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Kidney Diseases clinical trials

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NCT ID: NCT06086470 Recruiting - Clinical trials for Kidney Disease, End-Stage

Evaluating the Use of the Qidni/D Hemodialysis System by Subjects With End-Stage Renal Disease

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The main goal of this clinical study is to evaluate the safety of the Qidni/D Hemodialysis System in patients with end-stage renal disease. The main question it aims to answer is: Is the Qidni/D safe for performing hemodialysis? Participants will be subjected to one treatment of hemodialysis for up to 4 hours with the use of the Qidni/D.

NCT ID: NCT06069518 Not yet recruiting - Clinical trials for Diabetes Mellitus Type 2

Continuous Glucose Monitoring in Patients With Diabetes on Peritoneal Dialysis

Start date: November 1, 2023
Phase:
Study type: Observational

Background: The patient presenting Chronic Kidney Disease, with etiology of diabetes mellitus (DM), has a metabolic alteration characterized by an elevation of glycemia and accompanied by cardiovascular complications, this increases the morbidity and mortality associated with the disease. Therefore, it is necessary to maintain adequate metabolic control to reduce the incidence of these complications. This task is extraordinarily difficult without the use of Icodextrin due to the optimal adjustment of insulin, due to the additional supply of glucose contained in the Dialysis Bosas and which is absorbed through the peritoneum. Under this premise, it is of utmost importance the surveillance of the patient through constant glycemic monitoring to provide an overview of the metabolic status of our patients, this will allow clinically relevant data to improve care, minimize expenses in the health system and implement measures for decision making in the adjustment of dialysis treatment. Objective: To use continuous glucose monitoring to detect whether the type, dose, route of administration and timing of insulin application are associated with the patterns provided by continuous glucose monitoring (magnitude and duration of periods of hyper and/or hypoglycemia) in 24-hour periods of tissue glucose. Material and methods: This is a cross-sectional, non-interventional study in adult patients with Type 2 Diabetes Mellitus on Peritoneal Dialysis in its Automated modality who present high and high average peritoneal transport type. As inclusion criteria, participants over 40 years of age, of any sex, diagnosed with Diabetic Nephropathy, and who are insulin-dependent for metabolic control, with at least three months of PD treatment. The project will consist of evaluating the patient's glycemic control continuously, with an automatic scan and data recording every six hours during the infusion time of Automated Peritoneal Dialysis. For this, 110 patients are required according to the sample size. The Guardian TM 3 Sensor will be placed using the One PressTM Grafter subcutaneously in the upper posterior region of the patient's non-dominant arm, it is a minimally invasive procedure that does not require surgical protocols. This sensor will be connected to the Guardian Connect Transmitter for continuous communication with the Guardian™ Connect (App). The sensor has an approximate life of 7 days (time that lasts the enzymatic reaction and that allows an adequate measurement) the data will be transmitted every five minutes 24 hours a day, for 7 consecutive days. The patient will be scheduled at the end of these days to place a second sensor and complete the 14 days of follow-up. On day seven, the patient will be scheduled for sensor removal, and a new one will be placed to complete 14 days of follow-up. On day 14, the total 24-hour PD drainage volume will be recovered for a glucose, urea and creatinine measurement and peritoneal glucose absorption, D/P creatinine and Kt/V will be calculated. The dietary information will be obtained for the calculation of calorie intake and meal time; it is together with the subcutaneous application of insulin will be recorded within the same GuardianTM Connect (App). Statistical analysis: The databases will be audited in monthly periods by random sampling in blocks of 5% of their content. Semi-annual reports will be integrated with the monitoring of the records achieved and the outcomes to date of the reports. The reports will contain the basic descriptive information (central tendency and dispersion) according to the characteristics of the variables. Patients will be classified according to the time of glucose measurements within the pre-established ranges (70-180 mg / dL), the goal is that 70% of the time they are in that range and will be called "Adequate" and those who do not reach the goal will be called "Not Adequate". The results will be reported with measures of central tendency and dispersion appropriate to the characteristics of the variables. For the detection of difference between the appropriate and inappropriate group, the Chi square statistic or the Student's T or Mann-Whitney U will be used according to the type of variables. For the association analysis that allows detecting the variables of greatest influence on glycemic control in the recommended ranges with continuous glucose monitoring, logistic regression analysis will be used. In a first stage, analysis will be done by independent variable and in a second stage, a multivariate analysis will be made, where the type of insulin, the route of administration, the dose and the schedules will be considered. At this stage, confounding variables will also be included, such as; obesity, adherence to treatment and diet and physical activity prescribed by the treating physician.

