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Renal Insufficiency clinical trials

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NCT ID: NCT04195126 Not yet recruiting - Burns Clinical Trials

Early Haemadsorption in Major Burns

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Major deep burns (>20% body surface, involving deep skin layers) and associated severe inflammatory reaction and their complication are one of the biggest challenge of intensive care. Haemoadsorption therapy, including the CytoSorb treatment is a promising novel therapeutic approach, but only case-studies are available in the literature yet. Based on data from septic shock patient treatment the investigators hypothesize that CytoSorb is beneficial in early treatment of burns. The investigators aim to conduct a randomised-controlled study to assess the clinical effectiveness (based on score systems including MODS, SOFA, APACHE II, KDIGO, ABSI), 7 and 28 days survival, intensive care length of stay, length of mechanical ventilation, resuscitation fluid need and ino/vasopressor drug doses and the presence and severity of organ dysfunctions, particularly renal dysfunction. The investigatora plan to conduct basic research to elucidate the pathophysiological background of clinical effect, including the measurement of inflammatory and anti-inflammatory cytokines, presence and severity of oxidative stress (lipid peroxidation, protein oxidation, reduced/oxidised glutathion levels) and organ dysfunction markers (kidney injury molecule -1, neutrophil gelatinase-associated lipocalin, cystatin-C, uromodulin).

NCT ID: NCT04145609 Not yet recruiting - Acute Kidney Injury Clinical Trials

Intensified Acute Kidney Disease Care to Reduce Chronic Kidney Disease

ISACC
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Strategies to stop AKI-AKD-CKD continuum - Policy is one of the collaborative projects, Strategies to stop AKI-AKD-CKD continuum, Epidemiology, Immunology, Repair, Artificial intelligence, and Policy (EIRAP). It is aimed to study effective interventional strategies that lower the incidence of CKD among patients with AKD. The intensified AKD care to reduce CKD (ISACC trial) is a prospective, open-labeled, randomized controlled trial is designed to evaluate the efficacy of multidisciplinary team care (MDT) model and acute kidney disease (AKD) clinic visits

NCT ID: NCT04123145 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Study of the Prevalence of Iron Deficiency in Patients With Chronic Renal Failure But Non-Dialysis (CARENFER IRC-ND)

Start date: October 15, 2019
Phase: N/A
Study type: Interventional

Despite its known prevalence, a recent study conducted with Prof. Cacoub (unpublished) on the national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. In patients with Chronic Kidney Disease but Non-Dialysis, the determination of Ferritinemia and Transferrin Saturation Factoris performed in only 30% and 10% of cases whereas they should be performed routinely in inflammatory situations and in case of anemia (HAS 2011, KDIGO 2012). The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients with CKD-ND, applying the international recommendations and those of the French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor).

NCT ID: NCT04066855 Not yet recruiting - Clinical trials for Chronic Kidney Failure

Sclerostin and Vascular Calcification in CKD and Renal Transplant

Start date: December 2019
Phase:
Study type: Observational

the aim of the research is to determine the degree of vascular calcification in chronic kidney disease and post-transplant and whether there is a correlation with the level of serum sclerostin.

NCT ID: NCT04013620 Not yet recruiting - Clinical trials for Chronic Kidney Failure

CNI Transient Replacement by Belatacept From 3 to 12 Months Post Transplantation in Patients With Early Graft Dysfunction

TRANSIBELA
Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

Calcineurin inhibitors (CNI) remain the standard treatment in renal transplantation to prevent rejection. Currently the main limitation of kidney transplantation is the occurrence of chronic graft dysfunction due to the CNI nephrotoxicity. Thus, strategies to minimize or stop CNI have been developed as belatacept, a fusion protein (CTLA4-Ig) blocking the ligand of the main CD28 costimulatory molecule. In the original phase III trial, used de novo in combination with MMF (without CNI) belatacept allowed to obtain a better renal function as soon as 1 year and a better graft and patient survival after 7 years. Despite these excellent results, belatacept has not become the gold standard due to a higher incidence of early rejection. In addition, belatacept is not covered by the french social security policy, because benefits are considered insufficient with respect to the cost. Patients with poor early graft function are a preferred indication of belatacept. It is then used instead of CNI at 3 months post-transplant allowing to improve kidney function without over-risk of rejection. Currently after conversion, belatacept is maintained indefinitely due to the supposed CNI chronic nephrotoxicity. However this one is more and more questionable. Thus, the investigators assume that in patients with poor function at 3 months posttransplantation the belatacept's benefit could be obtained by a transient replacement of CNI by belatacept from 3 to 12 months post-transplantation. It is the feasibility of this strategy and its medico-economic impact that the investigators wish to study.

