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34 active trials for Renal Insufficiency

Product Surveillance Registry

The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Start: January 2012

HOLT-ED: Holter-monitoring in End-stage Renal Disease

The main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.

Start: September 2021

A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in adult participants with renal impairment compared with healthy participants with normal renal function.

Start: August 2020

A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems

Pevonedistat is a medicine to treat people with blood cancers or solid tumors. The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have severe kidney problems or mild to moderate liver problems. The information from this study will be used to work out the best dose of pevonedistat to give people with these conditions in future studies. At the first visit, the study doctor will check who can take part in the study. This study is in 2 parts: A and B. Part A Participants will be placed into 1 of 4 treatment groups depending on how severe their kidney and liver problems are. All participants will receive 1 dose of pevonedistat as a slow injection in their vein (infusion). Then, the study doctors will check the levels of pevonedistat in the blood of the participants for 3 days after the infusion. They will also check if the participants have any side effects from pevonedistat. Participants will be asked to continue to Part B. Those who don't want to continue will visit the clinic 30 days later for a final check-up. Part B Participants who agree to participate into Part B will receive an infusion of pevonedistat on specific days during a 21-day or 28-day cycle. The cycle time will depend on what type of cancer the participants have. Participants will also be treated with standard of care medicines for their kidney and liver problems during this time. In the first cycle, the study doctors will also check the levels of pevonedistat in the blood and urine of participants for 3 days after the infusion. Participants will continue with cycles of treatment together with standard of care medicines until their condition gets worse or they have too many side effects from the treatment. When treatment has finished, participants will visit the clinic 10 days later for a final check-up.

Start: July 2019

Pirfenidone Capsule in Patients With Chronic Kidney Disease G2 and G3a Study on Safety and Pharmacokinetics

To evaluate the safety and pharmacokinetic characteristics of pirfenidone capsules in chronic kidney disease G2 and G3a patients, and to provide a basis for the phase II clinical trial program

Start: August 2019

Renal Involvement in Hospitalized Children With COVID-19

Covid-19 is an important human and animal pathogen, it mostly causes respiratory and gastrointestinal symptoms. Clinical features range from a common cold to severe diseases such as severe acute respiratory distress syndrome, bronchitis, pneumonia, multi-organ failure, and even death. It seems to be less commonly affecting children and to cause fewer symptoms and less severe disease in this age group compared with adults. Clinicians have observed many extrapulmonary manifestations of COVID-19, as hematologic, cardiovascular, renal, gastrointestinal and hepatobiliary, endocrinologic, neurologic, ophthalmologic, and dermatologic systems can all be affected. This retrospective study that will be conducted at Hamad General Hospital in Qatar, aims to determine the renal involvement in all pediatric patients who were hospitalized with COVID-19 from March 1, 2020, to January 1, 2021.

Start: March 2021

Transcatheter Implantation of Aortic Bioprosthesis Without the Use of Iodinated Contrast in Patients With Chronic Kidney Disease

Acute renal failure (ARF) after transcatheter aortic valve implantation (TAVI) is a frequent complication, with significant clinical consequences. History of chronic kidney disease and the use of a large amount of iodinated contrast for planning and procedure are among the main risk factors for the development of this complication. The present study aims to: (1) define the role of non-contrast imaging modalities in pre-procedure planning; (2) evaluate the feasibility and safety of a new TAVI technique without using iodinated contrast; (3) to determine the incidence of acute renal failure in patients with aortic stenosis and chronic kidney disease undergoing TAVI, using the new technique without contrast. The study will be divided into two stages. In the pilot phase, 25 consecutive patients with chronic kidney disease (stage ? 3a) will have the TAVI planning and procedure performed without the use of iodinated contrast, but with all the steps subjected to verification by the standard technique, to ensure the safety of the patient. The occurrence of the combined primary safety outcome composed of adverse clinical events within 30 days (defined by the VARC-2 criteria) in less than 20% of cases will be used to define the continuity of the study. In the second phase, 50 patients with chronic kidney disease stage ? 3b will be submitted to TAVI with the "zero contrast" technique. The primary outcome assessed at this stage of the study will be the incidence of AKI within 7 days after TAVI using the new technique in this high-risk population.

