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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT02539160 Completed - Clinical trials for Coronary Artery Disease

Impact of Chronic Kidney Disease on the Effects of Ticagrelor in Patients With Diabetes and Coronary Artery Disease

Start date: February 2016
Phase: Phase 4
Study type: Interventional

Patients with diabetes mellitus (DM) are at increased risk of atherothrombotic events. Importantly, DM is a key risk factor for the development of chronic kidney disease (CKD), which further enhances atherothrombotic risk. Clopidogrel is the most widely used platelet P2Y12 receptor inhibitor. However, despite its clinical benefit, patients with DM and CKD frequently experience recurrent atherothrombotic events. Ticagrelor is an oral, reversible, non-competitive P2Y12 receptor inhibitor with more potent and consistent platelet inhibition than clopidogrel. In large-scale clinical investigation, ticagrelor significantly reduced ischemic events to a greater extent than clopidogrel, a finding that was consistent also among DM patients. To date there has been no analysis on the efficacy of ticagrelor in DM patients according to CKD status. Moreover, although pharmacodynamic (PD) studies showed enhanced platelet inhibition associated with ticagrelor, it is unknown how this may be affected by CKD status. Ultimately, how PK/PD profiles of different ticagrelor dosing regimens may be affected by DM and CKD status is also unknown. The proposed study is aimed to show the impact of CKD status among patients with DM and coronary artery disease) CAD on PD and PK profiles of ticagrelor used at 2 doses (90mg bid and 60mg bid) in the setting of a prospective, randomized, cross-over trial.

NCT ID: NCT02533128 Completed - Stroke Clinical Trials

Biomarkers, Blood Pressure, BIS: Risk Stratification/Management of Patients at Cardiac Risk in Major Noncardiac Surgery

BBB
Start date: October 14, 2015
Phase: N/A
Study type: Interventional

Major adverse cardiovascular events (MACE) are a leading cause of serious complications and death following major noncardiac surgery. The heart biomarkers brain-type natriuretic peptide (BNP) and high-sensitivity troponin I/T (hs-TnI/T), may aid in estimating the risk of surgery - low values may permit identifying patients at a very low risk of postoperative complications, potentially helping to avoid unnecessary tests and delays prior to surgery. Recent studies suggest that the manner in which an anesthetic is conducted may have an important impact on postoperative outcomes. The combination of low blood pressure (BP) and a deep level of anesthesia despite a low dose of anesthetic - also known as a "triple low" - has been linked to increased complications and death following surgery. However, it is unclear whether triple lows actually cause postoperative complications or whether they are merely an indicator of a sick patient, who is in general more likely to suffer from cardiovascular events in the near future. To answer this question, in this study patients will be randomly assigned to groups with lower and higher blood pressures, and the postoperative rates of major adverse cardiovascular events and of relevant increases in hs-TnI (a marker of cardiac injury) compared. Another important question is that of the optimal blood pressure target during surgery. Currently there are no established methods of tailoring blood pressure management to the individual patient. In the study the investigators will perform ambulatory 24h BP measurements prior to surgery to measure the patients' average BP during sleep. In the analysis of the study data, the investigators will try to determine the relationship of preoperative biomarker levels, intraoperative BP (both in relation to fixed targets and to the patient's own night-time BP) and of anesthetic depth with the occurrence of major adverse cardiovascular events after surgery.

NCT ID: NCT02523209 Completed - Clinical trials for Chronic Kidney Diseases

Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease (CKD) Candidates for Renal Transplantation

TRANSBONE
Start date: September 2014
Phase: N/A
Study type: Observational

While the duration of renal transplant function has increased over the last decade kidney transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general population. Fracture risk remains increased despite the improvement of immunosuppressive therapies (IST) that allowed the reduction of steroid administration. Potential explanations for this could be 1) that Chronic Kidney Disease (CKD) induces renal osteodystrophy that occurs before kidney transplanted, impairs bone metabolism and promotes bone fragility ; 2) that kidney transplanted patients are older and older (14% of kidney transplanted patients were older than 70 in 2011 in France), ageing being a major risk factor for fractures 3) IST, besides steroid, may have deleterious effects on bone and 4) that secondary hyperparathyroidism, a risk factor of fractures, persists after kidney transplanted . Thus, the pathophysiology and epidemiology of bone fragility of kidney transplanted patient remains insufficiently characterized. Despite these data, and contrarily to what is done for patients candidates for cardiac transplantation, there is no general consensus for performing bone evaluation before kidney transplanted . Thus it's necessary to individualize the management of bone fragility and prevent fractures according to strategies that remain to be defined, provided that patients at risk are better detected.

