Clinical Research Directory

Benefits of a Renal Rehabilitation Program Adapted to Uremic Patients on Daily Hemodialysis at Low Dialysate Flow Rate.

The concept of renal rehabilitation has become increasingly important with the increasing age of patients with severe or even terminal chronic kidney disease (CKD). It combines physical exercise and nutritional monitoring programs for patients with terminal CKD who are most often treated with conventional hemodialysis (HD) at a rate of 3 sessions of 4 hours per week. Sarcopenia is a very common phenomenon in patients with CKD. The prevalence found in recent meta-analyses varies between 25.6 and 28.5% in patients treated with dialysis. It is even higher in patients treated with HD than in patients treated with peritoneal dialysis (PD). Younger and more active patients will more often choose PD. The conventional HD modality preserves residual renal function less well, which is important for better elimination of uremic toxins bound to plasma proteins. Conventional HD requires a higher immobilization time and causes more post-dialysis symptoms, leaving less time for the patient to be physically active. The phenomenon of sarcopenia is not insignificant. It is associated in dialysis patients with a higher mortality rate (risk x 1.8) and a higher incidence of cardiovascular events (risk x 3.8). The association with higher mortality is well demonstrated for the 2 main components of sarcopenia, namely reduced muscle mass and reduced muscle strength. Sarcopenia also increases the risk of falls and fractures, it decreases the physical performance of patients and their ability to perform activities of daily living. The quality of life of patients is reduced and the probability of social placement is high. The phenomena of sarcopenia and physical deconditioning are even more problematic in patients in HD after an acute medical problem. The need for rehabilitation is even higher. "Classical" HD treatment can be a burden for these patients, leaving no room for integrating a complete rehabilitation program. Daily low dialysate flow rate hemodialysis (LDF) is a type of hemodialysis in which patients benefit from more frequent but shorter and hemodynamically better tolerated HD sessions. This new technique potentially presents certain advantages over conventional HD, particularly at the cardiovascular level: better blood pressure control and better reduction of left ventricular hypertrophy. LDF also allows better control of hyperphosphatemia with a reduced need for phosphorus binders. Thanks to more frequent dialysis (5 to 6 sessions per week), inter-dialytic weight gain is often less significant, allowing less aggressive ultrafiltration, with better hemodynamic tolerance, and better post-dialysis recovery. In this perspective, this study aims to examine the interest of integrating HDQ dialysis into a renal rehabilitation program in patients with terminal CKD whose dialysis must continue after an acute event requiring hospitalization. The investigators want to study whether this technique allows the implementation of a more effective rehabilitation program, while maintaining the same dialysis efficiency as with the conventional HD technique. To the investigator's knowledge, no study concerning patients under HDQ has been conducted during their renal rehabilitation phase. The objectives of the current study are: * To study the interest of integrating HDQ dialysis into a renal rehabilitation program in patients with terminal CKD. * To study the efficacy and tolerance of HDQ dialysis and the rehabilitation program in these patients.

Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients

The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.

Creation of Arteriovenous Fistulas for Hemodialysis Using the End-to-side Anastomotic Technique vs. Piggyback.

This study is designed to compare two surgical techniques used to create arteriovenous fistulas (AVFs), which are necessary for hemodialysis in patients with advanced chronic kidney disease (CKD). AVFs are preferred over other forms of vascular access because they last longer and have fewer complications. However, many AVFs fail to mature properly, making them unusable for dialysis. The two techniques being studied are the traditional End-to-Side (ETS) method and a newer technique called Piggyback Straight Line Onlay Technique (pSLOT). Early studies suggest that pSLOT may reduce complications like narrowing (stenosis), clotting (thrombosis), and failure of the AVF, but more robust data from randomized clinical trials is needed. Patients aged 18 or older with stage 4 or 5 CKD, who are eligible for a new AVF and meet health criteria, may participate. During the operation, participants are randomly assigned to receive either the ETS or pSLOT technique. The procedure is done under local or regional anesthesia. Follow-up appointments are scheduled at 1 and 12 months to assess fistula maturation, blood flow, and whether it can be successfully used for dialysis. Remote follow-ups are allowed if needed. Participation is voluntary, requires informed consent, and all data is kept strictly confidential. The study follows national and international ethical standards and has been approved by an ethics committee.

DIALysis With EXpanded Solute Removal

The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is: 1\) Does expanded hemodialysis reduce the risk of death from any cause? Researchers will compare expanded hemodialysis to conventional hemodialysis (the treatment currently used for the majority of patients receiving hemodialysis) to see if expanded hemodialysis works to improve patient outcomes. Participants will continue to receive their regularly scheduled hemodialysis treatments using either a super high-flux/expanded dialysis filter or a high-flux/conventional dialysis filter. All other aspects of treatments remain the same. No additional tests or visits are required. Data will be obtained using administrative healthcare databases and medical record review (at a subset of participating locations).

Early Feasibility Study of the Velocity™ Percutaneous Arterio-Venous Fistula System for Creating Hemodialysis Vascular Access

The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.

Aerobic Versus Resistive Intradialytic Training Effect on Atherogeinc Index in Hemodialysis Patients

the goal of the clinical trial is to study the effect of aerobic and resistive exercises on atherogenic index in hemodialysis patients the study will include three groups of both sex the first group will participate in aerobic exercise ,the second group will participate in resistive exercise and the third group will be control group

Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients

The goal of this clinical trial is to assess the efficacy of a 2-month live online mindfulness meditation program in reducing perceived fatigue (measured by the SONG-HD Fatigue Scale) in patients undergoing chronic hemodialysis. The sponsor expects that a live online mindfulness meditation course will have a significant public health impact by reducing perceived fatigue, which is strongly associated with cardiovascular events, mortality, and reduced quality of life. Participants will be enrolled according to eligibility criteria and randomized into one of the following groups: Experimental group: will receive an 8-week live online Mindfulness-Based Stress Reduction (MBSR) program. Control group: will receive standard care during their hemodialysis sessions and will be offered the same live online MBSR program between months 8 and 10. Patients will complete self-administered questionnaires at baseline, 2 months, 8 months, and 10 months to monitor changes in fatigue, anxiety, and quality of life.

Effect of Zinc Supplementation on Hyperhomocysteinemia Compared to Folic Acid in CKD Patient on Hemodialysis

Hyperhomocysteinemia is a well-recognized risk factor for accelerated cardiovascular events in hemodialysis patients. Hyperhomocysteinemia is common in individuals with chronic kidney disease (CKD). Zinc is a vital cofactor for homocysteine metabolism enzymes. Although numerous studies have demonstrated the efficacy of folic acid in hyperhomocysteinemia, zinc supplementation has the potential to reduce homocysteine levels in hemodialysis patients. Objective: To evaluate the effect of Zinc supplementation on hyperhomocysteinemia compared to that of folic acid in patients with chronic kidney disease on hemodialysis. Materials and Methods: This open-label randomized active-controlled trial will be conducted in the Department of Nephrology of Chittagong Medical College Hospital, Chattogram, Bangladesh, for one and a half years. A total of ninety CKD patients on maintenance hemodialysis will be included in the study. Patients will be randomly divided into two groups. The experimental group will be treated with zinc sulfate (50 mg elemental zinc/day) for six weeks in conjunction with conventional treatment for CKD. The Control group will receive folic acid (5mg/day) along with conventional medications for CKD. The primary outcome measure will be the change in the plasma homocysteine level after 6 weeks, while the other variables will include serum creatinine, eGFR, serum albumin and C-reactive protein (CRP) level. Adverse events and safety measures will also be recorded. The primary analysis will be an intention to treat analysis performed with SPSS-23. Data from previous studies indicate zinc supplementation can reduce homocysteine levels in CKD patients facilitating its metabolism. Additionally, the anti-inflammatory properties of zinc may facilitate homocysteine reduction. Moreover, zinc is crucial in various physiological processes, including immune function, protein synthesis, and wound healing. Further clinical trials are still needed to understand better the safety and efficacy of zinc supplementation in CKD patients.

Effect of a Structured Physical Exercise Program on Arteriovenous Fistula Maturation for Hemodialysis in Chronic Kidney Disease Patients

For patients living with Chronic Kidney Disease who are preparing to start hemodialysis, having a well-functioning arteriovenous fistula (AVF) is essential. Although the AVF is considered the best type of vascular access, its maturation process does not always go as expected-studies show that in 28% to 53% of cases, the fistula does not mature properly, making effective dialysis more difficult. There is growing interest in using physical exercise as a way to support AVF maturation. International guidelines even recommend arm exercises for this purpose. However, there is still no clear agreement on what type of exercise, how often, or how intense it should be. This study aims to evaluate whether a structured exercise program focused on the AVF arm can help improve the fistula's development and overall function.

Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study

Patients with end-stage kidney disease (ESKD) on hemodialysis face an unacceptably high rate of cardiovascular complications, including heart failure, arrhythmias, and sudden cardiac death. Many of these outcomes are driven by diastolic dysfunction and cardiac fibrosis-conditions that are not adequately addressed by current therapies. SGLT2 inhibitors, originally developed for the treatment of type 2 diabetes, have demonstrated cardiovascular and renal protective effects across multiple patient populations, independent of glycemic control. This Phase 2, randomized, controlled clinical trial will evaluate the safety and efficacy of SGLT2 inhibitors in patients undergoing maintenance hemodialysis. A total of 80 participants will be randomized to receive either an SGLT2 inhibitor or standard care for 12 months. The primary objective is to determine whether SGLT2 inhibitors improve cardiac function, reduce myocardial fibrosis, and decrease the incidence of intradialytic hypotension. Secondary endpoints include cardiovascular events, hospitalization, and all-cause mortality. The study will also assess changes in key biomarkers and perform advanced cardiac imaging to evaluate structural and functional outcomes. This trial represents a novel and timely investigation into a class of medications with promising pleiotropic effects, potentially offering new therapeutic options for a high-risk, underserved population.

Ultrasound Prediction of Successful Balloon Assisted AVF Maturation

An arteriovenous fistula (AVF) is created to allow for cleaning of the blood in patients with severe kidney disease. An artery and a vein are surgically connected, typically in the arm. This connection changes how the blood flows through the vessels, creating much higher flow in the arm vein than before the operation. Higher blood flow enables blood flow to be cleaned externally with a machine replacing the function of the kidneys. This process is known as dialysis. However, a period known as maturation is required before an AVF can be used in this way. During this time, the vessels grow in size and blood flow continues to increase. In some cases this does not happen and a procedure is required to help the AVF to mature. AVFs not likely to mature may undergo a procedure, known as balloon assisted maturation (BAM), in which a balloon on the end of a catheter is inserted into the AVF vein and inflated. This is typically needed if an AVF is not likely to develop in a way that can be used for dialysis. Blood cleaning, or haemodialysis, is vital in patients with end stage renal disease, or kidney failure. Blood flow measurement using ultrasound, and routine blood test results, may help us predict which AVFs will respond better to BAM. Ultrasound can be used in the clinic setting and can provide the consultants responsible for the patients ongoing management with information that can enable decisions to be made at an early opportunity, and allowing the participants to be involved in future management decisions. This study aims to identify features of the blood flow following the BAM procedure that might be used to predict if the AVF will successfully mature.

A Study to Evaluate Safety, Tolerability and Efficacy of AP306 At Fixed Doses in Patients with Hyperphosphatemia

The goal of this clinical trial is to learn if AP306 could work in the patients receiving maintenance hemodialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP306 lower blood phosphate levels when the participants take a fixed dose of AP306? * What medical problems do the participants have when taking AP306? The researchers will compare AP306 to a placebo (a look-alike substance that contains no drug) to see if AP306 works to treat hyperphosphatemia. The participants will: * Stop all using blood phosphate-lowering drugs, and * Take AP306 or a placebo three times a day for 12 weeks. If the participant has a blood phosphate level above a certain level, they will receive additional treatment to lower the blood phosphate level.