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Renal Insufficiency clinical trials

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NCT ID: NCT01208818 Completed - Clinical trials for Chronic Renal Failure With Uremic Nephropathy

Studies in Patients With Multiple Myeloma and Renal Failure Due to Myeloma Cast Nephropathy

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

MYRE is a phase III multicentric controlled national clinical trial conducted in patients with multiple myeloma and renal failure related to myeloma cast nephropathy (MCN). Its aims are to assess (1) the efficacy of bortezomib plus dexamethasone (BD), compared with cyclophosphamide, plus bortezomib and dexamethasone (C-BD) in patients with inaugural MCN not requiring hemodialysis; and (2) in patients with inaugural severe renal failure secondary to biopsy-proven MCN and requiring hemodialysis that of an intensive hemodialysis regimen using either a dialyser with very high permeability to proteins (TheraliteTM) or a conventional high-flux dialyser, while receiving chemotherapy with BD.

NCT ID: NCT01207297 Completed - Clinical trials for End-stage Renal Disease

Tacrolimus Versus Cyclophosphamide as Treatment for Lupus Nephritis

Start date: March 2003
Phase: Phase 1
Study type: Interventional

In this comparative open-label cohort study, the investigators compared the efficacy and safety of tacrolimus (TAC)and cyclophosphamide (CYC) in the treatment of diffuse proliferative and membranous lupus nephritis with severe renal disease. Treatment of lupus nephritis (LN) with cyclophosphamide is effective, but retain a certain proportion of renal function exacerbations. Tacrolimus may be a suitable substitute treatment for CYC. Methods: Forty patients with diffuse proliferative or membranous were recruited for this trial, 45% of them had lower Ccr (<60mL/min/1.73m2), 10% had increased serum creatinine (>180µmol/L) and 67.5% had nephritic proteinuria (>3.5g/day). The investigators compared the efficacy and adverse effects of TAC (0.04-0.08 mg/kg/d) and prednisone for 12 months (TAC group) with pulse cyclophosphamide (750mg/m2 per month for six months) and prednisone followed by azathioprine (50mg/day)for 6 months (CYC group).

NCT ID: NCT01204645 Recruiting - Clinical trials for Myocardial Infarction

Karolinska Cardiorenal Theme-centre and StockholmHeartbank

KKT
Start date: May 2010
Phase: N/A
Study type: Observational

Chronic kidney disease (CKD) affects 10-18% of the adult population and is becoming recognized as one of the most serious disorders causing increased risk for cardiovascular disease and death. In patients with ischemic heart disease 26% have increased creatinine, which rises to 40% if patients also have diabetes mellitus. Risk increases as renal function diminishes, and just slowing the rate of decline in renal function would have a tremendous impact on health and morbidity. This association is commonly termed the Cardiorenal Syndrome, though it is caused by a much more complex interplay between major pathogenetic pathways such as glucose metabolism and diabetes, systemic and tissue inflammation, tissue metabolism, coagulation, mineral metabolism, sympathetic activation, renin-angiotensin-aldosterone system activation, endothelial dysfunction, lipid metabolism, fetal programming etc. Karolinska Institutet recently merged basic and clinical researchers in all these fields, creating a Karolinska Kardiorenal Theme Centre; ultimately aiming to explore the syndrome and provide improved care for the individual patient. The investigators road to success: - Creating a Biobank (blood, DNA, plasma) from the majority of all hosptalized patients with ACS in Stockholm county - Stockholmheartbank. - This Theme Center include all teaching hospitals associated with Karolinska Institutet; Danderyd University Hospital, Karolinska University Hospital and Södersjukhuset University Hospital. Together theses hospitals serve as emergency hospitals for 1.9 million people. The investigators are aiming at creating a biobank from all patients admitted for an acute coronary event (about 2.300/yr), which is a unique asset for molecular and genetic research as well as observational and intervention studies. - The investigators have access to the National registry with 100% coverage, that contains data on all patients admitted to Stockholms coronary care units since 1995. - To ensure translation in to clinical practice, most of the researchers are also MD:s, and several are clinically active. - The clinical network facilitates the development of novel therapies and translational research. - Steering groups for Education and a Clinical Practice implementation program.

