Clinical Research Directory

SDCC - Prospective Cohort Study of Chronic Renal Insufficiency

Chronic kidney disease (CKD) is a silent epidemic affecting more than 37 million Americans. The burden of morbidity and mortality associated with CKD derives from its frequent progression to end-stage kidney disease (ESKD) and the disproportionate risk of cardiovascular disease (CVD) and associated complications. CKD is strongly and independently associated with CVD, even after adjustment for traditional CVD risk factors. This led to the hypothesis that other risk factors augment the rate of CVD in the setting of CKD. Hence, many patients with progressive renal disease succumb to fatal CVD events before they need renal replacement therapy. The National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) established the Chronic Renal Insufficiency Cohort (CRIC) Study in 2001 with the initial goal of elucidating the relationship between CKD and CVD. Since its inception, the CRIC Study has recruited and followed a racially and ethnically diverse cohort of over 5,000 participants with reduced kidney function from 13 clinical recruitment sites across the US. The original aim of CRIC was to establish a clinical research laboratory designed to (a) identify novel predictors of CKD progression, and (b) characterize the manifestations of CVD and identify its risk factors among individuals with CKD. The CRIC Study has examined a broad set of etiological factors (clinical, behavioral, and biomarker-associated) potentially responsible for both progressive CKD and CKD-related morbidities, especially those early in the course of CKD. Characterizing relationships between these risk factors and outcomes should facilitate identification of high-risk subgroups with CKD and guide enrollment into preventive treatment trials and application of preventive therapies. Over time, the scientific focus and the CRIC investigator network have broadened extensively through a highly successful ancillary studies program that has included more than 100 projects, most of which have been funded through federal grants. To date, the CRIC Study's investigative activities have resulted in over 300 published scientific papers with many additional manuscripts in development.

Acute Kidney Injury Genomics and Biomarkers in TAVR Study

In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.

AI-Guided Personalized Relaxation for Hemodialysis Patients

Patients undergoing maintenance hemodialysis frequently experience impaired health-related quality of life, anxiety, and difficulties in coping with the long-term demands of treatment. Artificial intelligence (AI)-guided interventions may provide personalized psychological support and promote adaptive coping through tailored relaxation strategies. This randomized controlled mixed-methods trial evaluates the effectiveness of an AI-guided personalized relaxation intervention delivered through a smartphone application among adults receiving maintenance hemodialysis. Participants are randomly assigned to either an intervention group receiving AI-guided personalized relaxation in addition to routine hemodialysis care or a control group receiving routine care alone. The 6-week intervention includes individualized breathing exercises, mindfulness practices, guided imagery, progressive muscle relaxation, and adaptive feedback generated according to participant characteristics, emotional responses, and engagement patterns. The primary outcome is health-related quality of life measured using the Kidney Disease Quality of Life-36 (KDQOL-36™). Secondary outcomes include anxiety symptoms measured by the Generalized Anxiety Disorder-7 (GAD-7), coping strategies measured by the Brief COPE Inventory, and user acceptance of the AI-guided intervention. Qualitative interviews are conducted with intervention participants to explore their experiences, perceived benefits, feasibility, and acceptability of the intervention. The study aims to determine whether AI-guided personalized relaxation can improve quality of life, reduce anxiety, and enhance coping among patients undergoing maintenance hemodialysis while providing insight into the acceptability and feasibility of integrating AI-supported psychosocial interventions into routine dialysis care.

Comparing The Effect Of Empagliflozin With Dapagliflozin In Reducing Proteinuria In Diabetic Patients With Chronic Kidney Disease With eGFR More Than 45ml/Min/1.73m²

