Clinical Research Directory

Exploring Life Experience and Lifestyle Intervention Program Among Patients With CKD

to compare the effectiveness of tailored TTM-based interventions (intervention group) compared to usual care (control group) on biomarkers of kidney function, physical indicators, adoption of health-promoting lifestyle behaviors, kidney disease knowledge, perceived self-efficacy, perceived benefits and barriers to physical activity changes, and quality of life among patients with early-stage CKD over a 30 month period.

Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease

This study is a cluster-randomized clinical trial to evaluate whether a tailored, user-centered, clinical decision support (CDS) tool can positively influence prescriber behavior and increase prescription of guideline-directed medical therapy (GDMT) among patients with Chronic Kidney Disease (CKD) across a single healthcare center.

Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial

The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo.

Pyrophosphate and Arterial Calcification in Chronic Kidney Disease

Arterial calcifications start at early stages of chronic kidney disease (CKD) and are associated to cardiovascular mortality. Pyrophosphate (PPi) is an endogenous compound, which stops the mineralization process in bones and is expected to act at ectopic sites. In uremic rats, low PPi plasma levels are associated with high calcium content in the aorta and peritoneal administration of PPi blocks this process. People on maintenance dialysis or kidney transplant recipients have low plasma levels of PPi and show high scores of arterial calcification. The purpose is to determine the role of low PPi in the development of arterial calcifications in patients with CKD stage 3 or 4. To that aim, 252 patients with eGFR between 59 et 20 ml/min/1,73 m2 will be recruited and will be examined at baseline and three years later.

American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)

Despite many advances in our understanding of the natural history and progression of chronic kidney disease (CKD) and cardio vascular disease (CVD) in the parent CRIC study over the past 15 years, important questions about key risk factors for these diseases remain unanswered in the AI population. To address this burden of CKD in AI communities Investigators formed a consortium of investigators with extensive experience in conducting research of chronic diseases including diabetes, cardiovascular and kidney disease in AIs of Southwestern US. The proposed CRIC ancillary cohort study of 500 AIs (AI-CRIC) will rapidly improve our understanding of both potential risk factors for CKD progression, as well as the scope of this disease among AIs. This study leverages the current CRIC study and incorporates the planned activities of the next phase of the study - "CRIC 2018" - by implementing contemporary CRIC protocols for kidney and cardiovascular measurement and outcomes.

Effects of Brazil Nut Supplementation in Patients With Chronic Kidney Disease Undergoing Conservative Treatment

The aim of this study is to evaluate the effects of Brazil nut supplementation on inflammation, oxidative stress and intestinal microbiota in patients with chronic kidney disease undergoing conservative treatment.

Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease

This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with chronic kidney diseases (CKD) and Systemic arterial hypertension (SAH), in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months.

Beetroot Extract Supplementation Associated With an Exercise Protocol for Chronic Kidney Disease Patients

Chronic kidney disease (CKD) patients often present systemic inflammation and oxidative stress, resulting in metabolic disorders and high rates of disease-associated cardiovascular death. The literature has indicated that dietary control, the use of bioactive compounds, and the practice of regular physical exercise are essential for the prevention and management of CKD and its complications. In this context, beetroot (Beta vulgaris rubra) deserves attention as it is a source of several bioactive compounds, such as nitrate, betaine, and betalain, with beneficial effects for CKD patients, including anti-inflammatory, antioxidant effects, reduction of blood pressure, and vasodilatory action. The antioxidant and anti-inflammatory properties, in addition to their vasodilatory and antihypertensive capacity, can make supplementation of beetroot an excellent nutritional strategy to help in the treatment of CKD patients. So, this research project will bring contributions to the scientific world, providing strategies for application in clinical practice and the care of patients with CKD, on the use of beetroot associated with an exercise protocol as a non-pharmacological strategy in modulating inflammation, oxidative stress, and improved functional capacity. Furthermore, when supplemented hours before physical training, has been identified as an important factor in improving performance in these activities. Therefore, this study aims to evaluate the effects of supplementation (acute and chronic) of beetroot extract associated with an exercise protocol on complications associated with CKD.

