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Kidney Diseases clinical trials

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NCT ID: NCT02373241 Terminated - Hypertension Clinical Trials

Preventing Sickle Cell Kidney Disease

Start date: April 2015
Phase: Phase 2
Study type: Interventional

Untreated hypertension and renal injury are risk factors for increased morbidity and mortality in sickle cell disease, yet early markers of progressive disease have not been identified and therapies to prevent the development of adverse cardiovascular outcomes have not been defined. Circadian blood pressure, as defined by 24 hour blood pressure monitoring, is more accurate than clinic blood pressure in defining secondary hypertension and abnormal nocturnal blood pressured dipping and nocturnal hypertension have been linked to progressive renal disease in other diseases. Methodology/Aims: A randomized feasibility trial of losartan will be conducted among adolescent HbSS and SB0 thalassemia patients (11-19 years) with abnormal nocturnal blood pressure dipping. During this six month feasibility trial, two dosing strategies of losartan (titrated to keep clinic BP <95th percentile vs. <75th percentile) will be analyzed for safety and effect on restoring normal circadian blood pressure. A prospective cohort study among HbSS and SB0 thalassemia patients (6-19 years) will also be conducted to evaluate the incidence of hypertension and role of monitoring potential biomarkers of kidney injury and hypertension. Cohort participants will undergo annual evaluations of hypertension(24 hour blood pressure monitoring for participants ≥ 11yrs, clinic BP in all participants) and markers of kidney injury/hypertension. Expected Results: At the completion of the feasibility trial, vital background information will be obtained to design a definitive multicenter trial of hypertension in sickle cell disease. At the completion of the cohort study, the incidence of pediatric hypertension will be identified and the role for monitoring blood and urine biomarkers will be better understood. As therapy for patients with renal failure is dismal, it is imperative that SCD patients at risk are identified early and that therapeutic trials are conducted that prevent progression.

NCT ID: NCT02369354 Completed - Kidney Disease Clinical Trials

Transplant Social Worker Support for Live Kidney Donation in African Americans

TALKS
Start date: September 2015
Phase: N/A
Study type: Interventional

Talking About Live Kidney Donation Support (TALKS) will study the effectiveness of education, behavior, and financial support interventions to improve consideration of live kidney transplantation/live kidney donation among African Americans on the deceased kidney waiting list. We hypothesize that interventions to help potential kidney transplant recipients and their potential donors overcome barriers to live donor kidney transplant (including family discussions, financial, or logistical barriers) could improve potential recipients' receipt of live kidney transplants. The main outcomes of TALKS will include whether potential recipients (1) have potential live donors call into the transplant center on their behalf; (2) have potential donors evaluated for transplant; or (3) receive a live donor kidney transplant.

NCT ID: NCT02329808 Completed - Kidney Diseases Clinical Trials

Clinical Validation of a Dried Blood Spot Method for Analysis of Immunosuppressives and Antifungals in Pediatrics

PROTECT
Start date: June 2015
Phase:
Study type: Observational

This is a clincial validation study of a dried blood spot (DBS) method for the analysis of immunosuppressive and antifungal agents currently subject of therapeutic drug monitoring (TDM) in a pediatric population. The primary goal is to clinically validate a finger prick DBS method compared to conventional venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the pediatric population. Secondairy goals include feasibility of the finger prick DBS method in the target population, to design an inventory of costs that will be incurred in future health-economic analyses and to construct a population PK model based on the available data collected for the primariy goal.

NCT ID: NCT02325024 Withdrawn - Renal Insufficiency Clinical Trials

A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.

Start date: January 2016
Phase: Phase 1
Study type: Interventional

The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when subjects have severe renal impairment or end stage renal disease (ESRD), compared with subjects who have normal renal function. The primary clinical hypothesis is that there will be an effect from severe renal impairment on the PK of Sativex® when administered as a single oromucosal dose. The study additionally aims to evaluate the safety and tolerability of the same single oromucosal dose of Sativex® in subjects with severe renal impairment or ESRD.

