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Renal Insufficiency clinical trials

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NCT ID: NCT00597584 Completed - Anemia Clinical Trials

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

EMERALD 2
Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of peginesatide in the maintenance treatment of anemia in participants on dialysis.

NCT ID: NCT00596518 Completed - Clinical trials for Renal Insufficiency, Chronic

A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function

Start date: October 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.

NCT ID: NCT00587158 Completed - Clinical trials for Hyperparathyroidism, Secondary

Oral Paricalcitol in Kidney Transplant Recipients

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

This study is being done to find out whether patients who receive a kidney transplant can benefit from taking the medication paricalcitol (trade name Zemplar®) as compared to kidney transplant recipients not taking this medication. The main possible benefits being studied are: - Lower risk for overactive parathyroid glands after kidney transplantation. - Lower risk of low bone density in the spine and hip after kidney transplantation. By dividing patients in the study into a group receiving Zemplar® and a group not receiving Zemplar®, it will be possible to understand the good and bad effects of Zemplar® during the first year after a kidney transplant.

NCT ID: NCT00585143 Completed - Clinical trials for Dyslipidemia, Renal Insufficiency

Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly

Start date: January 2008
Phase: Phase 1
Study type: Interventional

Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly

NCT ID: NCT00584779 Terminated - Clinical trials for PK Properties Of Gabapentin In Subjects With Impaired Renal Function

An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis

Start date: October 2007
Phase: Phase 4
Study type: Interventional

To confirm the pharmacokinetics following administration of gabapentin to Japanese subjects with renal impairment, compare the results to Western study results and confirm the adaptive possibility of dose adjustment in US package insert to Japanese.

NCT ID: NCT00583765 Completed - Clinical trials for Kidney Failure, Acute

Evaluation of a Simplified Protocol for Regional Citrate Anticoagulation in Continuous Venovenous Hemodiafiltration

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

Dialysis requires thinning of the blood to prevent clotting in the dialysis machine. Thinning of the blood is necessary but some forms of blood thinners may cause bleeding. Therefore, researchers are seeking ways to minimize bleeding risks and ensure effective dialysis. One medication used to thin the blood in the dialysis machine is citrate. Citrate has the advantage of having its blood-thinning properties quickly reversed by calcium in the patient's blood. As a consequence, only the blood in the machine is thinned, greatly reducing the risk of bleeding when dialysis is carried out using other blood thinners. Until now, most patients who received citrate for dialysis were administered the citrate in a separate infusion through an IV pump into the dialysis machine. This method requires complex monitoring and calculations. This study is about Prismocitrate which is a dialysis fluid very similar to the regular dialysis fluid that is used in this intensive care unit, except that this fluid already contains exactly the correct amount of citrate. Thus, this method does not require a separate pump for citrate and calculations to pump the citrate into the blood as it goes through the kidney machine. Having the citrate already contained in the dialysis fluid simplifies the procedure and reduces the possibility of calculation errors. This study seeks to determine if this simplified means of providing blood thinning in the kidney machine also results in the correct balance of blood salts.

NCT ID: NCT00580047 Completed - Renal Insufficiency Clinical Trials

Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants

Start date: December 1, 2003
Phase: N/A
Study type: Interventional

The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.

NCT ID: NCT00575484 Terminated - Clinical trials for Congestive Heart Failure

Concentrated Saline Infusions and Increased Dietary Sodium With Diuretics for Heart Failure With Kidney Dysfunction

Start date: November 2007
Phase: Phase 2
Study type: Interventional

At present the standard management of fluid overload in patients with congestive heart failure (CHF) involves limiting the intake of salt and water while administering high dose diuretics, often at the cost of deteriorating kidney function. However, another group of researchers has previously shown that intravenously infusing small volumes of concentrated saline during diuretic dosing and liberalizing dietary salt intake while continuing to limit water consumption resulted in improved fluid removal in CHF patients. Furthermore, less deterioration in kidney function, shorter hospitalizations, reduced readmission rates, and even reduced mortality were observed. The present study will examine this novel therapy in a population of 60 patients with underlying severe CHF and kidney dysfunction hospitalized for the management of fluid overload. Half of these patients will receive investigational treatment with concentrated salt infusions and liberalized salt consumption during diuretic therapy. All patients will otherwise receive the standard therapies for heart failure, including restrictions on water consumption. This study will attempt to verify the improvements in clinical endpoints previously described and define the mechanisms of enhanced fluid removal.

NCT ID: NCT00575419 Terminated - Clinical trials for Contrast Induced Nephropathy

Safety Study Of N-Acetylcysteine For Prevention Of Contrast Induced Nephropathy In Patients w/Stage 3 Renal Failure

CIN-NAC
Start date: November 2007
Phase: Phase 1
Study type: Interventional

This will be a randomized prospective dose escalation clinical study of N-acetylcysteine (NAC) in patients with stage 3 or worse renal failure (Glomerular Filtration Rate 30-60 ml/min calculated with the Modification of Diet in Renal Disease formula), undergoing a procedure or imaging that requires the administration of contrast media at Oregon Health & Science University or the Portland Veterans Hospital. Subjects will receive NAC 60 minutes prior to the procedure or imaging requiring contrast media. Toxicity will be graded according to NCI Common Toxicity Criteria (CTC) version 3.0. An adult Phase 1 dose escalation study of NAC administered intravenously (IV) and intra-arterially (IA) will be performed. An isotonic nonionic contrast agent will be used in all cases. Contrast Induced Nephropathy (CIN) is defined as an increase in serum creatinine concentration of 25% or more from the subjects baseline value within a 72-hour period after the administration of contrast media. Serum creatinine concentration will be measured at admission, every day during in-patient hospitalization, and at hospital discharge.

NCT ID: NCT00573898 Completed - Renal Failure Clinical Trials

Daptomycin Study - Collection of Pharmacokinetic Samples in Patients With Renal Failure

Start date: March 2008
Phase: N/A
Study type: Observational

This will be a prospective, multicenter, open-labeled, non-comparative pharmacokinetic study conducted in 10 critically ill, anuric patients receiving CVVHDF. Enrollment will take place at 3-5 clinical sites in the United States. A study coordinator at each site will be identified and institutional specific processes (e.g., pharmacy records, etc.) will be utilized to identify patients. Full evaluation of inclusion and exclusion criteria will be conducted by each site's coordinator within 48 hours of initiation of daptomycin therapy. Subjects receiving daptomycin 6mg/kg (total body weight) once daily for a suspected/documented infection, as deemed necessary by the treating clinician will be screened for inclusion in the current study. Dialysate, ultrafiltrate, and blood flow rate utilized during the CVVHDF procedure will be determined by clinicians at discretion to optimize stability of patients. Daptomycin samples will be obtained around the third dose in an attempt to achieve approximate steady-state concentrations. Pre- and post-filter blood samples will be collected simultaneously with dialysate and ultrafiltrate specimens at multiple time points. Protein binding will be assessed by filtration of the serum samples at the peak drug concentration time points.