NCT ID: NCT06067867 Recruiting - Kidney Diseases Clinical Trials

Kidney and Pregnancy Registry

Start date: September 12, 2023
Phase:
Study type: Observational [Patient Registry]

Maternal physiological adaptation to pregnancy plays an important role in the smooth progress of the pregnancy and the healthy growth of the fetus. This physiological adaptation takes place at the level of several organs, including the kidney. Physiological changes during a normal pregnancy take place at the anatomical, glomerular and tubular level. In the event of pre-existing kidney damage (glomerular and tubular diseases, stone disease, high blood pressure (hypertension) etc...) these adaptations will not be optimal. This will have implications for: - the course of the pregnancy with the occurrence of feto-maternal complications: miscarriages, pre-eclampsia, intrauterine growth retardation (IUGR), low birth weight, prematurity. The risk of feto-maternal complications increases with the degree of renal failure or with certain pathologies such as lupus. - progression of kidney disease Some maternal complications have long-term implications: preeclampsia is associated with a high risk of subsequent cardiovascular and renal complications. Pregnancies in these patients are high-risk pregnancies and require specialized management by an experienced group of gynecologists and nephrologists. The creation of a retrospective and prospective register by collecting demographic, clinical, biological, radiological and genetic data concerning patients at each consultation within the CHU Brugmann Hospital will allow: - to establish the epidemiological and clinico-biological characteristics of the patients followed at the Kidney and Pregnancy Clinic at the CHU Brugmann Hospital - to analyze the risk factors for feto-maternal complications - to analyze the risk factors for the occurrence of subsequent cardio-renal pathologies in patients who have had preeclampsia or an event during their pregnancy - to identify patients who will need specialized genetic testing

NCT ID: NCT06067009 Recruiting - Kidney Diseases Clinical Trials

Feasibility Trial of a Stakeholder-enhanced Lay-navigator-delivered Intervention (ImPart-Multi)

ImPart-Multi
Start date: March 20, 2024
Phase: N/A
Study type: Interventional

We seek to explore the feasibility and acceptability of participation in a decision-support training program led by lay navigators. ImPart-Multi, an education-telehealth-based, is designed to empower Black chronic kidney disease patients (CKD) patients and their care partner to seek the resources and support needed to be activated allies when making health-related decisions. Participants, based on random assignment, will participate in survey completion at study start and at 12 and 24 weeks of enrollment, and will complete 1, 3, or 4 education sessions via telehealth or audio connection. Participants will also complete an interview to share their thoughts on the program and other factors of interest.

NCT ID: NCT06018831 Recruiting - Kidney Diseases Clinical Trials

Urine and Ultrasound Screening for Kidney Disease in Children

Start date: April 12, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to early detect kidney disease in the natural population cohort of children by urine and ultrasound screening, to assist in the precise prevention and treatment of children's kidney disease, and to establish a risk prediction system for children's kidney disease. About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Through the project, child who is found with abnormal urine or ultrasound result will be referred to Children's Hospital of Fudan University to get further examination and treatment.