Start: December 2020

TDF Dose Adjustment VS. Switching to TAF in TDF-experienced CHB Patients With Renal Impairment

Tenofovir is a nucleotide analog drug that works against both Human immunodeficiency virus (HIV) and HBV. TDF and TAF are prodrug of Tenofovir. TAF has a higher plasma stability than TDF, which makes TDF require a higher dose to get the concentration of drugs in the liver equal to the amount of TAF. Previous studies have shown the effects of TAF once daily and TDF once daily on kidney function and bone mass. The efficacy of TAF in virus suppression is comparable to TDF, but the effect on the kidneys and bone mass from TAF has less side effects than TDF. In addition, changing the medication from TDF to TAF shows that kidney function tends to improve. Hepatitis B patients taking TDF have adjusted their dosage due to impair renal function, for example, from 1 time per day to every 48 hours or every 72 hours. This group of patients does not have a clear evidence-based recommendation for choosing a reduced dose of TDF or change to TAF. Therefore, the main objective of this study is to study patients with hepatitis B who have taken TDF and have renal function impairment that have been adjusted. Taking the same medicine with dose adjustment or changing the drug to TAF which treatment will more improve the kidney function.

Start: November 2019

Sonographic Examination of Renal Function in Individuals With Long-term Spinal Cord Injury

Patients with long-term lower urinary tract dysfunction due to spinal cord injury presenting for a routine urodynamic control will be screened for inclusion and exclusion criteria. Suitable individuals providing written informed consent will undergo renal Doppler sonography and renal scintigraphy in addition to the routine examinations. Conclusions regarding renal function based on the clearance rate determined by scintigraphy (gold standard) will be compared with the conclusions based on Doppler sonography and Cystatin C clearance.

Start: August 2021

Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast

Point-of-care (POC) creatinine devices allow rapid measurement of creatinine levels and calculation of estimated glomerular filtration rate (eGFR) which give an indication of renal function. The focus of this assessment is to validate POC measurements to assess kidney function before intravascular iodinated contrast administration in patients with severe renal insufficiency (eGFR < 30 ml/min/1.73m2). It will be evaluated whether discrepancies between POC measurement values and values obtained from standard laboratory assays lie within an acceptable range using Bland-Altman analysis.

Start: May 2021

Time to Excretion of Contrast, a Maastricht Prospective Observational Study

Risk of contrast-induced kidney injury is expected to be strongly correlated with exposure time. Studies on the excretion of iodinated contrast material are few and have mostly been carried out in patients with normal renal function. Although case wise reports of persistent renograms have been published, it is not known how long contrast is retained before excretion in patients with eGFR <30 mL/min/1.73m2, nor which of these patients are most susceptible to contrast retention. The current observational study aims to compare contrast elimination time and % contrast excretion in patients with eGFR <30 mL/min/1.73m2, to matched patients (for age, sex and contrast procedure type) with eGFR 30-59 and eGFR >=60 mL/min/1.73m2.

Start: November 2021

Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30

Intravascular iodinated contrast administration has become crucial to modern medicine. Currently it is estimated that over 250 million injections are given each year worldwide during medical scans and interventions. An acute predefined increase in serum creatinine is considered an indicator of acute kidney injury (AKI). When such an acute increase in serum creatinine occurs within 5 days post-contrast in absence of another aetiology, it is assumed to be iodinated contrast administration induced acute kidney injury. For over 50 years now, acute kidney injury caused by intravascular administration of iodinated contrast material has been considered a leading cause of hospital-acquired renal failure. Contrast has been withheld in fear of kidney injury with misdiagnoses and delayed appropriate patient management as a result. Since 2018, it is now widely accepted that only patients with eGFR <30 mL/min/1.73m2 are at risk of renal injury after intravascular iodinated contrast material injection. However, no study to date has been able to distinguish acute kidney injury caused by iodinated contrast administration from that for which no causal link is established, and it is unsure a causal relationship exists. There are several studies, in attempts to evaluate the causal relationship between contrast exposure and nephrotoxicity, that found fluctuations in absence of contrast similar to those considered to be contrast-induced acute kidney injury. Similarly, it is unsure whether longer-term negative outcomes are inherent to the population studied or a result of contrast administration. However, most of these studies are observational and retrospective in nature. The issue with retrospective studies is that they often cannot control for confounders and therefore cannot give us causation, only association. On the other hand, prospective randomized controlled trials comparing intravascular iodinated contrast administration to no contrast are unlikely given evident ethical issues. The current prospective observational study proposes to use intra-patient comparisons of peak change in renal function during periods in absence of- and with contrast to elucidate the relationship between renal function and contrast administration in this population.