This study was designed to compare empagliflozin and dapagliflozin in reducing protein leakage into the urine in adults with type 2 diabetes and chronic kidney disease. It examined whether the two medicines differed in their effects on urine protein levels. Blood sugar control, kidney function, treatment costs, and side effects were also selected for comparison. The study was planned as a randomized controlled trial at the Nephrology Department of Lahore General Hospital, Lahore, Pakistan. The planned sample comprised 116 men and women aged 20-70 years who had increased urine albumin levels and an estimated glomerular filtration rate, a measure of kidney filtration, above 45 mL/min/1.73 m². Participants were to be assigned by a lottery method to two equal groups of 58 patients. One group was to receive dapagliflozin 5 mg once daily, and the other empagliflozin 10 mg once daily. Assessments were scheduled before treatment and after two and four months. The main assessment was the change in the urine albumin-to-creatinine ratio, which measured the amount of albumin, a blood protein, leaking into the urine. Other assessments included blood tests for kidney function and average blood sugar levels. Treatment costs and side effects, including low blood sugar, urinary tract infections, oral thrush, dehydration, allergic reactions, body pains, and kidney failure, were also included in the follow-up plan. The study aimed to compare the benefits, safety, and costs of these treatments in the selected patients.

A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event

The purpose of this study is to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with placebo in adults who have elevated hsCRP and at increased risk for cardiovascular event. Participation in the study will last about 9 months.

Comparison of the Effect of Allopurinol Versus Febuxostat on Serum Uric Acid in Patients With Chronic Kidney Disease Associated With Hyperuricemia

This randomized study was designed to compare how well allopurinol and febuxostat lowered blood uric acid in adults with chronic kidney disease and high uric acid levels. It was planned to include 66 participants, aged 18 to 65 years, with stage 3 to 5 chronic kidney disease. Participants were to be assigned to receive either febuxostat 40 mg daily or allopurinol at a dose adjusted for their level of kidney function. Treatment was planned for eight weeks, with follow-up visits at weeks 4 and 8. The researchers hypothesized that the two medicines would differ in their effects after eight weeks. The main measure was the proportion of participants whose uric acid level reached below 6.0 mg/dL. Changes in uric acid levels and estimated kidney function were also to be compared.

A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)

The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.

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).

Improving Health Literacy on Chronic Kidney Disease Among Diabetics: the Malaysian Nutritional, Emotional and Physical Health Literacy for Optimal Renal Outcome (My-NEPHRO) Trial

The goal of this clinical trial is to learn if a health literacy module via mobile application intervention can improve health outcomes and health literacy in diabetics with chronic kidney disease and could include any of the following: diabetic patients with non-dialysis chronic kidney disease aged more than 18 years old. The main questions it aims to answer are: 1. Are there differences in health literacy between intervention and control group at pre- and post-3 and 6 month exposure to the health literacy module in both intervention and control groups 2. Are there differences in quality of life scores between intervention and control group at pre- and post-3 and 6 month exposure to the health literacy module in both intervention and control groups? 3. Are there differences in renal function(eGFR) and HbA1C in pre- and post- 6 month exposure to the health literacy module between the intervention and control groups? Researchers will compare with normal care to see whether the effect of this intervention is larger than the effect of usual care in improving health literacy and HbA1c level, and impact towards renal disease progression and quality of life in diabetics with chronic kidney disease. Participants will be instructed to access the mobile application weekly.

Effects of Exogenous Ketosis on Proteinuria and Renal Function

A randomized, placebo-controlled, double-blinded crossover study will be conducted. Fourteen patients with polycystic kidney disease (PKD) and 29 patients with proteinuric kidney disease will receive ketone bodies (Ketone-IQ) and placebo in a randomized order. Each treatment period is four weeks. There will be a wash-out period of two weeks in between treatment periods. Effect variables will be measured in the last day of each treatment period.

Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP

The goal of this clinical trial is to compare a new intravenous drug, Anruikefen, with a traditional oral medication, nalfurafine orally disintegrating tablets, in improving sleep quality in patients with chronic kidney disease-associated pruritus. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI). The study will also evaluate the safety of Anruikefen. The main questions it aims to answer are: * Does Anruikefen injection improve sleep quality better than oral nalfurafine? * Does Anruikefen injection improve patients' quality of life more than oral nalfurafine? Researchers will compare Anruikefen with nalfurafine (an active control drug) to evaluate differences in their effects on sleep quality in patients with chronic kidney disease-associated pruritus. Participants will: * Receive either Anruikefen injection (0.3 μg/kg, three times per week) or nalfurafine hydrochloride orally disintegrating tablets (2.5 μg once daily). * Continue treatment for 4 weeks, followed by a 1-week safety follow-up. * Complete the Pittsburgh Sleep Quality Index and other quality-of-life questionnaires after one month.

