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Diabetic Nephropathies clinical trials

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NCT ID: NCT04705506 Completed - Clinical trials for Diabetic Nephropathies

Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification

Start date: February 5, 2017
Phase: N/A
Study type: Interventional

Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic actions on kidney injury, albuminuria and vascular inflammation especially in animal models. We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these aspects in diabetic nephropathy patients.

NCT ID: NCT04689074 Completed - Clinical trials for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Establishment of the Human Intestinal and Salivary Microbiota Biobank - Kidney Diseases

BIOMIS-Nefro
Start date: February 3, 2021
Phase:
Study type: Observational

This is a prospective, clinical, multicentre study aimed to collect biological samples and study microbiota from subjects suffering from chronic kidney disease and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological). The study will allow to: - