Clinical Research Directory

Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study

Chronic kidney disease affects a significant portion of the UK population, with approximately 3.5 million adults diagnosed. At its most severe stage, end-stage kidney disease, individuals require frequent dialysis treatment. One form of dialysis, known as peritoneal dialysis, involves introducing and removing fluid from the abdominal cavity to help filter out toxins from the body. The kidneys are involved in various hormonal processes, including those responsible for producing red blood cells, making anaemia a common consequence of kidney failure. When designing a clinical trial to evaluate the effectiveness of any treatment, it is essential to determine the number of suitable and willing participants, as well as those who can complete all required tests and measurements. Identifying the most appropriate measurement to assess the impact of intravenous iron (iron injected directly into veins) is crucial to ensure that any observed changes are meaningful to people with CKD and their carers. To address these considerations, the investigators will conduct a pilot feasibility trial. In this trial, individuals with kidney disease undergoing peritoneal dialysis will be randomly assigned to receive either high-dose or low-dose intravenous iron, or oral iron therapy. Over twelve months, the investigators will monitor their anaemia response, symptoms of kidney disease, quality of life, physical performance (such as the ability to walk for six minutes), and cognitive function. Additionally, the investigators will assess the impact of each intervention on the frequency of blood transfusions, whether those on oral iron require intravenous iron, and any changes in the dosage of erythropoietin-stimulating agents (drugs that increase blood production).

Continuous Glucose Monitoring in Dialysis Patients With Diabetes

The primary objective of this multicenter, randomized controlled trial is to assess whether the intermittent or continuous use of continous glucose monitoring can enhance glycaemic control among dialysis patients with type 1 or type 2 diabetes, in comparison to the standard monitoring involving finger-prick glucose and HbA1c. Participants will be monitored for 9 months and randomly assigned to one of three groups: * Group 1, the control group, will undergo standard monitoring (using HbA1c and BGM) along with double-blinded CGM sessions at month 0, 3, 6, and 9. * Group 2 will have intermittent access to open CGM during the same time intervals. * Group 3 will have continuous access to open CGM throughout the entire duration of the study. During the study period, participants will have three consultations with an endocrinologist for adjustments in their glucose-lowering treatment. The goal is to compare markers of glycaemic control between the three groups. Secondary objectives include evaluating the impact on hypoglycaemia, quality of life, hospitals admissions and cardiovascular events.

Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)

Doctors need to insert catheter for patients who are going to have peritoneal dialysis. These peritoneal catheters can be obstructed or blocked afterward. The chance of not having smooth flow can be up to 12 and 31%. So far, constipation is one of the proposed reasons. Therefore, the study is aimed to investigate whether the preventive use of laxative before the surgery can help better improve the function of the catheter and hence better flow.

Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use in Veterans

This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.

Blood Pressure Control With Thiazide Diuretics in Peritoneal Dialysis Patients

To evaluate the blood pressure lowering effects of thiazide diuretics in patients on peritoneal dialysis

Multi-omics Study of Peritoneal Dialysis Effluent to Explore Biomarkers of Peritoneal Fibrosis

Biomarkers of peritoneal fibrosis in patients with peritoneal dialysis were investigated by transcriptomics of exfoliated cells and metabolomics of exfoliated cells in peritoneal dialysis

Interdialytic Peritoneal UltraFiltration in HemoDialysis Patients

Sodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. Tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. Tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). Patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.

Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis

Moderate to severe pruritus significantly impairs the quality of life in peritoneal dialysis patients, and effective treatment options remain limited. κ-opioid receptor agonists may alleviate itching by modulating neural signaling pathways. This study is a multicenter, prospective, single-arm clinical trial, planning to enroll 93 patients. It aims to test the hypothesis that nalfurafine hydrochloride orally disintegrating tablets compared to baseline, with acceptable safety.

