Clinical Research Directory

Effect of Synbiotic Therapy on Renal Function Outcomes in Patients With Chronic Kidney Disease Stage III-IV: A Double-blind Randomized Placebo-controlled Trial.

Background: Chronic kidney disease (CKD) represents a growing global public health challenge, with rising prevalence in low and middle-income countries, including Bangladesh. Progressive renal dysfunction is frequently accompanied by gut microbiota alterations, leading to increased intestinal permeability and systemic inflammation through the gut-kidney axis. Accumulation of uremic toxins derived from dysbiotic microbiota has been implicated in CKD progression. Synbiotic therapy, combining probiotics and prebiotics, has been proposed as a strategy to restore microbial balance and reduce inflammatory burden. Objective: To evaluate effect of Synbiotic Therapy on Renal Function Outcomes in Patients with Chronic Kidney Disease Stage III-IV. Materials and Methods: This Double-blind, randomized placebo-controlled trial will be conducted in the Department of Nephrology, Chittagong Medical College Hospital, Bangladesh. Approximately 96 adult non-dialysis CKD stage III-IV patients will be enrolled. Participants will be randomly allocated into two arms of treatment. The experimental arm and the control arm. Both arm with receive standard care according to KDIGO recommendations. The experimental arm will receive synbiotic therapy and the control arm with receive placebo in addition to standard therapy. Clinical and laboratory assessments will be performed at baseline, after 1.5 months and after 3 months. Outcome measures are change in S. Creatinine, e-GFR, Blood Urea Nitrogen (BUN), C-Reactive protein (CRP), and Gastrointestinal symptom dynamics using Gastrointestinal System Rating Scale (GSRS). Data Analysis Plan: An intention-to-treat or per protocol approach will be applied as applicable. Parametric or non-parametric tests will be applied as appropriate. Repeated-measures analysis will assess longitudinal changes. Conclusion: The expected findings may clarify the potential role of gut microbiota modulation as an adjunct in CKD management in Bangladesh and similar settings and may inform future multicenter trials.

AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring

The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with chronic kidney disease (CKD). Study objectives are: * Arm 2A (Outpatient Diagnostic Accuracy): To generate a preliminary, real-world signal of the diagnostic performance of AK+ Guard™ when used in an ambulatory CKD cohort for identifying clinically significant hyperkalemia episodes (serum K+ ≥ 6.5 mmol/L) at the time of an outpatient laboratory draw. * Arm 2B (Remote Patient Monitoring): To assess participant compliance, usability, and end-to-end system reliability of AK+ Guard™ when deployed for daily remote monitoring of CKD patients outside the clinical environment for up to four weeks.

Impact of Mindfulness on Pain In SA

Background: Patients with end-stage renal disease (ESRD) undergoing hemodialysis often experience chronic pain, maladaptive pain cognitions, and diminished quality of life, yet evidence on mindfulness-based interventions (MBIs) in Middle Eastern dialysis populations remains limited. Objective: This trial evaluated the effectiveness of a five-week mindfulness meditation program on pain severity, pain catastrophizing, quality of life, and trait mindfulness in hemodialysis patients. Methods: A randomized controlled trial with a pre-post design was conducted with 38 adults on maintenance hemodialysis at Dr. Soliman Fakeeh Hospital, Jeddah (19 intervention, 19 control). The intervention group received 30-minute mindfulness meditation sessions three times weekly during dialysis for five weeks; the control group received standard care. Outcomes were assessed at baseline and post-intervention using the Numeric Rating Scale (NRS), the Pain Catastrophizing Scale (PCS), the Kidney Disease Quality of Life Short Form (KDQOL-36), and the Mindful Attention Awareness Scale (MAAS). A 2×2 mixed-design analysis of variance (ANOVA) compared change over time within and between groups.

Metabolic Status and Risk of Chronic Kidney Disease in French Overseas Populations With Morbid Obesity (OBECAMcohort).