NCT ID: NCT04008953 Not yet recruiting - Clinical trials for Chronic Kidney Failure

Intravascular Volume Assessment Using Ultrasonography in Pediatrics Renal Transplant: A Prospective Cohort Study

Start date: July 2019
Phase:
Study type: Observational

This study is designed for volume assessment in pediatrics during major surgery using non-invasive tools as ultrasonography without the need of invasive techniques avoiding its complications and as a guide for fluid therapy needed for maintaining adequate hemodynamics

NCT ID: NCT03899298 Not yet recruiting - Stroke Clinical Trials

Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions

Start date: September 1, 2019
Phase: Phase 1
Study type: Interventional

To determine the safety and efficacy of Amniotic and Umbilical Cord Tissue for the treatment of the following condition categories: Orthopedic, Neurologic, Urologic, Autoimmune, Renal, Cardiac and Pulmonary Conditions. The hypotheses are that the treatments are not only extremely safe, but also statistically beneficial for all conditions. Outcomes will be determined by numerous valid outcome instruments that compile general quality of life information along with condition-specific information as well.

NCT ID: NCT03896750 Not yet recruiting - Tuberculosis Clinical Trials

Single-Dose Study to Evaluate the PKs of Pretomanid in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function

Start date: December 7, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase I, open-label, single dose, sequential group study to compare the safety and pharmacokinetics of pretomanid in the following groups of subjects: 1) subjects with severe renal impairment including those with End Stage Renal Disease (ESRD) not needing dialysis, and subjects with mild or moderate renal impairment, designated as Groups 2, 3, and 4, respectively; and 2) subjects with normal renal function matched to the above renal impairment groups, designated as Groups 1A, 1B, and 1C, respectively. The study will be conducted following a reduced Pharmacokinetic (PK) study design in Part A and Part B. Part A will enroll subjects from Group 1A (i.e., 6 healthy matched controls) and Group 2 (i.e., 6 subjects with severe renal impairment and ESRD, not on dialysis). A decision will be made after the PK of pretomanid and safety of subjects enrolled in Part A have been reviewed. If Part A demonstrated different pretomanid exposures at least a 50-100% increase in Area under the Curve (AUC) in Group 2 (severe renal impairments and ESRD, not on dialysis) relative to the exposures in Group 1A (matched subjects with normal renal function), then the reduced PK study will extend to the full PK study to enroll subjects into Part B (i.e., to investigate mild, and moderate renal impairment) and all enrollment will be initiated concurrently in Part B groups (1B, 1C, 3 and 4). If no difference in PK and safety is observed in Part A, then no further study (Part B) is recommended The approximate patient involvement will be 3 months. The primary objective is to evaluate the PK profiles of pretomanid in plasma and urine after a single oral dose of 200 mg in subjects with renal impairment compared to matched healthy controls.

NCT ID: NCT03845530 Not yet recruiting - Inflammation Clinical Trials

The Inflammatory Burden in Hemodialysis vs. Peritoneal Dialysis Patients: the Role of Alpha-defensin

Start date: March 2019
Phase: N/A
Study type: Interventional

The aim of this study is to determine the levels of alpha-defensin throughout the hemodialysis course compared to the levels at the end of a course of peritoneal dialysis, as a reflection of the inflammatory burden.

NCT ID: NCT03810989 Not yet recruiting - Clinical trials for Chronic Renal Failure

Dermodialysis as Adjuvant Therapy in Renal Failure

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Using sweat as the vehicle for removing molecules normally excreted in the urine(dermodialysis) was identified some decades ago.The study will include 66 ESRD patients and 20 CKD stage 5 patients not on dialysis who met inclusion and exclusion criteria. The ESRD patients will be divided into three groups and will be subjected to different modalities of stimulation of sweating like infra-red sauna , physical exercise and hot bath. The study will be conducted over a period of three months. During the first month, patients were dialyzed as usual (control phase).During the next two months ,the participants will be dialysed twice weekly in addition to dermodialysis. S Cr, BUN, serum K and serum phosphorus will be measured weekly immediately before the last dialysis session during the control and intervention phases. The mean of this investigations during each phase will be calculated . The investigators will compare the mean of this investigations during control phase with the mean during the intervention phase to evaluate the effectiveness of dermodialysis as adjuvant therapy for ESRD patients.The patients not on dialysis will subjected to infra-red sauna and hot bath.The investigators also will compare the means of S Cr, BUN, serum K and serum phosphorus during both control and intervention phases like the ESRD patients.