Clinical Research Directory

Research on Innovative Traditional Chinese Medicine Diagnosis and Treatment Technologies for Diabetic Nephropathy Driven by Multi-Omics and Artificial Intelligence

With the help of the 'Traditional Chinese Medicine Specialty Alliance Platform-Multicenter RCT Clinical Research Database,' this platform can be used to conduct scientific research on various aspects of DKD, such as disease prediction, treatment effectiveness evaluation, and recurrence rate analysis, providing effective means to improve DKD remission rates, delay disease progression, and enhance patients' quality of life. By selecting the Jiade Yishen Xiaozheng Qufang formula and conducting multicenter, prospective, double-blind RCT studies, its clinical value in improving DKD remission rates can be verified. With the support of scientific research, DKD treatment strategies can be optimized, therapeutic efficacy improved, recurrence rates reduced, and disease progression delayed, thereby enhancing patients' quality of life.

Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Therapy in Diabetic Nephropathy Patients: A Clinical Trial

The goal of this clinical trial is to evaluate the safety and efficacy of a single intra-renal injection of allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) in adults with diabetic nephropathy aged 40 to 65 years. The primary questions the study aims to answer are: 1. Is UC-MSC therapy safe and well-tolerated when administered intra-renally in patients with diabetic nephropathy? 2. Does UC-MSC therapy improve kidney function and modulate inflammatory markers over a 12-month follow-up-period? This is a single-arm, open-label, prospective clinical trial. Participants will receive a one-time intra-renal injection of UC-MSC at a dose of 1 x 10⁶ cells/kg body weight. Participants will attend scheduled follow-up visits at 1, 3, 6, 9, and 12 months post-injections for evaluation of: 1. Renal function (eGFR, serum creatinine, and urine albumin-creatinine ratio) 2. Inflammatory markers (TNF-α, IL-10) 3. Safety outcomes including early and late adverse events The results will be compared to baseline measurements to assess changes after the intervention. If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\]. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

Atrasentan in Patients With Proteinuric Glomerular Diseases

The AFFINITY Study is a phase 2, open-label, basket study to evaluate the efficacy and safety of atrasentan in patients with proteinuric glomerular disease who are at risk of progressive loss of renal function.

Research on Gut Microbiota and Metabolomics in Diabetic Kidney Disease

Diabetic kidney disease (DKD) is characterized by high prevalence, multiple pathogenesis, and lack of effective treatment and management strategies. Early detection helps overcome treatment inertia, enables timely medical intervention, maximizes renal function in diabetic patients, and is essential to avoid renal failure and improve clinical outcomes. The gold standard for diagnosis of DKD is renal biopsy, which has the highest accuracy. However, due to the trauma of renal biopsy, the patient acceptance is low, the application scenario is not universal, and it is only used when it is difficult to distinguish diabetic nephropathy from non-diabetic nephropathy, and it is not the preferred diagnostic method for DKD. In the past decade, with the emergence and application of metabonomics, proteomics, genomics and other multi-omics techniques, more and more studies have recognized the prominent role of intestinal flora disorders and gut-derived metabolites in the occurrence of DKD. Therefore, from the perspective of intestinal flora, using multi-omics techniques to identify enterogenic metabolic markers of DKD and restore intestinal flora balance may be potential strategies for prevention and management of DKD. Modern medicine believes that intestinal flora is not only closely related to diet and digestion, participating in the synthesis, absorption and metabolism of nutrients, but also constituting intestinal barrier and participating in immune defense of the body. Its function is similar to the physiological function of "The spleen governs transportation and transformation". Based on the traditional Chinese medicine（TCM） pathogenesis of DKD "Spleen Failure to Disperse Essence and Poison Damage Kidney Collateral" proposed by the previous research group, this study intends to use microbiology-metabolomics to deeply study the TCM pathogenesis of DKD, provide scientific basis for it, and guide the theory of traditional Chinese medicine widely used in clinical work of prevention and treatment of diabetic nephropathy.

Relationship of Serum Zinc Level With Severity of Diabetic Nephropathy

Zinc influences the production and action of erythropoietin (EPO), a hormone produced by the kidneys that stimulates red blood cell production. However, further research is needed to fully understand the mechanisms and to develop evidence-based guidelines for zinc supplementation in patient with Diabetic kidney disease. this study aim to detect serum zinc level in patient with Diabetic kidney disease "CKD" and Study of association between serum zinc and serum urea, creatinine, GFR, hemoglobin ,HbA1c in DKD

Clinical Utility of a Genomic Predictor Test on the Management of Cardiorenal Complications of Type 2 Diabetes

The goal of this pragmatic trial is to provide Real World Evidence (RWE) on the impact of the result of a polygenic risk prediction test of cardiorenal complications of T2D, so that more patients at high risk of these complications achieve over an 18 months period, recommended therapeutic targets. This will be demonstrated as a significant improvement in a composite value including HbA1c or systolic blood pressure (SBP) or albuminuria (UACR), or glomerular filtration rate (GFR) lowering. Researchers will compare the recommended therapeutic targets of uninformed and informed patients to see if the knowledge of the risk by the patients and their treating physicians improves achievement of these targets. Participants will: Have a saliva sampling to determine the genetic risk. Visit the clinic once every 3 months for checkups and tests Answer two questionnaires on quality of life.

Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.

The main purpose of this study is to explore the improvement of renal function before and after the intervention of dorzagliatin in patients with type 2 diabetes.

Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic Nephropathy

This is a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of low-dose aspirin (50 mg/day) in renal and cardiac function protection in people with diabetic nephropathy.

Multidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy

Diabetes nephropathy (DN) is one of the most serious microvascular complications of diabetes, and also an important cause of death and disability of diabetes patients. There is no specific clinical staging of type 2 diabetes nephropathy at home and abroad, and there is no comprehensive study to comprehensively describe the occurrence and development of type 2 diabetes nephropathy through sensitive biomarkers, microvascular disease imaging and functional detection, digital markers and other multi-dimensional diagnosis and evaluation methods. Therefore, our research aims to establish a long-term follow-up queue for the whole cycle of diabetes nephropathy, develop multi-dimensional diagnostic and progress digital markers for diabetes nephropathy, develop a multimodal non-invasive diagnostic model and a new clinical staging/typing, and create a multi-dimensional accurate diagnosis and treatment system for type 2 diabetes nephropathy combining traditional Chinese and western medicine.

Screening and Application Research of Early Diabetic Nephropathy Markers Based on Lipidomics.

Diabetic nephropathy (DN) is one of the major microvascular complications associated with diabetic patients, and also the major global cause of chronic kidney disease and end-stage renal disease (ESRD). Albuminuria and estimated glomerular filtration rate (eGFR) are currently recognized clinical indicators for early diagnosis of DN, however, the sensitivity and specificity are unsatisfactory. The early identification and treatment of DKD are conducive to lowering the risk of kidney damage by as much as 50%. Therefore, it is particularly critical to find new biomarkers to reflect the potential DKD lesions in the clinical silent period earlier and more accurately. Therefore, this study intends to analyze the differentially expressed lipids in early DKD, T2DM and healthy adults by mass spectrometry, and verify the related results by larger samples, so as to screen out early markers of DKD and achieve the ultimate goal of clinical application.