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Renal Insufficiency clinical trials

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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.

NCT ID: NCT01580306 Completed - Hepatitis C Clinical Trials

Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment

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

The main objective of this study is to investigate the influence of mild, moderate and severe renal impairment on the pharmacokinetics and safety of BI 201335 in comparison to a control group with normal renal function after single dose of BI 201335.

NCT ID: NCT01580046 Recruiting - Clinical trials for Kidney Failure, Chronic

Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction

RIPE
Start date: April 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.

NCT ID: NCT01579032 Completed - Clinical trials for CHRONIC RENAL FAILURE

Pulse Wave Analysis and Velocity in Patients With Chronic Renal Failure: a Cross-sectional Observational Study to Assess Association With Left Ventricular Hypertrophy, Uremic Toxins and Inflammation.

Start date: January 2004
Phase:
Study type: Observational

The aims of the presented study are as follows: 1. To evaluate the endothelial function and arterial stiffness in a large cohort of prevalent CKD patients by means of non-invasive applantion tonometry. 2. To evaluate the association between the serum levels of the representatives of the various classes of uremic toxins and markers of endothelial function and arterial stiffness. 3. To evaluate the association between markers of inflammation and oxidative stress and markers of endothelial function and arterial stiffness. 4. To evaluate the association between echocardiographic parameters and markers of arterial stiffness

NCT ID: NCT01578928 Completed - Renal Impairment Clinical Trials

A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers

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

The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal impairment.

NCT ID: NCT01575925 Completed - Multiple Myeloma Clinical Trials

Study of Pomalidomide to Evaluate the Pharmacokinetics and Safety for Patients With Multiple Myeloma and Impaired Renal Function (POM Renal)

POM Renal
Start date: June 1, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.

NCT ID: NCT01574157 Completed - Diabetes Mellitus Clinical Trials

Investigations of the Optimum Serum Bicarbonate Level in Renal Disease.

Start date: November 5, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to see if treatment with sodium bicarbonate will lower urine levels of proteins that are indicators of kidney damage in people with diabetes who also have chronic kidney disease.

NCT ID: NCT01572194 Terminated - Cystic Fibrosis Clinical Trials

Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC)

MUCO-IRC
Start date: April 2012
Phase: N/A
Study type: Interventional

Chronic renal failure is a serious complication of lung transplantation especially in patients with cystic fibrosis. Their medical history prior to the Lung Transplantation has already exposed to kidney damage. Post-lung transplantation, these patients are subjected to renal toxicity anticalcineurins they receive large doses. The measurement of renal function of patients by formula to estimate GFR in routine use is unreliable and other markers seem indispensable. The purpose of this study is to evaluate two markers, PIIINP (Procollagen III aminoterminal peptide N), whose urinary levels was correlated to the intensity of fibrosis in different types of kidney disease.

NCT ID: NCT01571999 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Assess the Safety and PK of GSK573719 and GSK573719/GW642444(VI) Combination in Healthy Subjects and Subjects With Severe Renal Impairment

Start date: March 29, 2012
Phase: Phase 1
Study type: Interventional

This study will assess the safety and pharmacokinetics of inhaled GSK573719 and GSK573719/vilanterol combination in healthy subjects and in subjects with severe renal impairment. The results of the study will provide guidance on the use of this product in subjects with severe renal impairment.