Potassium Supplementation in CKD

The current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate \[eGFR\] 15 - 45 ml/min/1.73 m2).

Living With Chronic Kidney Disease Without Renal Replacement Therapy: Experience of Women of Childbearing Age

Chronic kidney disease (CKD) affects approximately 13% of the global population. This condition is often associated with comorbidities such as diabetes and hypertension. Although its prevalence increases with age, CKD can also affect younger individuals, particularly women of childbearing age. From the early stages, CKD may lead to female-specific clinical manifestations, such as reduced fertility, occurring at a key period of life. These clinical aspects may also be accompanied by concerns about the transmission of hereditary nephropathy and may generate a significant psychological burden. However, current knowledge regarding the lived experience of young women of childbearing age with CKD remains limited, particularly in France. The main objective of this study is to explore the lived experience of young women with CKD who are not receiving kidney replacement therapy. In this study, lived experience refers to how participants perceive, make sense of, and integrate CKD into their daily lives and future life plans. Twelve participants with CKD, not transplanted and not on dialysis, will be recruited and divided into two groups: six women with genetically determined CKD and six women with non-genetic CKD. This grouping is justified by the fact that the etiology of the disease may profoundly influence lived experience. Genetic CKD is often associated with concerns regarding familial transmission and early medical follow-up, whereas non-genetic CKD may be perceived as an acquired condition occurring later in life. Data will be collected through semi-structured interviews based on a tailored interview guide. Transcripts will be analysed using Interpretative Phenomenological Analysis (IPA), which allows exploration of the meaning that each participant attributes to her experience. This is an exploratory pilot study aiming to document, for the first time in France, the lived experience of young women with CKD, with a secondary focus on the potential impact of genetic versus non-genetic etiology. Particular attention will be given to themes related to sexual and reproductive health. The findings will contribute to a better understanding of this understudied population and may ultimately improve their clinical care.

PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program

Monocentric, randomised, controlled and open study. Subjects will be included prospectively and consecutively and randomly assigned into two groups. Intervention group A will benefit a medication adherence support program during 12 months while intervention group B during 6 months only. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visit, the pharmacist will conduct a semi-structured interview in 15 minutes based on Fisher's sociocognitive model with the patients. A summary of the interview and the adherence graph will be send to the patient' health professionals.

Supporting Self-Management of Healthy Behaviors in Diabetes, Kidney Disease, and Hypertension

The planned intervention, entitled, Supporting Self-Management of Health Behaviors to Optimize Health (SMART-HABITS for Health), aims to provide support for patients with chronic kidney disease (CKD), hypertension and diabetes by providing text messages delivered as motivational reminders and support to encourage blood pressure self-monitoring through goal setting, customized task prompts via text message and feedback, leveraging social connections, and use of a gamification design.

Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.

The selection of kidneys from living donors is based on strict glomerular filtration rate (GFR) values, in the setting of the increasing proportion of older donors. The 2017 KDIGO recommendations consider that approving kidney donation for a donor with a GFR between 60 and 89 mL/min/1.73 m² should be individually discussed, possibly using a calculator. A GFR \< 60 mL/min/1.73 m² should contraindicate donation without considering the donor's age. GFR physiologically decreases with age, so older donors frequently have a GFR below 90 ml/min/1.73 m². However, the proportion of older donors continues to rise. Kidney grafts from older living donors maintain better renal function than those from deceased donors, aiming to counteract the organ shortage. Kidneys possess functional reserves, allowing an increase in GFR during stimulations and adaptation to reduced functional nephron count (as after nephrectomy). Assessing this adaptive capacity clinically is challenging. It might be dependent on vascularization and/or absence of fibrosis, but these parameters are poorly understood due to a lack of current in vivo exploration methods. The development of functional renal MRI enables the evaluation of these parameters, allowing measurements on separate, regional, non-invasive, quantitative kidney segments coupled with morphological studies. BOLD-MRI can measure regional oxygen content, thus accessing more precise medullary data. The DWI sequence can estimate renal microstructure and study interstitial fibrosis. Therefore, evaluating renal performance (by measuring GFR, renal perfusion, fibrosis, inflammation, and oxygen content) in donors, and studying the evolution of these parameters in recipients and donors, could optimize donor selection. Hence, the aim of our study is to 1) investigate the evolution of renal functional parameters in the transplanted kidney up to 1 year post-transplant, and 2) study the evolution of these same parameters in the contralateral kidney of the donor.

