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Renal Insufficiency clinical trials

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NCT ID: NCT04451018 Recruiting - Renal Insufficiency Clinical Trials

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

SYSTOE-HAIDI
Start date: June 17, 2020
Phase:
Study type: Observational

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).

NCT ID: NCT04447911 Recruiting - Kidney Failure Clinical Trials

Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia

EMPOWER
Start date: February 4, 2021
Phase: Phase 4
Study type: Interventional

Hyponatremia is the most common electrolyte derangement occurring in hospitalized patients. It is usually classified as hypovolemic, euvolemic or hypervolemic. The most common aetiology of euvolemic hyponatremia is the syndrome of inappropriate antidiuresis (SIAD). Hypervolemic hyponatremia is common in patients with congestive heart failure (CHF) (10-27%) and liver cirrhosis (up to approximately 50%). In SIAD, the regulation of arginine vasopressin (AVP) secretion is impaired which leads to free water retention. In CHF and liver cirrhosis, the effective arterial blood volume is decreased leading to non-osmotic baroreceptor mediated AVP release and consecutive free water retention. Current treatments of euvolemic and hypervolemic hyponatremia, including the most used treatment fluid restriction, are of limited efficacy. Sodium-Glucose-Co-Transporter 2 (SGLT2) inhibitors reduce glucose reabsorption in the proximal tubule, resulting in glucosuria and consecutive osmotic diuresis. A placebo-controlled randomized trial of our group has shown that a short-term, i.e. a 4-days administration of the SGLT2 inhibitor empagliflozin (Jardiance)® in addition to fluid restriction was effective in increasing the serum sodium concentration in 87 patients with SIAD-induced hyponatremia. The effect of empagliflozin (Jardiance)® without additional fluid restriction is however not yet known. Large randomized controlled trials have shown that SGLT2 inhibitors reduced hospitalization for heart failure in patients with, and more recently without type 2 diabetes. No studies have investigated the effect of SGLT2 inhibitors in hypervolemic hyponatremia. To evaluate the effect of empagliflozin (Jardiance)® in eu- and hypervolemic hyponatremia, a randomized placebo-controlled study is needed.

NCT ID: NCT04446858 Recruiting - Clinical trials for Kidney Failure, Acute

Non-invasive Evaluation of the Predictive Value of CEUS and SWE in ACLF, Renal Failure and Hepatorenal Syndrome

NECTAR
Start date: January 1, 2021
Phase:
Study type: Observational

Evaluation of non-invasive prognostic parameters in patients developing ACLF and renal failure in patients receiving and not receiving transjugular intrahepatic portosystemic shunt (TIPS). Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

NCT ID: NCT04446507 Recruiting - Renal Impairment Clinical Trials

A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects With Severe Renal Impairment and Normal Renal Function

Start date: July 27, 2020
Phase: Phase 1
Study type: Interventional

This will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.

NCT ID: NCT04445779 Recruiting - Acute Kidney Injury Clinical Trials

Q10 Preloading Before Cardiac Surgery for Kidney Failure Reduction

PREKARKID-10
Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Coenzyme Q10 (CoQ10) is an essential molecule in human body. It acts as an antioxidant, a co-factor for energy conversion in mitochondria and has anti-inflammatory effects capable of improving endothelial function. Our goal is to investigate whether CoQ10 is capable to reduce the incidence of acute kidney injury/failure following cardiac surgery. Cardiac surgery is major risk factor for acute kidney injury/failure (AKI/F).

NCT ID: NCT04398745 Recruiting - Multiple Myeloma Clinical Trials

A Study of Belantamab Mafodotin Monotherapy in Multiple Myeloma Participants With Normal and Varying Degree of Impaired Renal Function

DREAMM12
Start date: October 9, 2020
Phase: Phase 1
Study type: Interventional

Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and the majority of MM participants is either at risk or already has renal dysfunction at initial diagnosis. The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with RRMM, who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation ) and have either normal or impaired renal functions. The study will consist of two parts: part 1 will include participants with normal/mildly impaired renal function and severe renal impairment and part 2 will include participants with end-stage renal disease (ESRD), where participants are either not undergoing or require hemodialysis. Participants will be administered belantamab mafodotin at a dose of 2.5 milligram per kilogram (mg/kg) intravenously once in three weeks (Q3W) dosing in Part 1. Based on the Part 1 Safety/Pharmacokinetic (PK) data, Part 2 participants will be administered the dose of either 2.5 mg/kg or 1.9 mg/kg (or other adjusted dose). Participants will be treated with belantamab mafodotin monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase, follow-up phase and a post analysis continued treatment (PACT) phase . The total duration of the study is approximately up to 48 months.

NCT ID: NCT04391608 Recruiting - Renal Insufficiency Clinical Trials

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

Start date: November 9, 2019
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04367714 Recruiting - COVID Clinical Trials

Antibody Response Against SARS-CoV-2 in Dialysis Patients During COVID-19

COVCKD
Start date: March 15, 2020
Phase:
Study type: Observational [Patient Registry]

Determination of IgM and IgG antibodies against SARS-CoV-2 in dialysis patients by continous monitoring in the period from March 2020 to december 2020

NCT ID: NCT04334707 Recruiting - Clinical trials for Chronic Kidney Diseases

Kidney Precision Medicine Project

KPMP
Start date: September 1, 2019
Phase:
Study type: Observational

Acute kidney injury (AKI) and chronic kidney disease (CKD) impose a significant global health burden. Yet, no effective therapies currently exist for AKI, and only a few are available for CKD. Despite significant effort from industry and academia, development of pharmacologic therapies for AKI and CKD has been hampered by: Non-predictive animal models The inability to identify and prioritize human targets The limited availability of human kidney biopsy tissue A poor understanding of AKI and CKD heterogeneity Historically, AKI and CKD have been described as single, uniform diseases. However, growing consensus suggests that different disease pathways lead to different subgroups of AKI and CKD (AKIs and CKDs). Access to human kidney biopsy tissue is a critical first step to define disease heterogeneity and determine the precise molecular pathways that will facilitate identification of specific drug targets and ultimately enable individualized care for people with AKI and CKD. A number of research centers across the United States are collaborating to bring state-of-the-art technologies together to: - Ethically obtain and evaluate kidney biopsies from participants with AKI or CKD - Define disease subgroups - Create a kidney tissue atlas - Identify critical cells, pathways, and targets for novel therapies The KPMP is made up of three distinct, but highly interactive, activity groups: - Recruitment Sites: The recruitment sites (RS) are responsible for recruiting participants with AKI or CKD into the longitudinal study and performing the kidney biopsy. - Tissue Interrogation Sites: The tissue interrogation sites (TIS) are responsible for developing and using innovative technologies to analyze the biopsy tissue. - Central Hub: The central hub is responsible for aggregating, analyzing, and visualizing the generated data and providing scientific, infrastructure, and administrative support for the KPMP consortium.

NCT ID: NCT04331132 Recruiting - Acute Heart Failure Clinical Trials

Tolvaptan add-on Therapy to Overcome Loop Diuretic Resistance in Acute Heart Failure With Renal Dysfunction

DR-AHF
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Renal dysfunction, which comprises 10%-40% of acute heart failure patients (AHF), plays an important role in diuretic resistance mechanism. DR-AHF was designed to demonstrate the effectiveness of early tolvaptan (a vasopressin-2 receptor antagonist) add-on therapy in acute heart failure patients with renal dysfunction and clinical evidence of loop diuretic resistance.