Effects of Cinnamomum Supplementation in Chronic Kidney Disease Patients

Patients with chronic kidney disease (CKD) experience many complications related to inflammation and oxidative stress that are closely related to the progression of kidney failure and increased mortality. Furthermore, these patients may have intestinal dysbiosis associated with persistent uremia, generating greater production of uremic toxins arising from the metabolism of intestinal bacteria and also helping to maintain the inflammatory process and oxidative stress. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation and improve the antioxidant response of patients with CKD, and even more so to modulate the intestinal microbiota. Based on the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation, oxidative stress, and also the modulation of the intestinal microbiota, cinnamon, a member of the Lauraceae family, has been widely used as a spice and traditional herbal medicine for centuries and has indicated beneficial benefits in cardiovascular diseases, obesity, diabetes. The bioactive compounds in cinnamomum, such as cinnamaldehyde, cinnamic acid, and cinnamate, can attenuate oxidative stress, inflammation, hyperglycemia, intestinal dysbiosis, and dyslipidemia, which are common complications in CKD patients. Therefore, the present project proposes a longitudinal clinical trial study that aims to evaluate the effects of cinnamomum on transcription factors and inflammatory markers, oxidative stress and modulation of intestinal health in patients with CKD on hemodialysis.

Effects of Jaboticaba (Plinia Cauliflora) Supplementation in Chronic Kidney Disease Patients

The increase prevalence of chronic kidney disease (CKD) over the years represent a significant public health problem. The role of inflammation and oxidative stress in the pathophysiology of CKD, as well as progression and comorbidities, is already well consolidated. The gut microbiota composition imbalance may also be a risk factor contributing to the increased conditions mentioned above, and to uremic toxins release and endotoxemia. The literature has indicated the use of bioactive compounds as a nonpharmacological treatment strategies for the management of non-communicable diseases (NCDs), such as CKD and its complications. In this context, jaboticaba (Plinia Cauliflora) emerges as a potential therapeutic approach as it is a source of phenolic compounds, such as anthocyanins, flavonols, ellagitannins, and phenolic acids. Such phenolic compounds may have beneficial effects in patients with CKD, such as anti-inflammatory, antioxidant, modulation of the intestinal microbiota, hypotensive and hypoglycemic effects. These combined effects can help manage risk factors and CKD itself, and associated complications. Therefore, this research project aims to add scientific knowledge, providing a non-pharmacological therapeutic approach to be implemented in clinical practice and in the care of patients with CKD, with the aim of modulating inflammation, oxidative stress, microbiota composition, and improving the quality of life of these patients. Therefore, this study aims to evaluate the effects of jaboticaba (Plinia Cauliflora) supplementation on complications associated with CKD.

Strategies for Kidney Outcomes Prevention and Evaluation - The SKOPE Study

Background: Chronic kidney disease (CKD) is a major public health threat associated with significant morbidity, high mortality, and reduced quality of life. However, empirical evidence is limited on strategies to enhance the effectiveness of care for CKD. The objective of the trial is to evaluate the effectiveness and cost-effectiveness of multicomponent primary care strategies in preserving kidney function among patients with CKD at primary care clinics in Singapore. Methods: A pragmatic, randomized controlled trial, in 4 socioeconomically diverse primary care clinics (polyclinics) in Singapore over 3 years. A total of 896 participants with CKD Stage 3 or worse aged ≥40 and \<80 years will be enrolled, with 224 from each polyclinic. Participants enrolled in each polyclinic will be randomly allocated to the intervention or usual care group in a 1:1 ratio. Intervention includes four components 1) training nurses as health coaches for motivational conversation and CKD specific lifestyle counseling on diet and exercise, using hybrid follow-up approach of in-person, telephone, and secure WhatsApp video meetings; 2)Training physicians in algorithm-based standardized management of CKD and hybrid care delivery;3) subsidy on sodium-glucose transport protein-2 inhibitors (SGLT-2i) for CKD; and 4) regular CKD case review meetings. Patients in the usual care arm will be treated by physicians and nurses who and are not trained in SKOPE treatment algorithms. Study outcomes: The primary outcome will be the eGFR total slope from randomization to final follow-up at 36 months. secondary effectiveness outcomes will be 1) Change in CVD risk score as measured by The Million Hearts Longitudinal ASCVD Risk Assessment score 2) Change in CKD quality of life measured by KDQOL-36TM

SPYRAL GEMINI Pilot Study

The purpose of the SPYRAL GEMINI Pilot Study is to evaluate that multi-organ denervation with the Gemini System is safe and provide evidence of blood pressure reduction when studied in an uncontrolled hypertensive population with and without high cardiovascular risk.