Morbid obesity is defined by a body mass index (BMI) ≥ 40 kg/m2 or \> 35 if there is at least one comorbidity (hypertension, diabetes, hypercholesterolemia, joint pain, obstructive sleep apnea syndrome, etc.) Morbid obesity significantly increases the prevalence of comorbidities, such as cardiovascular and metabolic diseases, chronic kidney disease (CKD), cancers, etc. . The main objective is to assess, at 5 years, the incidence (or progression) of CKD, depending on the presence or absence of Metabolic Syndrome ( a combination of several cardiovascular risk factors), in 2 overseas populations (Caribbean and Polynesian) with morbid obesity. We also aim to estimate at 5 years the incidence of complications other than CKD: metabolic diseases (diabetes, dyslipidemia), cardiovascular diseases (coronary artery disease, stroke) and death in the cohort and to evaluate the association between gene variants linked to central adiposity and/or CKD and the occurrence of events. The risk factors to study are \- Metabolic syndrome (MetS) and its components MetS define by presence of at least 3 of the following criteria: * Waist circumference ≥ 102 cm in men and ≥ 88 cm in women * Systolic blood pressure ≥ 130 and/or diastolic ≥ 85 mmHg * HDL-cholesterol \< 1.04 mmol/L (40 mg/dL) in men, \< 1.29 mmol/L (50 mg/dL) in women * Triglyceridemia ≥ 1.69 mmol/L (150 mg/L) * Fasting blood glucose ≥ 5.6 mmol/L (100 mg/dL) * Environmental and behavioral factors The design of the study * A Descriptive and comparative cross-sectional study, to i) describe the natural history of the disease, ii) estimate the prevalence of factors of interest, iii) make comparisons between groups, according to different parameters (including ethnicity). * A Longitudinal study with evaluation of the incidence of complications and deaths in the cohort. The global Number of patients to include is : 480: (and 240 in Guadeloupe and 240 in French Polynesia) The Inclusion criteria are: Individuals with a BMI ≥ 40 kg/m2 or \> 35 if there is at least one comorbidity. Aged 18 to 76 years. Of both sexes. Having given their written consent. Without a history of bariatric surgery or having benefited from this intervention for more than 5 years The statistical analysis method includes: * A descriptive analysis for all parameters of interest, for all groups: Incidence of cardiovascular, metabolic and CKD complications Incidence of deaths * Comparisons between groups * Logistic regressions for * Measuring the association between MetS and complications * Measuring the association between gene variants,MetS, CKD and other complications. * COX proportional hazards models to specify the risk of occurrence of CKD and other complications and the risk of mortality, taking into account in particular MetS, the duration of follow-up A better understanding of some clinical, metabolic and genetic aspects of morbid obesity and/or its complications is expected as well as benefits in terms of disease management. Start of inclusions: March 3, 2025 End date of monitoring: December 31, 2030

Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.

We propose the following hypotheses: * The use of herbal medicine is common among patients with chronic kidney disease in Réunion island. * This use could influence the progression of kidney disease in these patients. To assess the primary inclusion criterion, patients will be easily identified by nephrologists through existing follow-up. The questionnaires will be administered after this early identification by the investigators at each center. The primary evaluation criterion is straightforward: it aims to establish an overview of the use of herbal medicine in our patient population. This information is currently unavailable and remains crucial for measuring the extent of the issue. Our secondary criteria will involve more in-depth analysis of this use and an attempt to correlate the use of certain herbs with the rate of progression of kidney disease at one year. We targeted patients with moderate to end-stage chronic kidney disease (KDIGO classification 3 to 5), which are the stages typically included in kidney disease studies. Furthermore, these patients are the most likely to experience a greater annual progression of their kidney disease, and the effect of herbs on this progression could be investigated. Transplant patients were not included because they are more aware of the risks of not using herbal medicine due to their use of immunosuppressants.

Effects of Maqui Supplementation on Gut Microbiota, Inflammation, and Oxidative Stress in Patients With Chronic Kidney Disease

Chronic kidney disease (CKD) is a highly prevalent condition in Chile and worldwide and is associated with a substantial burden of morbidity, particularly cardiovascular morbidity. In the early stages of CKD, treatment aims to preserve kidney function and slow the progression of associated complications. Several conditions have been reported in association with CKD, including impaired antioxidant capacity, inflammation, and alterations in the gut microbiota (GM), which contribute, among other complications, to the loss of kidney function and cardiovascular damage. In the search for therapeutic approaches to modulate CKD-related complications, there is growing interest in complementary non-pharmacological interventions, including nutritional strategies within the "Food as Medicine" concept. In this context, maqui remains largely unexplored in CKD. Maqui contains phenolic compounds with bioactive properties and strong antioxidant activity, which have also been associated with anticancer, antimicrobial, and anti-inflammatory effects, as well as inhibition of enzymes involved in metabolic syndrome, making this fruit of particular interest for human health. To date, no studies have evaluated the therapeutic potential of maqui in relation to oxidative stress, inflammation, gut microbiota, and CKD progression, or whether these biomarkers and the response to maqui supplementation differ according to biological sex. To evaluate the effects of maqui supplementation in men and women on the modulation of gut microbiota, inflammatory parameters, and oxidative stress in patients with stage 3 and 4 chronic kidney disease. A longitudinal, randomized, double-blind clinical trial will be conducted in patients with CKD recruited from healthcare centers in the Metropolitan Region of Santiago, Chile. Participants will receive either a dietary supplement containing dried maqui extract in powder form, equivalent to 200 mg of Delphinol, or placebo for three months. At baseline and after three months of intervention, gut microbiota composition, uremic toxins, inflammatory and oxidative stress markers (plasma antioxidant capacity, urinary polyphenols, IL-6, high-sensitivity C-reactive protein \[hs-CRP\], NGAL, and uremic toxins), parameters of CKD progression, and anthropometric and dietary parameters will be assessed.

Equol and Vascular Function in Women With Chronic Kidney Disease

The risk of cardiovascular disease (CVD) is significantly elevated in patients with chronic kidney disease (CKD). Notably, women with CKD commonly experience menstrual disturbances induced by CKD, which may contribute to impaired vascular function and elevated CVD risk. However, most of the literature in nephrology focuses on male patients, and studies on women's vascular health are limited. Establishing effective therapies for improving vascular function and reducing CVD risk in women with CKD is a high research priority of the NIH. Equol contributes to improvement in vascular function, mediated in part by its anti-oxidative and anti-inflammatory properties. However, there is no information on the effect of equol on vascular function in women with CKD. The proposed project aims to determine the effect of 12 weeks of oral equol supplementation on vascular function in postmenopausal women with CKD.

Screening for Cardiac and Cardiac-associated Pathology Using Single-channel Electrocardiogram

It is a prospective, controlled, single-center, observational, non-randomized study. The study is planned to include at least 4000 patients 18 years old and older in the training sample and 1000 patients over 18 years old in the test sample (the total number of patients is at least 5000 people). Patients will be included in the study if they have undergone a full examination (laboratory, clinical and instrumental), allowing for the verification or exclusion of cardiac and cardiac-associated pathology in accordance with current recommendations. During the course of the study, the authors of the work do not interfere with the above-mentioned scope of the examination, which is carried out on patients in accordance with clinical guidelines. All patients included in the study will undergo ECG recording in standard lead I for 1 minute twice, followed by spectral analysis of the obtained data, which will be stored at the remote monitoring center of Sechenov University without being linked to the personal data of patients. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform. The result of this study will be the identification of ECG parameters that will correlate with cardiac and cardiac-associated pathology

Safety and Efficacy of SC101 Via Perirenal Fat Injection for Resistant Hypertension in Patients With Moderate to Severe Chronic Kidney Disease

This is a single-center, open-label, exploratory clinical study designed to evaluate the safety and efficacy of a single-session injection of SC101, a small interfering RNA (siRNA) agent, into the perirenal fat. This study plans to enroll 3 participants, aged 18 to 65 years, who have a clinical diagnosis of resistant hypertension and moderate to severe chronic kidney disease (CKD).

Phosphate Assessment in Chronic Kidney Disease Patients Study

The proposed pilot feeding study aims to explore novel pathways in phosphate metabolism and identify new biomarkers, as well as to develop a compound index for assessing phosphate overload with high validity and reliability. Investigators will address the following specific aims: 1). To explore novel pathways of phosphate metabolism and assess the influence of CKD status on these metabolic pathways. 2). To identify novel biomarkers for phosphate overload that reflect changes in dietary phosphorus intake. 3). To develop a compound phosphate overload index that measures dietary phosphorus intake with high validity and reliability. This study will provide novel insights into phosphate metabolism and the assessment of phosphate overload in CKD patients. This investigation aims to provide preliminary data to further studies for the development of reliable biomarkers in CKD patients, which could contribute significantly to early interventions and improve health outcomes.

ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases

This study investigates the safety and efficacy of ACE Reno, an oral transmucosal solution containing standardized bioactive peptides and amino acids, in patients with nephropathy of various etiologies and stages. The trial evaluates whether 12 weeks of ACE Reno (1 mL sublingually four times daily) reduces albuminuria/proteinuria and stabilizes kidney function in participants with nephropathy due to diabetes, hypertension, autoimmune disease, reflux/UTI, chronic glomerulonephritis, unknown etiology, pre-dialysis CKD, or post-transplant proteinuria. Nephropathy remains a global health burden, with \~9-10% of the population affected by chronic kidney disease (CKD), equating to \>750 million individuals worldwide. The socioeconomic costs are substantial: in England CKD costs \~£7 billion annually, projected to rise to \~£14 billion by 2033; in Malaysia, prevalence rose from 9% to 15.5% within 7 years; in Egypt, CKD imposes heavy familial and financial burdens, especially for pediatric patients; in Turkey, CKD is among the top causes of disability, linked to the rising tide of diabetes, obesity, and hypertension. ACE Reno is designed to address multiple drivers of CKD progression - glomerulosclerosis, fibrosis, endothelial dysfunction, and maladaptive RAAS/aldosterone signaling - through its peptide components that mimic antifibrotic (BMP-7, HGF, Klotho-like) and vasodilatory/cGMP-mediated (natriuretic peptide-like) pathways.