Clinical Research Directory

Kidney Transplant Improvement Through New Exercise Training to Increase Capacity

The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants. The main questions it aims to answer are: * Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list? * Do participants follow the exercise program and wear a physical activity tracker as asked? * Is the program safe and well tolerated? Researchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function: * Usual pre-transplant care with a physical activity tracker * Usual pre-transplant care plus an online exercise program Participants will: * Wear a wrist activity tracker to measure daily physical activity * Complete a one-week baseline period before being assigned to a study group * Be randomly assigned (like flipping a coin) to one of two groups * If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback * Answer questionnaires about their health, activity, and experience in the study This study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.

The Agenda-Setting for Kidney Disease Open Pilot Trial

The goal of this open pilot is to practice using an intervention and surveys before a larger pilot stepped wedge clinical trial. The intervention the researchers plan to use is Chronic Kidney Disease (CKD) Topics, and it is a structured clinical agenda-setting intervention (SAS), or a customized list of discussion topics. The people the researchers are practicing using the SAS with have advanced CKD (stages 4-5), and many of them live in rural areas. The researchers will practice administering CKD Topics, along with survey questions. By doing the open pilot, the researchers will learn if they need to modify the steps they plan to take in the larger trial. The main questions the researchers aim to answer are: * Do the steps for identifying eligible participants work? * Do the steps for administering CKD Topics work? * Do the steps to administer survey questions work?

Safety, Feasibility and Efficacy of Sulforaphane (Avmacol Extra Strength) in Chronic Kidney Disease

The Sulforaphane Production System® in Avmacol Extra Strength (ES) supplies broccoli seed extract (glucoraphanin) and Myrosimax® (Active Myrosinase Enzyme) which helps promote sulforaphane production in your body. The investigators hypothesize that daily intake of Avmacol ES can decrease kidney disease progression rate and decrease markers of oxidative stress and inflammation in Chronic Kidney Disease (CKD) patients. They will test this hypothesis in a randomized, double-blind, placebo controlled Phase 2 clinical trial. This proposed study has been funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), R01 DK128677.

The Agenda-Setting for Kidney Disease Trial

The goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. The SAS is called CKD Topics. The researchers will compare the SAS intervention to usual care (the way clinicians usually practice) to see how well it works for people with advanced CKD. This is a special type of clinical trial called a stepped wedge randomized clinical trial (RCT). In this type of trial, every participant will get to experience both usual care and CKD Topics, but for different amounts of time. The researchers will learn if doing a clinical trial of CKD Topics is possible (feasible) and get information about how well CKD Topics helps people with advanced CKD shape visit discussions (self-advocacy) in their appointments with their clinicians. The information the researchers collect in this trial will help design a future trial with more participants. The main questions the researchers aim to answer are: * Is it possible to conduct this type of study of a SAS intervention? i.e. feasibility * Does the SAS intervention help people with advanced CKD shape discussions (self-advocacy) with their clinicians? If so, how much? i.e. preliminary efficacy

Effect of Henagliflozin on Renal Outcomes in Non-dialysis Patients With Advanced Chronic Kidney Disease : A Multicenter Prospective, Randomized Controlled Trial（HERO -aCKD）

This is a multicenter, prospective, randomized, controlled study that will enroll approximately 429 subjects. The screening period will last 4-8 weeks. Subjects will undergo pre-screening based on eGFR and urinary albumin-to-creatinine ratio (UACR). Only non-dialysis subjects meeting the following criteria confirmed by local laboratories within 6 months prior to screening will be eligible for central laboratory screening: 10 mL/min/1.73m² ≤ eGFR \< 30 mL/min/1.73m² and 150 mg/g (16.95 mg/mmol) ≤ UACR \< 5000 mg/g (565 mg/mmol). Unless contraindicated due to intolerance, subjects with 20 mL/min/1.73m² ≤ eGFR \< 30 mL/min/1.73m² must receive stable, maximally tolerated labeled daily doses of ACEi or ARB for at least 4 weeks prior to randomization. For subjects with 10 mL/min/1.73m² ≤ eGFR \< 20 mL/min/1.73m², investigators will determine ACEi/ARB treatment based on patient condition per KDIGO guidelines. Other antihypertensive, lipid-lowering, and glucose-lowering therapies should be stabilized for approximately 4 weeks before randomization. Investigators are encouraged to maintain stability of medications known to affect serum creatinine levels during screening and approximately 2 weeks prior to any serum chemistry measurements throughout the study. Eligible subjects will be randomized in a 1:1:1 ratio to receive Henagliflozin (10 mg q.d., 5 mg q.d.) or conventional therapy. Thereafter, subjects will undergo laboratory assessments, concomitant medication review, adverse event collection, and clinical endpoint ascertainment at Week 4 (Day 30), Week 12 (Day 90), and Week 24 (Day 180), followed by every 12-week intervals. Throughout the study, all subjects will receive glycemic, blood pressure (target SBP \<140 mmHg and DBP \<90 mmHg), and lipid management according to current guidelines. All subjects will complete an end-of-study visit. Subjects discontinuing study drug prematurely should continue all subsequent study visits.