Safety and Efficacy of Finerenone in Metabolic Dysfunction Associated Steatotic Liver Disease(MASLD/NAFLD) Related Cirrhosis Patients With Ascites in Prevention of Chronic Kidney Disease.

Renal dysfunction is a frequent and clinically important complication in cirrhosis, and MASLD/NAFLD is associated with increased risk of incident CKD; however, finerenone has not been specifically studied in MASLD-cirrhosis populations despite proven cardiorenal benefits in diabetic CKD. This monocentric, open-label, randomized controlled trial at the Department of Hepatology, ILBS, New Delhi will enroll 160 adults (18-80 years) with MASLD/NAFLD cirrhosis, clinical grade I-II ascites, and stable eGFR ≥60 mL/min/1.73 m² (MDRD-6), with key exclusions including CTP class C, refractory ascites, significant coagulopathy, intrinsic kidney disease, recent major cardiovascular events, and other protocol-defined contraindications. Participants will receive standard medical treatment (dietary measures, diuretics as indicated, metabolic control, complication management, albumin/beta-blockers as needed) and will be randomized to finerenone (5 mg/day uptitrated to 10-20 mg/day) versus spironolactone (50 mg/day uptitrated to 100-200 mg/day). The primary endpoint is incident CKD at 6 months , defined as sustained eGFR \<60 mL/min/1.73 m² over 3 months. Secondary endpoints include MAKE/MACE/MALO at 6 months, drug-related adverse events (including hyperkalemia, hyponatremia, hypotension, hyperuricemia), AKI/AKD episodes, renal biomarkers (e.g., cystatin C, UPCR), ascites response, liver severity scores (MELD 3.0/MELD-Na/CTP), and metabolic/inflammatory/endothelial markers (e.g., HbA1c, HOMA-IR, hsCRP, vWF). Sample size (n=160; 80/arm) is powered to detect an absolute 20% reduction in CKD progression (35% to 15%) with 80% power and 5% alpha (10% dropout), with intention-to-treat analyses including Kaplan-Meier and Cox regression methods.

Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication

The study is a- 2-arm randomized controlled trial among patients presenting for kidney transplant evaluation at a single transplant center to compare the effects of a patient-based self-learning and outreach intervention about living-donor kidney transplantation (KidneyTIME) versus usual care for living-donor kidney transplant knowledge, concerns, readiness, access behaviors, and living-donor inquiries over 12 months follow-up. Following consent and baseline assessment, participants were randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME intervention and usual care.

Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease

Research question: Can multiparametric renal Magnetic Resonance Imaging (MRI) provide structural and functional assessment of the kidneys to deliver prognostic information and guide treatment options in chronic kidney disease (CKD)? Aims and objectives: 1. To establish a multiparametric renal MRI protocol in CKD cohorts. 2. To use multiparametric MRI to characterise people with and without CKD progression. 3. To compare multiparametric renal MRI with 'gold-standard' renal biopsy to determine pathological processes of CKD progression that are detectable by MRI.

Evidence Based Mental Wellness Programming Online for Adults Across Chronic Physical Conditions