Comparison of Efficacy Between Nighttime and Daytime Peritoneal Dialysis

Background: Compared with continuous ambulatory peritoneal dialysis (CAPD), nocturnal continuous cyclic peritoneal dialysis (NCPD) uses a machine to exchange fluid to perform dialysis at night, allowing patients to work or study normally during daytime. Since the dialysis fluid retention time of NCPD patients is shorter than that of CAPD, this RCT was designed to investigate whether there is a difference in the efficacy between the two modalities on peritoneal dialysis. Design: Randomized, open-label, cross-over, multi-center clinical trial. Objective: Primary Objective: To compare the adequacy of peritoneal dialysis between NCPD and CAPD in non-diabetic patients. Secondary Objective: To compare the effects of NCPD and CAPD on the quality of life, including sleep quality, nocturnal blood pressure, and ultra-filtration volume in non-diabetic patients. Hypothesis: In non-diabetic patients, NCDP is non-inferior to CAPD in peritoneal dialysis adequacy. Methods: A total of 124 non-diabetic peritoneal dialysis patients will be enrolled and randomly assgined into two groups in a 1:1 ratio. Patients in group A will receive NCPD treatment from 1 to 12 weeks and then switch to CAPD treatment from 13 to 24 weeks, while patients in group B will receive CAPD treatment from 1 to 12 weeks and then switch to NCPD treatment from 13 to 24 weeks. All patients are required to sign an informed consent before enrollment. The enrolled patients are planned to be followed every 4 weeks, and unplanned visits will be arranged if necessary. The peritoneal dialysis adequacy (weekly total Kt/V) of the patients will be assessed at baseline and at the corresponding visit points. The average daily ultra-filtration volume during the two modalities of treatment will be compared. Sleep quality parameters will be collected using a contact-free continuous vital signs monitoring equipment at baseline, Week 12 and Week 24. The health-related quality of life and social function will be analyzed using the Kidney Disease Quality of Life 36-item short form survey (KDQOL-36) and Social Disability Screening Schedule (SDSS) questionnaire. Twenty-four-hour Ambulatory Blood Pressure (ABP) will be monitored at baseline, Week 12, and Week 24.

Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients

The study is a single center, open, prospective, self controlled clinical study. The patients with diabetes who are to be enrolled in peritoneal dialysis are to observe the changes of glycosylated hemoglobin relative to the baseline 90 days after using amino acid (15) peritoneal dialysis solution.

Dialysis Efficiency and Transporter Evaluation Computational Tool in Peritoneal Dialysis

The goal of this prospective diagnostic test (correlation) study is to develop and investigate the performance of artificial intelligence in predicting peritoneum transporter status and dialysis efficiency in adult patients undergoing peritoneal dialysis (PD). The main questions it aims to answer are: Can artificial intelligence predict peritoneal transporter status based on simple clinical and biochemical measurements? Can artificial intelligence predict dialysis adequacy (Kt/V) using these features? Researchers will compare the performance of the AI model with the gold standard Peritoneal Equilibration Test (PET) and Kt/V to evaluate its accuracy and reliability. Participants will: Provide peritoneal dialysate and spot urine samples for biochemical analysis. Undergo routine dialysis adequacy and peritoneal equilibration testing (PET). Have clinical and laboratory data collected for AI model training and validation. The study will recruit approximately 350 peritoneal dialysis patients, with 280 participants in the training/validation arm and 70 participants in the test arm. The study duration is 12 months following enrollment.

The Mobile-based Training System in Peritoneal Dialysis Patients

The mobile-based training system can effectively improve the knowledge and technical correctness of peritoneal dialysis patients.

The Factors Affecting IPP in Peritoneal Dialysis Patients with Polycystic Kidney Disease