Start: November 2021

Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm

This randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm (AAA) with stentgrafts either with active supra- or infrarenal fixation.

Start: April 2021

The Effect of Three Endourological Procedures for the Management of Renal Calculi Regarding Acute Kidney Injury

The main aim of the study is to investigate and compare the possible acute effect of standard PCNL, mini-PCNL and RIRS on renal function. Secondary aims are to investigate the efficacy (stone-free rate), safety (complication rate, long-term kidney function) and other parameters (operation, fluoroscopy and hospitalization time) concerning the 3 endourological operations (PCNL, mini- PCNL, RIRS) for the treatment of renal calculi.

Start: June 2018

Telmisartan Versus Enalapril in Heart Failure With Reduced Ejection Fraction Patients With Moderately Impaired Kidney Functions

Heart Failure (HF) poses a major health burden in various populations, with devastating annual rates of morbidity and mortality. It is estimated that 1%-to-2% of the general population suffer from the heart failure syndrome. HF with reduced ejection fraction (HFrEF) is the most studied among different strata of ejection fractions (compared to HFpEF and HFmrEF), and thus therapies with evidence based survival benefit are well identified. The syndrome of heart failure and the subsequent reduced cardiac output triggers activation of neurohormonal compensatory responses aiming to augment cardiac output and tissue perfusion, like upregulation of sympathetic nervous system and over-activation of the Renin Angiotensin Aldosterone System. Nevertheless, overshooting of such compensatory mechanisms have deleterious effects on heart failure in terms of aggravation of symptoms and reduction of survival. Angiotensin II acts primarily on type I receptors inducing the following: intense arteriolar vasoconstriction stimulates sodium reabsorption in the proximal convoluted tubules stimulates adrenal medulla to secrete catecholamines stimulates sympathetic nervous system, through facilitation of ganglionic stimulation modestly inhibits vagus (parasympathetic system) stimulates secretion of vasopressin/anti-diuretic hormone stimulates adrenal cortex to secrete aldosterone, which promotes sodium and water reabsorption and promotes potassium secretion at the distal convoluted tubules in addition to induction of myocardial remodeling and fibrosis constricts the glomerular efferent arteriole which increase filtration pressure and promotes proteinuria and nephron injury/loss. While, angiotensin type II receptors activation have beneficial effects like vasodilatation and promoting endothelial function. Accordingly, angiotensin converting enzyme inhibitors (ACEi), angiotensin-II receptor type I blockers (ARBs) or Angiotensin receptor blocker- neprilisin inhibitor (ARNI) are considered a cornerstone in HFrEF therapy for both: symptoms relief and improvement of survival. Yet, hypotension, hyperkalemia or worsening of renal function are potential side effects that occasionally may lead to ACEi/ARBs/ARNI intolerance and subsequent discontinuation with loss of their cardioprotective effects. On the other hand, cardiorenal syndrome is a recently introduced medical category due to the frequent association of cardiac and renal dysfunction in clinical practice. CardioRenal Syndrome CRS type I; acute cardiac dysfunction leading to renal dysfunction, is reported in 25%-to-33% of acute heart failure patients, and this prevalence jumps to 70% in cases of cardiogenic shock. CRS type II; chronic cardiac dysfunction leading to renal dysfunction, was found in 45% of chronic heart failure patients. Despite the definite renoprotective and antiproteinuric effects of RAAS blockade in patients with chronic renal impairment, in cases when the glomerular filtration is critically dependent on angiotensin II-mediated efferent vasoconstriction such as in patients with heart failure and severe depletion of circulating volume-, ACEi/ARBs can lead to profound reduction of the glomerular filtration rate (GFR). The concerns about the safety of RAAS blockade in the presence of renal impairment has led to profound underutilization of these drugs in CHF patients with renal impairment. The very prevalent co-existence of heart failure and renal impairment prominently impairs patients' outcomes both by direct disease effects and indirectly due to the occasional but frequent enforced discontinuation of therapies with proven survival benefit.[6] Telmisartan is an ARB with peculiar pharmacodynamic properties. Unlike most of the ACEi/ARBs family, Telmisartan primarily depends on hepatic excretion and only a minority depends on renal excretion. Telmisartan has been proved in human and animal studies to be an effective agonist of the peroxisome proliferator-activated receptor gamma (PPAR ?) which potentiates its renoprotective effects being acting by dual mechanism. So, it can be hypothesized that Telmisartan might be better tolerated than standard ACEi/ARBs in HF patients with moderate renal impairment, guranteeing less frequent interruptions and more consistent cardioprotective and renoprotective effects. However, there is no wealth of data to support or deny this theory.

