood into the secondary circuit which is filled with isotonic sodium chloride solution, whereas larger molecules like fibrinogen (340 kD) cannot pass through the filter. In the secondary circuit the filtered plasma with the albumin-bound toxins flows through one or two adsorbers in a row with maximized adsorption capacity for putative liver toxins that are directly adsorbed (`fractionated plasma separation and adsorption' or FPSA). The purified plasma is then returned to the blood side of the albumin filter. In order to eliminate water-soluble toxins, blood thereafter undergoes hemodialysis using a conventional high-flux dialyser. We hypothesise that removal of protein bound uremic retention solutes can be improved by FPSA as compared to standard hemodialysis.

NCT ID: NCT00441623 Completed - Clinical trials for Chronic Kidney Disease

The Role of P-cresol and Related Protein Fermentation Metabolites in Chronic Kidney Disease Patients

Start date: October 2005
Phase: N/A
Study type: Observational

Study on the natural history of uremic retention solutes in patients with mild-to-moderate chronic kidney disease

NCT ID: NCT00441545 Completed - Clinical trials for Chronic Kidney Disease, Stage 5

Head to Head Study Against Sevelamer Hydrochloride

Start date: January 5, 2007
Phase: Phase 3
Study type: Interventional

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

NCT ID: NCT00440648 Completed - Clinical trials for Chronic Kidney Disease

Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

Start date: March 2005
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks

NCT ID: NCT00440557 Completed - Anemia Clinical Trials

An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease

Start date: September 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.

NCT ID: NCT00440466 Completed - Anemia Clinical Trials

PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients

Start date: July 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that once every-2-weeks and once every-4-weeks treatment with epoetin alfa, a drug that increases red blood cell production, in patients with anemia associated with chronic kidney disease, is not less effective than treatment with epoetin alfa that is given once a week