Chronic Kidney Disease - Renal Epidemiology and Information Network

Preserving kidney function and improving the transition from CKD to End stage renal disease (ESRD) is a research and healthcare challenge. The Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort was established to identify the determinants, biomarkers and practice patterns associated with chronic kidney disease outcomes. The study includes 3,033 adult patients with moderate to advanced CKD from a representative sample of 40 nephrology clinics in France with respect to regions and legal status. Patients are recruited during a routine visit and followed up for 5 years, before and after starting renal replacement therapy. Patient-level clinical, biological, and lifestyle data are collected annually, as well as provider-level data on clinical practices, coordinated with the International Chronic Kidney Disease Outcomes and Practice Pattern Study (CKDopps). Blood and urine samples are stored in a biobank. The overall objective is to develop a research platform to address key questions regarding the determinants and biomarkers associated with adverse outcomes in CKD and to assess its effective management. It has the following hypotheses and specific aims: 1. to evaluate a large set of social, environmental, bioclinical, and genetic factors, and their interactions in relation with CKD outcomes including progression to ESRD, mortality, metabolic and vascular complications, and the onset of a number of chronic and acute events; 2. to assess several new biomarkers to predict adverse outcomes of CKD and its complications; 3. to evaluate the associations of provider practices (management of hypertension, anemia, nutritional abnormalities, mineral and bone disorder, nutritional status, timing of dialysis initiation and transplant wait-listing) with achievement of clinical practice guidelines, clinical and patient-reported outcomes (PRO). 4. to evaluate the associations of health care organization and clinic services (e.g., for nutrition, educational programs) with clinical and patient-reported outcomes, and achievement of clinical practice guidelines; 5. to estimate the relative cost-effectiveness of different provider practices and clinic services.

HOLT-ED: Holter-monitoring in End-stage Renal Disease

The main objective of this prospective cohort study is to assess arrhythmia burden and glycemic variability in a multicenter cohort of patients with end-stage renal disease using a sufficient observation period in order to identify arrhythmia burden and type and characterize associations with patient characteristics and dialysis treatment, glycemic variability and subsequent risk of adverse outcomes.

Neurovascular Transduction During Exercise in Chronic Kidney Disease

The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and to explore what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate). This study will also test whether or not regular exercise on a bicycle and/or treatment with 6R-BH4 (Kuvan) pills, or histidine and beta-alanine supplementation improves these measures during exercise. 6R-BH4 is currently FDA-approved for use in patients with certain forms of a disease called phenylketonuria, but it is not currently FDA approved for blood pressure or exercise capacity in people with CKD.

Time-restricted Eating in Patients With Moderate Chronic Kidney Disease and Albuminuria