NCT ID: NCT01202708 Completed - Clinical trials for Chronic Renal Failure

Gambro AK200 ULTRA Hemodiafiltration Study

Start date: August 1997
Phase: N/A
Study type: Interventional

This study is designed to assess the safety, efficacy and dialytic capabilities of hemodiafiltration with on-line prepared substitution fluid using the AK200 ULTRA in comparison to conventional hemodialysis.

NCT ID: NCT01200290 Completed - Clinical trials for Kidney Failure, Chronic

A Study in Participants With End-Stage Renal Disease

Start date: April 2011
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to explore the effect of LY2127399 on those antibodies that are a barrier to kidney transplant. Transplantation is currently the definitive treatment for End-Stage Renal Disease (ESRD), providing prolonged survival and improved quality of life.

NCT ID: NCT01191905 Completed - Sepsis Clinical Trials

Effects of HIgh Volume COntinuous REnal Replacement Therapy in Patients With Septic Acute Kidney Injury

HICORES
Start date: January 2011
Phase: N/A
Study type: Interventional

Acute kidney injury (AKI) is a common and serious problem in critically ill patients, and is known to be an independent risk factor for mortality. Among the various etiologies of AKI, sepsis or septic shock is the most frequent contributing factor especially in an intensive care unit setting. Also, the mortality of septic AKI in these patients still remains extremely high despite recent marked therapeutic advance. Given the physiologic superiority of continuous renal replacement therapy (CRRT) on uremia and volume control, it has become the modality of choice in critically ill patients with AKI. In addition, CRRT can theoretically provide immunohomeostasis through the convective and adsorptive removal of various immune mediators. Although the pathophysiology of septic AKI remains elusive, it has become increasingly recognized that many pro- and anti-inflammatory mediators, such as TNF, IL-6, IL-8 and IL-10, play an important role in this process. Therefore, it has been speculated that the reduction of cytokines by increasing CRRT dose in patients with septic AKI may reduce mortality risk. Even though recent two large scale randomized controlled trials, ATN and RENAL study, have failed to show the difference in survival rate between the clearance of 20~25 ml/kg/hr and 35~40 ml/kg/hr, none of these studies were designed to elucidate the survival benefit of high intensity CRRT in patients with septic AKI. Moreover, the optimal target CRRT dose in these patients is not well established and may be even higher than 35~40 ml/kg/hr in terms of septic AKI. Indeed, recent several uncontrolled trial have shown the survival benefit of high intensity CRRT in these patients. To further explore the effects of high dose CRRT on survival of critically ill patients with septic AKI, the investigators will conduct a multicenter prospective randomized controlled open-label trial which compares the difference in survival rate between 1:1 balanced pre-dilution CVVHDF at 80 vs. 40 mL/Kg/hr for initial 72hrs after the start of CRRT. The primary end-point of this study is the effect of high volume pre-dilution CVVHDF on 28-day survival rate. The secondary end-point is 60- and 90-day mortality, ICU and in-hospital mortality, duration of CRRT and renal replacement therapy, duration of mechanical ventilation, cytokine removal rate at 12h after the initiation of CRRT, and changes in SOFA and APACHE II score at 72h after the initiation of CRRT. This is a superiority trial which aims to demonstrate a reduction of 20% or more in mortality rate. For this purpose, at least 109 subjects (a total of 218) would be required for each group if type I error rate is 5% and type II error is 20% given 25% of drop-out rate during the study period. Block randomization will be used by means of a dedicated website. There are still conflicting data on the optimal target dose of CRRT in patients with septic AKI. Our study will address this issue to answer the unresolved question on the effect of high dose CRRT.

NCT ID: NCT01191255 Completed - Kidney Failure Clinical Trials

A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

Start date: October 2010
Phase: Phase 3
Study type: Interventional

This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

NCT ID: NCT01186276 Completed - Clinical trials for Kidney Failure, Chronic

Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

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

This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.

NCT ID: NCT01184989 Completed - Clinical trials for Arthroplasty, Replacement

Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate

Start date: August 2010
Phase: Phase 4
Study type: Interventional

To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study will be conducted.

NCT ID: NCT01181544 Completed - Clinical trials for Renal Failure Chronic Requiring Hemodialysis

A Pilot Study of a Heparin Dosing Algorithm for Hemodialysis

Start date: March 2011
Phase: N/A
Study type: Interventional

During hemodialysis treatments, patients receive heparin to prevent clotting. The purpose of this pilot study is to determine if the amount of heparin administered during a patient's hemodialysis can be individualized using an equation for heparin dose adjustment.