Clinical Effectiveness of MyNutriKidney®

This study is a 6-month, pragmatic, multi-center, sequentially recruited, stratified, open-label randomized controlled trial (RCT) conducted in Malaysia. It aims to determine the clinical effectiveness of a culturally adapted, gamified mobile health app (MyNutriKidney®) supplementing standard care, compared to standard care alone, for improving dietary self-management among 200 adults with Chronic Kidney Disease (CKD) stages 3-5. Participants will be randomly assigned (1:1, stratified by age and education) into either (i) the intervention group (MyNutriKidney® app + standard care) or (ii) the control group (standard care, including routine dietary counseling and printed materials). The co-primary outcomes are changes in Dietary Adherence (measured by CKD Diet Score) and Nutrition Literacy (measured by NLS score) from baseline to 6 months.

A Communication-Priming Intervention to Improve Shared Decision-Making Between Older Adults With Advanced CKD and Clinicians

To achieve the goal of reaching consensus about the preferred treatment option that best aligns with the goals and values of patients, the investigators developed a 'CKD Jumpstart- Tips" priming tool tailored for older adults with advanced CKD that is based on communication principles from VitalTalk and Elwyn's goal-based SDM model. The investigators hypothesize that compared with patients in the usual care group, patients in the 'CKD Jumpstart- Tips' intervention group will have: 1. increased level of shared decision-making (observer-based and patient-reported), 2. improved quality of communication, 3. increased patient involvement in decision-making, 4. lower decisional conflict, 5. lower decision regret, 6. decreased time to decision, 7. improved adherence to treatment choice, and 8. improved health-related quality-of-life.

Improving Medication Safety for Kidney Disease With a Digital Drug Dosing Tool in Nova Scotia Community Pharmacy Practice.

Chronic kidney disease (CKD) is a common condition. It occurs in approximately 7 out of 100 Canadians and is highest in rural settings. The kidneys are responsible for the removal of many drugs from the body. These drugs may require adjustment to avoid buildup. Individuals with CKD also tend to have multiple chronic conditions, are older, and are on many medications. Considering these factors, the risk for unwanted drug effects or harm are high. A recent medication review of a group of Nova Scotians with CKD referred from primary care to a specialist kidney clinic revealed that nearly 20% of high-risk medications should have been dose-adjusted or avoided. In Nova Scotia, community pharmacists' scope of practice now enables them to modify a prescription or prescribe a medication for a chronic condition except CKD. They are in an ideal position to protect or preserve kidney function through appropriate prescribing. Interviews of Nova Scotia community pharmacists in 2022 identified barriers and facilitators for kidney function assessment, medication dose adjustment and prescribing. Key findings indicated the need to develop a tool which would include agreed upon drug dosing based on kidney function, monitoring, medication specific benefits and harms, appropriate alternatives considering drug coverage and ideal medication prescribing to protect and preserve the kidneys. This study objective is to develop, validate, implement, and evaluate an electronic drug dosing and decision support kidney tool (eDoseCKD) in community pharmacy to improve medication safety and optimize kidney health. This project will consist of three phases. Phase one encompassed developing the tool based on evidence, clinician expertise and information learned from a previous study of pharmacists' interviews. Phase two will entailed tool validation or consensus by community pharmacists. In the present study, phase three, the implementation and evaluation of the tool in community pharmacies in Nova Scotia will be undertaken. We aim to answer, will this tool improve medication safety and prescribing in Nova Scotians with CKD? Participating patients will be surveyed to determine satisfaction with quality of care. Participating pharmacists will be interviewed after 6 months to assess barriers to and faciliators for using the computerized decision support alogirthms in community pharmacy practice.

Fluorescein Angiography in Patients With Diabetes and Chronic Kidney Disease

Our study hypothesizes that fluorescein exposure in diabetic patients with advanced chronic kidney disease results in deterioration of kidney function. It will therefore aim to evaluate the incidence of acute kidney injury induced by fluorescein in diabetic patients with CKD. The objective is to determine the incidence, severity and risk factors associated with this deterioration to improve the care of this specific population.