NCT ID: NCT02521181 Completed - Clinical trials for Chronic Kidney Disease

The BASE Study: Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR)

BASE
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The two doses of sodium bicarbonate being tested are 0.5 and 0.8 mEq/kg-lean body weight (LBW) per day. Sodium bicarbonate, also known as baking soda, may help prevent kidney failure in people with chronic kidney disease. However, the dose to prescribe in order to test this possibility in a clinical trial is uncertain. The BASE pilot clinical trial will help determine the best dose of sodium bicarbonate to prescribe in a future study that will test the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney function in individuals with chronic kidney disease.

NCT ID: NCT02511418 Completed - Hypertension Clinical Trials

Renal Hemodynamic Effects of the HMG-CoA Reductase Inhibitors in Normal Volunteers and in Patients With Chronic Renal Failure

Start date: n/a
Phase: N/A
Study type: Interventional

This study was done to determine whether Simvastatin (a medication commonly used to treat patients with high cholesterol levels in the blood increases blood flow to the kidneys and improves renal function in normal volunteers and patients with impaired renal function secondary to polycystic kidney diseases.

NCT ID: NCT02510274 Completed - Clinical trials for Chronic Kidney Disease

Single and Multiple Dosing Study in Hemodialysis Patients With Hyperphosphatemia in Japan

Start date: May 12, 2014
Phase: Phase 1
Study type: Interventional

The objective of this study is to assess PK, safety and tolerability of a single oral dose of ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d. before or just after each meal

NCT ID: NCT02506868 Completed - Anemia Clinical Trials

Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients

Start date: August 8, 2015
Phase: Phase 3
Study type: Interventional

The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.

NCT ID: NCT02504294 Completed - Clinical trials for Chronic Kidney Disease (CKD)

A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis

Start date: July 13, 2015
Phase: Phase 3
Study type: Interventional

A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.

NCT ID: NCT02504021 Completed - Clinical trials for End-stage Renal Disease

Family Meeting Study for End Stage Renal Disease

Start date: July 2015
Phase: N/A
Study type: Interventional

A randomized clinical trial for patients with end stage renal disease in which a family consultation condition is compared against a treatment as usual control condition on the hospital readmissions after 1 month as the primary outcome variable.

NCT ID: NCT02497300 Completed - Clinical trials for Chronic Kidney Disease

Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease

VEMAKD
Start date: March 2015
Phase: Phase 2
Study type: Interventional

Vascular endothelial dysfunction increases cardiovascular (CV) risk and contributes to the progression of chronic kidney disease (CKD). Mineralocorticoid receptor (MR) antagonists have been shown to improve endothelial function, as well as decrease CV mortality and proteinuria. The specific biochemical pathways that produce these pharmacological effects for MR antagonists, however, are poorly understood. This study investigates the effect of MR antagonism on endothelial function in patients with moderate (stage III) CKD using a randomized, controlled trial. Three specific aims are proposed: Aim 1: To determine if spironolactone improves endothelial function as compared to amiloride in patients with stage III CKD; Aim 2: To determine if oxidative stress is associated with changes in endothelial function by spironolactone compared to amiloride in patients with stage III CKD; and Aim 3: To determine if endothelial dysfunction contributes to albuminuria in patients with stage III CKD. The clinical relevance is to improve understanding of the mechanisms of kidney function decline in CKD in order to develop interventions to delay or prevent dialysis, which would translate into alleviating patient suffering, caregiver burden, and health care costs.