Nephropathy

Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups: one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.

Researchers are evaluating the pharmacokinetics, or how the body processes, of one or two doses of the drug MK-2828 in people with kidney disease. The study aims to determine if the way MK-2828 behaves in individuals with certain types of kidney impairment is similar to that in healthy people. This research is a Phase 1 clinical trial focusing on participants with severe renal impairment, end-stage renal disease (ESRD), and healthy controls. Participants with severe renal impairment will receive a single oral dose of MK-2828 on Day 1. Those with ESRD on hemodialysis will receive a single dose in each of two study periods, separated by at least 14 days. Healthy participants with normal kidney function will receive a single dose on Day 1. The trial is open-label, meaning all participants and researchers know which treatment is given. During the study, participants will have blood samples collected before dosing and at various times up to 192 hours afterward to measure drug levels and related pharmacokinetic parameters. Those on hemodialysis will have additional assessments related to dialysis clearance. Safety will be monitored through tracking adverse events up to approximately 14 days. The study will continue until July 2026, with participants involved in a single-dose administration and follow-up sampling and observation.

Researchers are evaluating the use of sodium zirconium cyclosilicate (SZC) to help optimize renin-angiotensin aldosterone system inhibitor (RAASi) therapies in elderly patients aged 70 and older who have heart failure and chronic kidney disease. Many patients with these conditions do not receive recommended RAASi doses because of elevated potassium levels, which can be dangerous. This study aims to see if adding SZC allows safer and more effective use of RAASi medications by managing potassium levels. This is a randomized, open-label clinical trial where eligible participants who have been hospitalized for heart failure worsening and have mild or at-risk hyperkalemia will be assigned to one of two groups. One group receives SZC along with standard RAASi treatment, while the other receives RAASi treatment alone without potassium binders. The treatment period lasts three months, during which RAASi doses are adjusted following European Society of Cardiology guidelines. Participants will be monitored from screening through three months of treatment to measure how many can increase their RAASi doses by at least 25%. Evaluations include clinical assessments, potassium level monitoring, and adherence to therapy. The study will also track secondary outcomes related to higher dose increases. Safety and treatment effects will be observed throughout the trial, which is expected to provide important insights for managing these conditions in elderly patients.

Researchers are establishing a prospective group of patients with plasma cell disorders (PCDs) to better understand these conditions and their treatments. This study focuses on various PCDs including multiple myeloma, amyloidosis, and other related disorders. It aims to explore how minimal residual disease (MRD) status relates to patient prognosis and investigate the role of the tumor microenvironment (TME) in the disease's development and progression. Patients with confirmed PCDs who are hospitalized and willing to participate will be followed over time. Biological samples such as peripheral blood, bone marrow aspirate, and urine will be collected before and after treatment to support future research. The study does not involve any intervention and participants will be regularly assessed at baseline, then at 1, 3, 6, and 12 months after treatment, followed by yearly visits. During the study, clinical and laboratory data along with biological samples will be gathered to analyze disease features and treatment responses. Follow-up visits will monitor patient progress and outcomes for up to ten years. The main outcome is to maintain a comprehensive cohort and understand the relationship between MRD and prognosis in PCD patients, while also supporting further studies on tumor clone evolution and disease mechanisms.

Researchers are evaluating the effects of intensive weight loss treatment on renal outcomes in patients with diabetic kidney disease (DKD), particularly focusing on those with rapidly progressing diabetic nephropathy. The study aims to establish a patient group receiving such treatments and to develop a prediction model for kidney health improvements following weight loss. Participants are divided into two groups: one receiving bariatric surgery, which includes laparoscopic sleeve gastrectomy or laparoscopic gastric bypass based on beta-cell function, and another group receiving non-surgical therapy comprising diet management, exercise, metformin, GLP-1 receptor agonists, and other weight loss medications. The study monitors outcomes at 1, 3, 6, and 12 months after intervention. During the study, participants will have regular assessments measuring total weight loss, kidney function markers such as serum creatinine and glomerular filtration rate, various blood glucose parameters, waist and hip circumference, urinary microalbumin, other urine tests, and medication status. These evaluations help track the impact of the treatments on kidney health and metabolic control over the course of one year.

