
Diffusion Weighted Magnetic Resonance Imaging in Chronic Kidney Disease
Renal DiseaseChronic kidney disease (CKD) is a common global public health problem and the average incidence of end-stage renal disease in developing countries is 150 per million population, which is lower than that in the developed world

Chronic Kidney Disease and Bone - Correlation Between 18F-PET-TT Imaging and Histomorphometry of...
Chronic Kidney DiseaseChronic 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.

Study of the Bioaccumulation of Tinzaparin in Renally Impaired Patients When Given at Prophylactic...
Renal InsufficiencyChronic2 moreThe purpose of this study is to assess if accumulation of anti-Xa activity occurs after repeated daily administration of prophylactic doses of tinzaparin in patients with severe chronic kidney disease (CKD) requiring thromboprophylaxis for non-surgical conditions. It is anticipated that tinzaparin used at a fixed dose for thromboprophylaxis in severe CKD patients (eGFR ≤ 30 ml/min /1.73 m2) at risk for venous thromboembolism (VTE) will not bioaccumulate at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level between day 2 or 3 and day 5.

Urotensin II in Chronic Kidney Diseases and Kidney Transplants
Chronic Renal DiseaseThe investigators are planning to study the serum level of Urotensin II in chronic kidney disease patients, kidney transplants, and healthy controls.

Observational Study of Kibow Biotics in Chronic Kidney Failure Patients on Dialysis
Chronic Kidney DiseaseA specifically formulated probiotic product comprised of defined and tested microbial strains may afford renoprotection in what has been generally called "Enteric DialysisTM". However, it is also referred to as enteric toxin reduction technology. Our hypothesis is to assess the potential benefits in devising a bowel-based probiotic formulation (Kibow® Biotics/RenadylTM) as a dietary supplement product for patients undergoing dialysis along with standardized care of treatment.

Renal Nerve Ablation in Chronic Kidney Disease Patients
HypertensionChronic Kidney DiseaseIn patients with treatment resistent hypertension renal nerve ablation emerged as an effective interventional approach of treating hypertensive disease with a progressively increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is one of the major underlying pathogenetic mechanism of the fall in blood pressure but the precise mechanisms that causes the fall in blood pressure in the short-term and, in particular, long-term remains elusive. The objective of the study is to understand the pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic nervous system. In 100 hypertensive patients most advanced technology will be applied, before and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labelling technique), local activity of the renin angiotensin system in the kidney (urinary angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24 hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall in blood pressure after renal denervation may help to identify those hypertensive patients that profit most from renal nerve ablation in terms of blood pressure reduction. The investigators propose the following hypotheses why a progressive decrease in blood pressure happens, in addition to the decreased activity of the central nervous system, after renal nerve ablation: Short term effects: A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the kidney C)Exaggerated sodium excretion immediately after renal nerve ablation Long term effects: D)Decrease of total sodium content after 6 and 12 months. E)Improvement of vascular wall properties after 6 and 12 months

An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic...
Kidney DiseaseChronicThis observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.

Salivary Phosphorus and Level of Kidney Function
Chronic Kidney DiseaseThe specific purpose of this study is to describe the relationship between salivary phosphorus and kidney function, specifically as it relates to serum phosphorus, FGF23, PTH, vitamin D status and urinary excretion of phosphorus.

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
AdenovirusAnesthesia57 moreUnderstudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

Comparison of Markers of Kidney Function
Chronic Kidney DiseaseRenal InsufficiencyGlomerular filtration rate (GFR) is the best known measurement of kidney function. Serum creatinine (blood test) is the most commonly used marker to predict GFR. It is a convenient, inexpensive test that involves a single blood draw with rapid results. However, creatinine has several limitations because its blood level is dependent on age, body mass, and sex. One of the gold standards for measuring GFR is plasma clearance of an IV injected agent, iohexol. It has been found to be safe and nontoxic in prior studies, but is not practical in the clinical setting due to the need for several timed blood draws. Recent studies have investigated the use of cystatin C as an alternative marker to predict GFR. Cystatin C also involves only a single blood draw, and has less confounding factors than creatinine since it is independent of age, body mass, and sex. Currently, it remains controversial whether cystatin C is a significantly better biomarker of estimated GFR than creatinine. To date, there has not been a large prospective cohort study to compare cystatin C and creatinine in pediatric kidney transplant patients who are on maintenance immunosuppression (anti-rejection drugs). Accurate measurement and early detection of deterioration of GFR is critical in the care of this patient population. The purpose of this study is to assess the accuracy of estimating GFR by using cystatin C versus creatinine clearance equations when compared to the surrogate gold standard of iohexol GFR in pediatric renal transplant patients.