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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT01695759 Terminated - Anemia Clinical Trials

Clinical Efficacy of Two Erythropoietin Drug in Participants With Secondary Anemia to Chronic Kidney Disease.

Start date: December 2013
Phase: Phase 3
Study type: Interventional

This is a prospective, randomized, multicenter, parallel, placebo-controlled, phase III study for evaluation of clinical efficacy and immunogenicity of drug Eritromax® - (rHuEPO Blau Farmacêutica S/A.) compared to Eprex® (Janssen-Cilag rHuEPO) for the treatment of patients with secondary anemia to chronic kidney disease (CKD), throughout the correction phase by assessing the change in hemoglobin levels.

NCT ID: NCT01693744 Completed - Clinical trials for Chronic Kidney Disease

Pseudoexfoliation and Chronic Kidney Disease

Start date: October 2011
Phase: N/A
Study type: Observational

Background: Pseudoexfoliation (PEX) is characterised by the deposition of fibrillar material in an eye structures and many other parts of the body including kidneys and blood vessels. As both PEX and chronic kidney disease (CKD) are associated with oxidative stress and endothelial dysfunction we studied if the risk of PEX was increased in patients with CKD. Methods: Patients over age 40 with the diagnosis of CKD were included in the study. Chronic kidney disease was diagnosed as decreased glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m². Study groups were arranged as group 1 consisting of HD receiving patients, group 2 consisting of stage 1-4 CKD patients and group 3 consisting of patients with normal kidney functions (control group). Demographic properties and the rate of PEX were evaluated and compaired between the groups.

NCT ID: NCT01693029 Completed - Anemia Clinical Trials

Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa

ACCESS
Start date: September 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

NCT ID: NCT01688141 Completed - Clinical trials for Chronic Kidney Disease

A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease

Start date: January 2010
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from secondary care specialists will slow progression of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD registers. The investigators have partnered with Nene commissioning, a practice based commissioning group representing approximately 80 GP practices in Northamptonshire, to run this study. This will be a cluster randomised trial of an intensive, secondary care supported, CKD management programme in primary care vs normal CKD care. Randomisation will be at the level of the individual general practice. All general practices associated with Nene commissioning will be invited to participate. Randomisation of practices will be performed by the University of Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking randomised cluster trials. The aims of the study are: 1. To determine whether reinforcement of best practice in the management of key aspects of CKD care by clinical nurse specialists based in primary care, but with close links to colleagues from secondary care, improves clinical outcomes. 2. To foster excellence in CKD care 3. To improve coding of CKD and prevalence on chronic disease registers. 4. To increase interest in, and capacity for primary care research in Northamptonshire. 5. To implement and evaluate a new model of partnership working between primary and secondary care. The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR). Secondary outcome measures will be blood pressure control, proteinuria, incidence of cardiovascular events,other biochemical parameters, referrals to secondary care and hospitalisations and mortality.

NCT ID: NCT01686191 Active, not recruiting - Clinical trials for Heart Transplantation

Genetic Predictors of Renal Dysfunction Following Heart Transplantation

Start date: August 2012
Phase:
Study type: Observational

Kidney disease is a common problem after heart transplantation. It may be caused by anti-rejection medications such as cyclosporine or tacrolimus. However, the reason why some people develop kidney problems after a heart transplant, but other people do not, is not fully known. This study plans to learn more about the relationship between a person's genetic make-up (DNA; deoxyribonucleic acid) and the risk of kidney problems after a heart transplant. The long-term goal of this research is to identify genetic variations that may help predict the development of kidney problems after heart transplantation.

NCT ID: NCT01685086 Recruiting - Clinical trials for To Monitor the Occurrence of Active Tuberculosis

Surveillance and Follow-up for Latent Tuberculosis Infection and Observation of the Effect of Prophylactic Latent Tuberculosis Treatment in Patients With Severe Chronic Kidney Disease or Receiving Long-term Dialysis

Start date: March 2012
Phase: N/A
Study type: Observational

To follow-up the latent tuberculosis infection and evaluate the risk of developing active tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis

NCT ID: NCT01681303 Completed - Clinical trials for Chronic Kidney Disease

Effect of An Oral Absorbent AST-120 in Late-stage Chronic Kidney Disease (CKD) Patients.

Start date: January 2009
Phase: Phase 4
Study type: Interventional

Recent research work has directed especial attention toward a distinct group of uremic retension molecules, called "protein-bound uremic toxins". The prototypes of this group of uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production of free radical and impair antioxidant system and exerts direct toxicity on different cells and organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of these protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis of kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic patients. In hemodialysis, high serum p-cresol level is associated with higher cardiovascular mortality. AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It has superior adsorption ability for certain small-molecular weight organic compounds known to accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it was reported that AST-120 suppressed the increase in serum creatinine levels, prevented proteinuria, improved uremic symptoms, and, consequently, led to the postponement of dialysis therapy. Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the morbidity- mortality of CKD patients. The principal aim of this prospective cohort study is to investigate the effectiveness of AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of this relationship can help to establish new therapeutic strategy in the treatment of late-stage CKD patients.

NCT ID: NCT01680198 Completed - Clinical trials for Chronic Kidney Disease.

Paricalcitol and Endothelial Function in Chronic Kidney Disease Patients (the PENNY Study)

PENNY
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The primary aim of this study was to test the hypothesis that Paricalcitol, an active form of vitamin D, improved endothelial function in stage 3-4 chronic kidney disease (CKD) patients. A secondary aim of this trial was to study the relationship between endothelial function and plasma/serum and genetic biomarkers of bone mineral disorders in CKD (BMD-CKD) and renin angiotensin-aldosteron system (RAS) (angiotensin II and plasma renin activity).

NCT ID: NCT01679587 Completed - Kidney Diseases Clinical Trials

Dose Escalation Study to Investigate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BAY85-3934 in Subjects With Chronic Kidney Disease (CKD)

Start date: September 2012
Phase: Phase 1
Study type: Interventional

Primary objective was to assess in subjects with CKD: Safety and tolerability of molidustat (BAY 85-3934), effects of molidustat on non-invasive hemodynamics Secondary objectives were to assess: Effects on pharmacodynamic parameters of erythropoiesis (erythropoietin, reticulocytes, erythrocytes, hemoglobin, hematocrit), pharmacokinetics of molidustat, exploratory biomarkers, ie, midregional pro-atrial natriuretic peptide, midregional pro-adrenomedullin, plasma renin activity, and optionally B-type natriuretic peptide, vascular endothelial growth factor, cyclic guanosine monophosphate, cyclic adenosine monophosphate, and noradrenaline

NCT ID: NCT01675557 Completed - Clinical trials for Chronic Kidney Disease

Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney Disease Patients on Chronic Hemodialysis

Start date: September 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney Disease subjects requiring chronic hemodialysis.