Chronic kidney disease (CKD) affects approximately 12 to 15% of adults worldwide, with an increasing incidence expected. Major causes include diabetic nephropathy, hypertension, and various glomerulonephritis. Proteinuria is a key factor in identifying and assessing the risk of CKD progression. The precise pathophysiology of CKD is not fully understood, but recent research highlights metabolic alterations, particularly in lipid and glucose metabolism. CKD progression is influenced by diet, as evidenced by recent studies. Interventions such as the ketogenic diet and time-restricted feeding show promising results in improving metabolism and may have beneficial effects on CKD. Our study aims to evaluate the impact of time-restricted eating (TRE) on proteinuria, the decline in glomerular filtration rate, and weight loss in patients with moderate CKD with albuminuria (KDIGO stage 2-3). This will allow us to better understand the efficacy of this dietary approach tailored to the individual habits of participants. The primary outcome measure will be albuminuria before and after the 12-week intervention. Secondary outcome measures will include the impact of fasting on blood pressure as assessed by 24-hour ambulatory monitoring, body composition evaluated by DXA and BIA, continuous glucose monitoring, and blood hormone profiles. Additionally, the feasibility and safety of TRE in this population will be assessed.

Penn Produce Prescription and Chronic Kidney Disease Study

The goal of this pilot clinical trial is to examine the feasibility, acceptability, and likely effect of a produce prescription intervention on patient-centered outcomes, health behaviors and health outcomes, among food insecure adults with chronic kidney disease stages 3 - 5. Participants will complete surveys at three timepoints, each three months apart, and complete health measurements at two timepoints 6 months apart. Half of the participants will be randomly assigned to the treatment where they will receive produce prescriptions with amount of the vouchers depending on their reported family size, every two weeks over six months. Researchers will compare the treatment group and the control group to see if there are any improvements in patient-centered outcomes (food and nutrition insecurity, health-related quality of life, depression and anxiety) and clinical outcomes (diet quality, metabolic acidosis, serum albumin, estimated GFR, blood pressure, and HbA1C).

Exercise During Hemodialysis: Impact on Sarcopenia and Sleep Quality

Sarcopenia (the loss of muscle mass, strength, and function) is highly prevalent in patients with Chronic Kidney Disease (CKD) undergoing hemodialysis, significantly increasing the risk of falls, frailty, and mortality. Despite its impact, there is a lack of evidence regarding the effectiveness of exercise programs specifically designed to address sarcopenia under the latest international diagnostic criteria (EWGSOP2) in older renal patients. The primary objective of this randomized controlled clinical trial is to evaluate the effects of a 12-week supervised intrahospital exercise program on muscle mass, strength, and physical performance in hemodialysis patients over 40 years of age. Additionally, the study aims to analyze how this intervention influences sleep quality-often disrupted in this population-and overall health-related quality of life. Participants will be randomly assigned to either an Intervention Group, which will perform personalized strength and aerobic exercises during the first 90 minutes of their dialysis sessions, or a Control Group, receiving standard care. Evaluations will be conducted at three points: baseline (pre-randomization), at 12 weeks (post-intervention). The investigators hypothesize that integrating physical exercise into the routine clinical care of hemodialysis patients will improve sarcopenia markers and sleep patterns, leading to greater functional independence and better clinical outcomes.

Transformative Research in Diabetic Nephropathy 2.0

The goal of this observational study is to learn more about kidney health in adults with diabetic kidney disease and other groups. Researchers will study kidney tissue and other samples. They want to learn how sodium-glucose cotransporter-2 (SGLT2) inhibitors, a type of diabetes medicine, may affect the kidneys. People can join only if they are already having a kidney biopsy or kidney surgery as part of their regular medical care. The main questions this study aims to answer are: * Do people who take SGLT2 inhibitors show different biological patterns in kidney tissue than similar people who do not take them? * Are these kidney tissue patterns linked with how kidney health changes over time? Researchers will compare participants who take SGLT2 inhibitors with similar participants who do not take these medicines. Participants will: Let researchers use one stored slide of kidney tissue from their regular care (no extra research biopsy) Give a blood sample and a urine sample Let researchers review medical record information over time

Reliability of Muscle Strength and Activation Assessment Tools and Effects of an Online Therapeutic Exercise Program in Patients With Chronic Kidney Disease

This research aims to evaluate the reliability and reproducibility of muscle strength and activation measurement tools, including isokinetic dynamometry and surface electromyography, in patients with chronic kidney disease (CKD). Additionally, the study will assess the feasibility and potential benefits of an online therapeutic exercise program supervised by physiotherapists.