Chronic physical conditions are defined as conditions that require ongoing management and treatment over extended periods of time. Chronic physical conditions are not only leading causes of death and disability in North America but they are commonly associated with mental distress and reduced quality of life. Online mind-body wellness programming ranging from physical activity to mindfulness interventions has been shown to be effective in improving mental wellness in a variety of chronic disease populations, but there is a need to evaluate scalable ways to deliver these programs. Building upon a previously developed online wellness program for inflammatory bowel disease (IBD) and primary biliary cholangitis (PBC), the research team has developed a mind-body wellness program for adults ≥18 years of age living with different chronic conditions (e.g., cirrhosis, PBC, heart failure). The 12-week program will be delivered online, and include follow- along mindful movement, breathwork and meditation routines, and a psychology based coping skills program. In a three-armed randomized controlled trial, the study will assess the impact on the primary outcome of anxiety and depression as measured through the hospital anxiety and depression scale (HADS). At the beginning and the end of the 12-week research study, participants will complete surveys to assess secondary/exploratory outcome measures including quality of life, fatigue, frailty, demoralization, and healthcare usage. After the program, the research team will conduct interviews with participants to allow them to share their other feedback about the program. The researchers will also send surveys to the participants eight weeks after the program ends to assess longer- term impacts on primary and secondary outcomes.

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension

The purpose of the SPYRAL SWYFT sub-study is to evaluate whether renal denervation with the Symplicity Spyral system performed in the main and first order branch renal arteries yields a shorter procedure time and is as effective in reducing blood pressure than the procedural approach used in the SPYRAL HTN-ON MED and SPYRAL PIVOTAL - SPYRAL HTN-OFF MED clinical studies in an uncontrolled hypertensive population.

Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD

Skeletal muscle metabolic health is critical for mobility and an underrecognized target of metabolic acidosis in chronic kidney disease. Impaired muscle mitochondrial metabolism underlies poor physical endurance increasing the risk of mobility disability. The proposed project will use precise in vivo tools to study the pathophysiology of poor physical endurance in a clinical trial treating metabolic acidosis among persons living with chronic kidney disease.

Dapagliflozin on Renal Morphology and Renal Perfusion in Patients One Year After Kidney Transplantation

The aim of this study is to observe the mechanisms of dapagliflozin on the renal interstitial tissue and renal perfusion. For this purpose, renal transplanted patients as an excellent model of CKD and high cardiovascular risk (similar to patients in DAPA-CKD study) are included in this study. The objectives of the study are to analyze the effects of dapagliflozin on renal morphology and renal perfusion in patients with impaired renal function one year after kidney transplantation. This is a randomized (1:1), single centre clinical study. Each patient will be randomly assigned in an unblinded fashion to 10 mg Dapagliflozin or not 9 months after transplantation. At least 48 patients will be randomized and included. The routine renal biopsy taken one year after kidney transplantation will allow us to determine the morphological integrity of peritubular fibroblasts, interstitial inflammatory cell density and investigate markers of inflammation, oxidative stress and nitic oxide synthase expression (iNOS).

Chronic Kidney Disease Registry Platform Study

This is a multicenter, prospective, observational registry platform study which is designed to establish a CKD registry platform by collecting data on the demographics, etiology and staging, clinical characteristics, diagnostic and treatment patterns, and clinical outcomes of patients with chronic kidney disease (CKD), to describe the current status of the diagnosis and treatment of patients with CKD and the gaps from the diagnostic and treatment guidelines, explore the risk factors for disease progression and clinical outcomes in CKD patients, and construct a risk prediction model for CKD progression and clinical outcomes

Chronic Kidney Disease-Education (CKD-EDU)

The investigators are conducting a study to see which program better helps older patients with kidney disease choose their treatment. Investigators are also investigating if either program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults. Half of the participants will receive Program A, while the other half will receive Program B. Investigators will compare the two groups to see which participants feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits and hospital admissions. Participants in Program A will receive information from the National Kidney Foundation and meet with a kidney therapy educator. Participants in Program B will get information about kidney disease treatment and meet with a decision-support specialist who's an expert in decision-making.

SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN

The purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system in subjects treated with renal denervation. Additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the SPYRAL PIVOTAL-SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED studies.

NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities

The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for individuals with CKD. The investigators hypothesize that the multilevel NAVIGATE-Kidney program intervention will reduce the rate of central venous catheter use at KRT start (primary outcome), increase the rate of optimal KRT starts (secondary outcome), increase patient activation, and reduce decisional conflict (patient-centered outcomes) for individuals with advanced CKD. The project will have four (4) aims.

Immunogenicity of HPV Vaccine in Transplant Recipients.

To measure levels of HPV antibodies in post-solid-organ transplant recipients who have gotten the HPV9 vaccine.