NCT ID: NCT05991245 Recruiting - Acute Kidney Injury Clinical Trials

French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"

MATRIX
Start date: January 1, 2023
Phase:
Study type: Observational

Thrombotic microangiopathies (TMAs) are a diverse, rare but serious group of diseases. Progress has been made regarding the epidemiology of TMA (Bayer CJASN 2019). It has been shown that secondary TMAs account for 95% of cases, whereas primary TMAs (atypical hemolytic syndromes (HUS) and thrombotic thrombocytopenic purpura (TTP)) account for only about 5%. However, in many cases, the pathophysiology, optimal management and prognosis of TMA remains unclear and it has been shown that patients with TMA may have renal-limited TMA or renal and hematological TMA (ie. With (mechanical anemia, thrombocytopenia, elevated LDH, decreased haptoglobin, schistocytes). In most studies, kidney biopsies are not performed and the diagnostic workup is uncomplete. As this is a rare disease, only a multicenter approach (>20 centers) over a long period of time (>10 years), with adequate diagnostic workup including kidney biopsies can help us to answer these questions (investigators in the present are usually members of the CNR-MAT (a network of the TMA centers in France).

NCT ID: NCT05970094 Completed - Kidney Diseases Clinical Trials

Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5

REMA-CKD
Start date: March 6, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control. The hypothesize is, that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements.

NCT ID: NCT05943977 Completed - Kidney Diseases Clinical Trials

A Bioequivalence and Efficacy Study of MB-102 (Relmapirazin) in Chinese Participants

Start date: March 2, 2023
Phase: Phase 3
Study type: Interventional

Part I (bioequivalence) will evaluate the bioequivalence of the Oversea Manufactured Sample (used in the MediBeacon Phase 3 Study 100-103; NCT05425719) and Domestic Manufactured Sample in Single Intravenous Dose of MB-102 (Relmapirazin) in healthy Chinese adults. Part II (efficacy) will evaluate the performance of the MediBeacon Transdermal GFR Measurement System and Domestic Manufactured Sample of MB-102 (Relmapirazin) for Evaluation of Kidney Function in Chinese participants.

NCT ID: NCT05935748 Recruiting - Neoplasms Clinical Trials

Ph2 Study NKT2152 With Palbociclib & Sasanlimab in Subjects With Advanced Clear Cell Renal Cell Carcinoma (ccRcc)

Start date: July 28, 2023
Phase: Phase 2
Study type: Interventional

The goal of the Lead-in phase of the study is to evaluate the safety, efficacy, pharmacokinetics (PK) and determine recommended dose for expansion (RDE) of NKT2152 in combination with palbociclib (Doublet) and with palbociclib and sasanlimab (Triplet) in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior therapy. The goal of the Expansion phase of the study is to evaluate the safety, efficacy, PK at the selected RDE and identify the RP2D for NKT2152 in combination with palbociclib (Doublet) and with palbociclib and sasanlimab (Triplet) in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior therapy.

NCT ID: NCT05887245 Recruiting - Clinical trials for Renal Cell Carcinoma

Clinical Significance of Adherent Perinephric Fat in Patients Undergoing Partial Nephrectomy

Start date: April 17, 2023
Phase:
Study type: Observational

The aim of this study is to gain a better understanding of the phenomenon of adherent perinephric fat (APF), which occurs in some patients undergoing partial nephrectomy (PN). This phenomenon, so-called "toxic fat", is a commonly recognized problem among urologists, but its significance has not yet been fully understood. The study aims to identify new clinical risk factors for APF occurrence and evaluate its impact on functional, perioperative, and oncological treatment outcomes. The study will be conducted on patients who are qualified for PN surgery. Prior to the surgical procedure, venous blood will be collected, which will be used for various measurements, such as blood morphology, kidney parameters, inflammation markers, liver function tests, glucose, and lipid profile. In addition, medical data will be collected concerning the patient's overall health, observed changes in the kidney, perioperative course, hospitalization, and histopathological characteristics of the tumor. After treatment, patients will be followed up for up to 60 months. The knowledge gained from this study can significantly assist in making decisions about surgical treatment and thus contribute to improving the treatment outcomes of patients with kidney tumors.