This research aims to compare two timings of physical therapy for adults with end-stage renal disease (ESRD) who are undergoing hemodialysis. The study evaluates whether exercising during dialysis sessions or before dialysis leads to better improvements in physical function, quality of life, and laboratory measures such as hemoglobin and electrolyte levels. A total of 72 adult participants will take part in this randomized controlled trial to help determine the best approach to physical therapy in this population. Participants will be randomly assigned to one of two groups. One group will perform supervised physical therapy exercises during their dialysis sessions twice weekly for 12 weeks, while the other group will perform the same exercises before their dialysis sessions on the same schedule. Each session lasts about 30 minutes and includes warm-up, resistance training, and cool-down. Both groups will first receive standardized education about the benefits and safety of exercise before starting the intervention. Throughout the study, participants will undergo assessments including the Six-Minute Walk Test, Five Times Sit-to-Stand Test, and quality of life questionnaires at baseline, every four weeks during the 12-week intervention, and at a 6-month follow-up. Blood tests to measure hemoglobin and electrolyte levels will be done at baseline and at 4, 8, and 12 weeks. The study monitors these outcomes to evaluate the effects of exercise timing on health and well-being for individuals on hemodialysis.

Researchers are evaluating whether using an automated Carbon Dioxide (CO2) injection system during infrainguinal peripheral vascular interventions (PVI) can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury (CA-AKI). This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.

Researchers are evaluating the use of a high protein egg white pudding as a nutritional supplement for people with kidney failure who are on dialysis. The study aims to find out if giving this egg white pudding after dialysis is practical and whether it can improve blood protein levels, frailty, dietary intake, and other blood markers compared to a standard supplement called Ensure Plus. This trial is conducted by Seven Oaks Hospital Chronic Disease Innovation Centre. Participants will be randomly assigned to receive either the egg white protein pudding or Ensure Plus at the end of their dialysis treatments three times a week for 12 weeks. Both supplements are dietary and taken during the dialysis sessions. The study collects data during this 12-week intervention period to evaluate the effects of the two supplements. During the study, participants will be monitored for their ability to stay in the trial, adherence to the supplements, and health measures such as hand grip strength, walking speed, balance, and blood levels including serum albumin and electrolytes. These assessments occur at the end of the 12 weeks. The trial also tracks recruitment and follow-up rates to evaluate feasibility. Overall, participants are involved in regular supplement intake and health testing during dialysis over three months.

This research aims to evaluate the long-term safety of up to two injections of a gelatin-hydrogel formulation called Renal Autologous Cell Therapy (REACT), given 3 to 6 months apart into the same kidney. The study focuses on participants with chronic kidney disease (CKD) who have previously received REACT in earlier clinical trials. The goal is to monitor how these treatments affect kidney function over time. This observational extension study involves up to 80 participants who were treated with REACT in prior interventional studies (RMCL-002, REGEN-003, REGEN-004). Participants will be followed for up to five years through a series of alternating in-clinic and phone visits. No new treatments are given during this study; rather, it is designed to observe the long-term effects after prior exposure to REACT. During the study, participants will undergo regular assessments to monitor kidney function and safety outcomes. Researchers will measure kidney function decline, dialysis requirements, and kidney transplant events over a 60-month period from the end of the previous trial. The study includes various safety checks and long-term follow-up to understand how REACT affects participants over several years.

Researchers are evaluating the safety and effectiveness of starting budesonide enteric coated capsules early to treat primary IgA nephropathy, a kidney condition. This prospective, open-label study involves multiple centers and aims to observe changes in proteinuria levels and monitor for any treatment-related abnormal lab values or adverse events over about 12 months. Participants will receive targeted-release budesonide capsules as part of the study. The research includes collecting and testing Gd-IgA1 levels in enrolled subjects. The study is observational, focusing on early initiation of therapy for patients diagnosed within 3 months, with kidney function and protein levels meeting specific criteria. During the study, participants will be regularly assessed for kidney function, protein in urine, microscopic hematuria, and metabolic changes through laboratory tests and urine analysis. Researchers will also track serious kidney outcomes and side effects related to treatment. The total participation period covers about 12 months, including follow-up to evaluate the long-term effects of the therapy.