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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT02967042 Recruiting - Clinical trials for Chronic Kidney Disease

Chronic Kidney Disease and Bone - Correlation Between 18F-PET-TT Imaging and Histomorphometry of Bone in CKD Patients

CKD-Bone
Start date: December 17, 2016
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) is an increasing public health problem and the number of patient with chronic kidney disease is increasing worldwide. Bone abnormalities are found almost universally in patients with CKD requiring dialysis and in the majority of patients with CKD stages 3-5. Chronic kidney disease-mineral bone disorder (CKD-MBD) is a complex disorder of bone and mineral metabolism, which is associated with disorder in circulating levels of hormones and development of secondary hyperparathyroid disease. The abnormalities of mineral homeostasis impair bone remodeling and mineralization and results in cortical and trabecular defects and an increased fracture risk. There is also an association with increased morbidity and mortality. CKD-MBD is also associated with development of calcification of the blood vessels. During the last decade it has been increasingly acknowledged that mineral and bone disorder contribute to the excessively high cardiovascular morbidity and mortality in patients with chronic kidney disease. The diagnosis of mineral bone disorder and the underlying bone histology in CKD patients is challenging. The treatment of renal osteodystrophy (ROD) and especially the treatment of fractures in this patient group, depends on the underlying bone histopathology and bone turnover. The gold standard for diagnosing the subtypes of ROD is bone biopsy, but it is invasive and requires considerable expertise regarding quantitative histomorphometry and interpretation. Plasma parathormone (PTH) measurement is commonly used to evaluate these patients, and generally extremely high or low PTH levels predict the underlying bone disorder. Still PTHs ability to correctly estimate turnover in bone is limited. Several biomarkers such as tartrate-resistant acid phosphatase 5b (TRAP5b) and procollagen type 1 N-terminal propetide (PINP) has been investigated, but no biomarker in clinical use has yet been proven suitable or superior to PTH to estimate overall bone histology. 18F-NaF positron emission tomography (18F-NaF PET) is a noninvasive quantitative imaging technique that allows assessment of regional bone turnover at clinically relevant sites. 18F-NaF is a bone-seeking tracer, which reflects remodeling of bone and osteoblast activity25. 18F-NaF serves as an efficient tracer to measure metabolic changes in bone. A correlation between histomorphometric markers such as bone formation rate (BFR) and tracer activity in the 18F- NaF PET scan in CKD patients has previously been shown in one small study. This study`s goal is to evaluate, if 18-NaF-Positron emission tomography-computed tomography (18F-PET-TT) can be used in the assessment of CKD patients. The hypothesis is that 18F-PET-TT correlates with the histomorphometry of bone biopsy and with the calcification score in CKD patients and that 18F-PET-TT maybe can be used as a diagnostic imaging technique in the future.

NCT ID: NCT02966717 Active, not recruiting - Clinical trials for Renal Insufficiency, Chronic

Rituximab Combined With MSCs in the Treatment of PNS (3-4 Stage of CKD)

CKD
Start date: August 2016
Phase: Phase 2
Study type: Interventional

Primary nephrotic syndrome(PNS) is a group of clinical symptoms caused by a variety of factors, including immune,environmental, genetic, et al. Oral corticosteroids have been to be the preferred drug for the treatment of PNS, but the long-term use of glucocorticoid therapy in clinic often induces some problems such as hormone dependent and hormone resistance, as well as severe side effects which act as a threat to the patients' health. Besides, patients with proteinuria long-term not control often behave faster progression into chronic renal failure, leading to poor prognosis. In renal diseases, Rituximab ( RTX) is often used in the treatment of refractory nephropathy, such as hormone dependent nephrotic syndrome, hormone resistance nephrotic syndrome, frequency recurrence nephrotic syndrome, which shows exciting effects in delaying the development of the disease.At present, mesenchymal stem cells ( MSCs) has been used as a research hotspot to repair the tissue damage of chronic kidney disease, and it also behaves certain effects. The purpose of this study is to seek a more targeted treatment, more precise curative effect and more feasibility treatment for PNS(CKD3-4),so as to delay or reverse the disease and improve the quality of life of patients with CKD.

NCT ID: NCT02965053 Completed - Hyperphosphatemia Clinical Trials

A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

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

This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789 and its combination with sevelamer carbonate are tested in Period 1 and Period 2 respectively.

NCT ID: NCT02964936 Completed - Clinical trials for Chronic Kidney Disease

A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia

Start date: January 11, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.

NCT ID: NCT02964546 Terminated - Atrial Fibrillation Clinical Trials

Glomerular Filtration Rate-Estimating Equations During Use of Direct Oral Anticoagulants in Elderly Patients

REINACO
Start date: June 8, 2015
Phase:
Study type: Observational

Atrial fibrillation in the elderly is a complex condition due to the high number of frequently associated comorbidities such kidney disease. Direct oral anticoagulants (dabigatran, rivaroxaban and apixaban) are indicated for preventing thromboembolic events but renal function should be closely monitored for this age group when these drugs are used. Dosing recommendations for prevention of stroke are based on renal clearance of creatinine (ClCr) estimated using the Cockcroft-Gault formula. It is well known that ClCr estimates predict a steeper decline with advancing age than Glomerular Filtration Rate (GFR) estimates. This raises the possibility that substitution of commonly reported GFR for estimated CrCl could result in different plasmatic concentrations of oral direct anticoagulants. The aim of this study was to compare estimates of ClCr and GFR and determine the impact on the plasmatic concentration of these drugs in elderly patients with non-valvular atrial fibrillation.

NCT ID: NCT02964429 Completed - Clinical trials for Kidney Insufficiency

Determination In-vivo KUF for Diacap Pro Hemodialyser

Start date: November 14, 2016
Phase: N/A
Study type: Interventional

The main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo KUF) for Diacap Pro dialyzers following routine dialysis prescription in the United States.

NCT ID: NCT02957864 Recruiting - Hiv Clinical Trials

Switching From Tenofovir Disoproxil Fumarate to Abacavir or Tenofovir Alafenamide

BACTAF
Start date: October 2016
Phase: Phase 4
Study type: Interventional

Tenofovir disoproxil fumarate (TDF) is one of the most frequently used drugs to treat HIV. Long term use of TDF can induce renal toxicity. Tenofovir alafenamide (TAF) is a new pro-drug of Tenofovir which has not been associated with renal toxicity and may therefore be a good substitute for TDF in patients with TDF induced renal toxicity. Abacavir (ABC) is another drug that can be used for the treatment of HIV and is not associated with renal toxicity. In this study the investigators will compare the effect on renal function of a switch from TDF to TAF with a switch from TDF to ABC in patients with TDF induced renal insufficiency.

NCT ID: NCT02952092 Completed - Clinical trials for Hemodialysis Chronic Kidney Disease Patients With Anemia

A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia

Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.

NCT ID: NCT02950142 Completed - Obesity Clinical Trials

Evidence-based Laboratory Test Order Sets in Primary Care

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

Cluster randomised controlled trial to evaluate what the effect is of evidence-based order sets aimed at five indications on the appropriateness of laboratory test ordering in primary care.

NCT ID: NCT02947750 Recruiting - Clinical trials for Renal Insufficiency, Chronic

Neurovascular Transduction During Exercise in Chronic Kidney Disease

NeurovEx
Start date: October 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and to explore what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate). This study will also test whether or not regular exercise on a bicycle and/or treatment with 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplementation improves these measures during exercise. 6R-BH4 is currently FDA-approved for use in patients with certain forms of a disease called phenylketonuria, but it is not currently FDA approved for blood pressure or exercise capacity in people with CKD.