Start: February 2021

Hemofilter Life Span, ECLS and/or CRRT

The goal of this project to better understand the immune-modulatory effects of continuous renal replacement therapy (CRRT) in neonatal and pediatric patients, particularly those receiving extracorporeal life support (ECLS). Little is known about the effects of CRRT in this particular population and improved knowledge will be useful clinically and may lead to novel therapeutic approaches and improved outcomes for these critically ill patients.

Start: January 2020

Evaluation of Macro and Microcirculatory Arterial Condition of the Upper Limb in Insufficiently Renal Patients

Evaluation of macro and microcirculatory arterial condition of the upper limb in insufficiently renal patients Hand ischemia affects 1.6 to 8% of patients with arteriovenous fistula (FAV) of hemodialysis in the upper limb. The diagnostic and therapeutic stakes are major as it concerns the functional prognosis of the hand and, to a lesser extent, vascular access for hemodialysis. In some cases, the diagnosis of ischemic hemo-hijacking is evident, in other cases, the ischemic condition appears to be rather the result of uncompensated arteriatory of the upper limb or limbs. Echo-doppler exploration is usual for assessing vascular access but without validated formal criteria for arterial disease in the upper limbs, with fistula flow calculation and analysis of FAV hemodynamics. Compression manoeuvres on or under the FAV can also be performed. The pressures of the digital arteries are also indicated with non-consensual values found in the literature for the diagnosis of digital ischemia but with varying tools in terms of collection of measurements. The main objective of this study is to collate the characteristics of arterial condition of the upper limbs of medium or severe renal patients, medium- or short-term candidates for kidney dialysis. The data collected will match the data of the arterial echodoppler as well as measures of pressures doppler laser and plethysmography. Candidates for dialysis tend to be older and polyvascular. A better assessment of the vascular condition of their upper limbs, including the diagnosis of advanced arterial disease, could eventually guide the choice of type of dialysis (compared to an indication of FAV).

Start: June 2020

Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality

With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes. Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

Start: February 2017

Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment

Study Type and Design Prospective, Observational Study Rivaroxaban in Elderly AF patients with or without renal impairment in Korea This study will investigate effectiveness and safety in elderly patients, the result from well-designed and high-quality prospective clinical registry collected through real-world clinical practice is expected to resolve current medical unmet needs of rivaroxaban in Korean elderly patients. Primary Study Objective(s) To investigate the effectiveness of rivaroxaban in elderly patients with NVAF, with or without renal impairment in Korea real-world clinical practice settings Secondary Study Objective(s) To see safety outcome including major bleeding, clinically non-major bleeding, all-cause mortality rivaroxaban in subgroup based on risk factor(eg. Renal impairment) physicians' treatment pattern in rivaroxaban

Start: September 2019

Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants

In renally impaired patients with acute venous thromboembolism (VTE), standard-of-care (SOC) anticoagulation, i.e. heparins-vitamin K antagonists (VKA), at therapeutic dosage is associated with an increased risk of thromboembolic and bleeding complications compared to patients with normal renal function. Direct oral anticoagulants (DOAs) have been shown to be at least as effective and safe as SOC in VTE treatment. But in the clinical trials, moderate renally impaired patients were poorly represented and patients with severe renal insufficiency not at all. So no dose reduction was considered. Surprisingly, DOAs have been approved for VTE treatment in moderate and severe renally impaired patients. There is need to evaluate a reduced dose of DOAs for VTE treatment in patients with moderate and severe renal insufficiency. We plan to evaluate reduced doses of 2 DOAs (apixaban, rivaroxaban) compared to SOC in VTE patients with moderate or severe renal insufficiency in terms of net clinical benefit (recurrent VTE and major bleeding) at 3 months.

Start: October 2016