Background: Polycystic kidney disease (PKD) is the most common hereditary kidney disease. Peritoneal dialysis (PD) in such patients is restricted because the significantly enlarged kidneys and liver may lead to the increase of intraperitoneal pressure (IPP). Increased IPP points to higher risk of abdominal wall complications and limited infusion volume that cause insufficient dialysis adequacy. Therefore, monitoring IPP is especially important in patients with polycystic kidney disease. However, the standard measurement of IPP is limited due to its cumbersome procedures, the application value of equation for estimating IPP among general peritoneal dialysis patients is not clear in the PKD population and the variables influence the IPP is yet to be explored.. Objective: The main purpose of our study was to validate the existing IPP equations in the PKD patients. Further, more relevant variables were included to optimize the IPP equation. Monitoring IPP can guide the formulation of peritoneal dialysis prescription for ADPKD patients, reduce the occurrence of abdominal wall complications, and the clinical utility and efficiency of PD was expanded. Methods: A multi-center cross-sectional study. The IPPs were measured using the Durand method, with whole-body and abdominal anthropometry indices, the volume of abdominal cavity, the total kidney volume and liver volume were collected. New equation for estimate IPP in PKD patients were generated by stepwise linear regression modeling. The eIPP were calculated using two developed equations previously. Then The bias, accuracy and precision of eIPP derived from new equation were compared with actual IPP by Durand method respectively.

The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients

This study aims to explore how daily physical activity (PA) levels affect the heart health and cognitive function of patients on peritoneal dialysis (PD). Using a fitness tracker, the investigators will measure how much patients move during the day and see if lower activity levels are linked to a higher risk of heart disease or memory issues. The study has two parts: Part A: The investigators will evaluate 266 patients to understand their current PA levels and how these relate to heart health and cognitive function. Part B: The investigators will follow the same patients over a year, measuring their activity at the beginning and after 12 months. The investigators will divide them into two groups-those who increase their PA and those whose PA decreases-and follow their heart health and memory function over two years. The goal is to understand whether higher PA levels can reduce the risk of heart problems and memory issues in PD patients.

Pharmacokinetics of Single- and Double-dose Icodextrin

The study aims to provide the pharmacokinetics profiles of single- and double-dose icodextrin in patients on peritoneal dialysis (PD). It may expand the available knowledge of the clinical pharmacology of icodextrin following its intraperitoneal administration and fills the gaps in our understanding of the fate of icodextrin and the metabolic consequences of icodextrin and its metabolites.

Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis

We hypothesize incremental peritoneal dialysis (incremental PD) protocol with icodextrin solution will help patients to achieve adequate ultrafiltration and adequate dialysis with less glucose exposure by manipulating a low frequency of exchanges, therefore prolong the time from incremental protocol to full dose protocol (Full dose dialysis is defined as a dialysis dose of more than 8 L (4 exchanges of 2 L) per day). The goal of this clinical trial is to investigate the effect of icodextrin postponing the shift of low dose to full dose dialysis in the first year of incremental peritoneal dialysis. The main questions are: * The effect of icodextrin on the shift of low dose to full dose dialysis in the first year in patients on incremental peritoneal dialysis. * The effect of icodextrin on clinical outcomes in patients on incremental peritoneal dialysis, such as the first episode of peritonitis, the incidence of anuria, the first incidence of hospitalization, technical failure, all cause mortality, cardiovascular disease free survival and the quality of life. Participants will be 1:1 randomized to the ICO (icodextrin) arm and CON (control) arm. Both arms patients will be followed every 2 months for fluid status by bioimpedance analysis. An extracellular water /total body water (ECW/TBW) ≥ 0.40 or edema is defined as overhydration (OH). The OH patients in the ICO arm will be prescribed icodextrin (Extraneal) for long night dwell to improve fluid overload till their re-measurement of ECW/TBW \< 0.40 or edema disappeared. The OH patients in the CON arm will be prescribed hypertonic Dextrose solution for long night dwell to improve fluid overload till their ECW/TBW \< 0.40 or edema disappeared. Researchers will compare the time of transferring from low dose PD to full dose and the clinical outcomes in the first year between the patients in ICO and CON groups to see the effect of icodextrin on the shift of low dose to full dose dialysis and clinical outcomes in the first year in patients on incremental peritoneal dialysis. Successful completion of the study will advance our strategy of incremental PD and help to prolong the shift from incremental to full dose dialysis, and offer new opportunities for the development of an effective and economical therapy for PD patients with residual kidney function (RKF)

Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients

This study will investigate the impact of exercise on gastrointestinal function in peritoneal dialysis patients.