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Renal Insufficiency clinical trials

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NCT ID: NCT01619033 Completed - Renal Impairment Clinical Trials

Pharmacokinetics of BF2.649 in Renal Impairment

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This is an open, parallel group study in subjects with normal renal function compared to those with renal dysfunction.

NCT ID: NCT01617824 Completed - Type 2 Diabetes Clinical Trials

Rapid Effects Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetes

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

Diabetes mellitus is characterized by chronic low grade inflammation, which is worsened by the co-existence of renal failure. One key aspect of chronic inflammatory diseases is the alteration in the polarization profile of circulating monocyte-macrophage cells. Namely, monocytes-macrophages can exist in a pro-inflammatory (M1) polarized form or an anti-inflammatory (M2) polarized state. Alterations in the M1/M2 balance is thought to contribute to inflammation within atherosclerotic lesions and visceral adipose tissue which, in turn, can worsen cardiovascular disease and metabolic features in type 2 diabetic patients. M1 and M2 are regulated by a complex interplay of soluble signaling molecules, many of which are substrate of the enzyme DPP-4 (dipeptidyl peptidase-4). Therefore, inhibition of DPP-4 can affect the M1/M2 polarization balance. In this clinical trial, the investigators will test whether the DPP-4 inhibitor Linagliptin, compared to placebo, modifies the M1/M2 balance in type 2 diabetic patients with and without chronic renal failure. In addition, we will test whether DPP-4 inhibition with Linagliptin acutely affects endothelial progenitor cells (EPCs), which are vasculoprotective cells implicated in the pathobiology of diabetic complications.

NCT ID: NCT01613690 Completed - Renal Impairment Clinical Trials

Comparing the Pharmacokinetics, Safety and Tolerability of NVA237 in Renal Impairment

Start date: June 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see how the body processes and gets rid of NVA237 in people who have impaired kidney function compared to people whose kidney function is normal.

NCT ID: NCT01612429 Completed - Clinical trials for End Stage Renal Failure on Dialysis

Carbamylation in Renal Disease-modulation With Amino Acid Therapy

CarRAAT
Start date: January 2013
Phase: Phase 0
Study type: Interventional

This is a pilot study to evaluate the effects of amino acid supplementation on the structure of certain proteins in the blood of dialysis patients. Patients with end stage renal disease (ESRD) usually have high levels of urea that may interact with blood proteins and change their structure by a process known as carbamylation. The investigators are interested in determining whether carbamylation is linked to adverse outcomes in dialysis patients and have hypothesized that supplementation with a balanced formulation of amino acids can reduce the amount of carbamylation that occurs. In this study, dialysis patients (n= up to 30) will receive intravenous supplementation with an FDA-approved amino acid solution (NephrAmine®, 5.4% amino acids) during regular dialysis sessions (3 times weekly for 6 weeks). During the 6 weeks of therapy and for 2 weeks of follow-up, blood will be drawn from patients' existing hemodialysis access ports (~60 ml total per month) to measure levels of carbamylated albumin, amino acids, and standard laboratory values. Patients will be closely monitored for safety and tolerability of the amino acid therapy. For each treated subject, we will follow an additional individual that is not receiving treatment to serve as a control (no intervention).

NCT ID: NCT01612117 Completed - Renal Failure Clinical Trials

Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) in Invasive Cardiology

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

Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration. This study will be conducted to assess the possible value of urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP) and whether or not uNGAL correlates with the volume of contrast medium (CM) used.

NCT ID: NCT01612013 Completed - Acute Renal Failure Clinical Trials

Intravenous High Dose NAC and Sodium Bicarbonate for the Prevention of Contrast-induced Acute Injury

Start date: May 2005
Phase: N/A
Study type: Interventional

Contrast-induced acute kidney injury is a common cause of acquired in-hospital renal insufficiency and is associated with prolonged hospitalization and unfavorable early and late outcomes. The investigators sought to compare 4 different strategies (intravenous high-dose of N-acetylcysteine, sodium bicarbonate, the combination of both, and saline alone) in the prevention of contrast-induced acute kidney injury in patients undergoing coronary angiography using high-osmolar contrast media defined by creatinine and cystatin C serum levels.

NCT ID: NCT01593787 Completed - Clinical trials for Hypertension With Renal Dysfunction

Safety and Tolerability and Efficacy of LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction

Start date: May 2012
Phase: Phase 3
Study type: Interventional

This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.

NCT ID: NCT01582867 Completed - Renal Failure Clinical Trials

HemoControl System Activated in Hemodiafiltration Treatments

SOCRATHE
Start date: May 2012
Phase: N/A
Study type: Interventional

The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.

NCT ID: NCT01581996 Completed - Clinical trials for End-stage Renal Disease

Fosrenol and Phosphorus Balance - Lanthanum Carbonate

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

Positive phosphorus balance and hyperphosphatemia (increased serum phosphorus levels) are very common complications of people with advanced chronic kidney disease (i.e., stage 5 CKD), including chronic dialysis patients, and are associated with severe morbidity and increased mortality. Despite attempts to control serum phosphorus with dietary phosphorus restriction and the use of medicines that bind phosphorus in the gastrointestinal tract so that the phosphorus cannot be absorbed into the body( also called phosphate binders), chronic dialysis patients frequently remain hyperphosphatemic, particularly at the time when they commence each of their regular dialysis treatments. Fosrenol (lanthanum carbonate, manufactured by Shire Pharmaceuticals) is a gastrointestinal phosphate binder that appears to have the advantages of being safe, well tolerated and effective at binding phosphate. There are limited data on the magnitude of binding of phosphorus by Fosrenol in the human gastrointestinal tract of patients with chronic kidney disease. The specific aims for this proposal are as follows: 1. To quantify, under precisely controlled metabolic balance conditions, the increase in fecal excretion of dietary phosphorus that occurs when patients undergoing chronic peritoneal dialysis (CPD) ingest Fosrenol (lanthanum carbonate). 2. To examine a dose response relationship between Fosrenol treatment and fecal phosphorus excretion. The investigators will examine in CPD patients ingesting a constant phosphorus intake, how much additional phosphorus is excreted in the feces at three different dose levels of Fosrenol, 1.5, 3.0, and 4.5 g/day. 3. To examine how increased fecal phosphorus losses and more negative phosphorus balance caused by Fosrenol intake affects serum phosphorus and such hormonal regulators of phosphorus metabolism as serum parathyroid hormone (PTH), fibroblast growth factor-23, 25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3) and fetuin-A. 4. To assess whether there is any effect of Fosrenol and increased intestinal phosphate binding on protein-nitrogen balance.

NCT ID: NCT01581658 Completed - Clinical trials for Diabetes Mellitus, Type 2

Renal Impairment Study of Empagliflozin (BI10773) in Japanese Patients With Type 2 Diabetes

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

The objective of this study is to assess the effect of the different degrees of renal impairment on the pharmacokinetics, pharmacodynamics and safety of BI10773 following oral administration of high dose BI10773 as a single dose in Japanese patients with type 2 diabetes mellitus.