NCT ID: NCT02322073 Recruiting - Obesity Clinical Trials

Inflammation and Obesity-associated Disease

Adipos2
Start date: December 1, 2014
Phase:
Study type: Observational

Visceral obesity and adipose inflammation is considered a driving force of obesity-related systemic disease, e.g. cardiometabolic disease, liver cirrhosis and chronic kidney disease (CKD). Inflammatory resolution is actively regulated by specialized pro-resolving mediators (SPMs), including the endogenous eicosanoid LXA4. Impairment of SPMs may underlie development of obesity-related pathology.We hypothesize that obese patients who develop obesity-related disease do so because they suffer from impaired endogenous production of pro-resolving lipids. This will result in aggravated adipose inflammation and fibrosis, which contribute to the systemic pathologies. We thus wish to investigate adipose inflammation and the pro-resolving lipid profile of obese subjects with and without obesity associated metabolic disease. We also aim to investigate whether LXA4, LXB4 and other anti-inflammatory agents (such as AICAR) can alter the phenotype of human adipose macrophages in ex vivo tissue culture. We also investigate basic pathways in inflammatory regulation and obesity related cardiometabolic disease.

NCT ID: NCT02311010 Active, not recruiting - Kidney Diseases Clinical Trials

Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism

CYRANO
Start date: January 2011
Phase: Phase 4
Study type: Interventional

To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient. The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.

NCT ID: NCT02300376 Completed - Kidney Disease Clinical Trials

Designing a Bayesian Model of the Plasma Clearance of Calcium Edetate de Sodium for the Calculation of GFR and Validity Compared to the Renal Clearance of Inulin

DFGBay
Start date: December 2014
Phase: Phase 3
Study type: Interventional

Diagnosis of patients with renal insufficiency and recommendations for medical treatment of patients who suffer from chronic renal failure are based on the different stages of Glomerular Filtration Rate (GFR). Many formulas exist to assess GFR. However these formulas are unreliable in many clinical situations (old people, obese patients…). Methods for measuring GFR using exogenous tracers exist: Inulin and 51Cr-EDTA are historical reference tracers. Renal clearance of Inulin is the gold standard. However, using these methods is restricted to specialized services because it is long and expensive. There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR. Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a tracer comes from its exclusive elimination by glomerular filtration. Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every included patient during a hospital day care (First visit V1). For transplanted patients, plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less 48hours) during annual medical check-up of renal transplantation (Second visit V2).

NCT ID: NCT02286258 Terminated - Kidney Diseases Clinical Trials

Validation of New Markers of Glomerular Filtration Rate: Dota Gadolinium and Calcium EDTA (MultiGFR)

MultiGFR
Start date: October 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to validate in comparison to a reference method (inuline) two novel non-radioactive biomarkers for glomerular filtration rate (GFR) measurement in chronic-kidney disease (CKD) patients and in healthy volunteers: Calcium-EDTA and Gd-DOTA.

NCT ID: NCT02276950 Active, not recruiting - Depression Clinical Trials

HeAlth-data Register sTudies of Risk and Outcomes in Cardiac Surgery

HARTROCS
Start date: January 2011
Phase:
Study type: Observational

The overall project aim is to study risk and outcomes following cardiac surgery by cross-linking high-quality national Swedish health-data registers for population-based investigations of individual level clinically relevant patient data.

NCT ID: NCT02263833 Completed - Clinical trials for Kidney Disease, Chronic

An Observational, Prospective, Safety Study of Mircera (Monopegylated Epoetin Beta) in Clinical Practice

Start date: September 2009
Phase: N/A
Study type: Observational

This national study was a post-marketing surveillance study conducted in Korea from 29 August 2008 to 28 August 2012 to meet local regulatory requirements for Mircera (monopegylated-epoetin beta). Prospective patient-based data collection was evaluated for safety/risk assessments and effectiveness. No specific study-related procedures are required. Patients were to be followed up as long as possible at the physician's discretion.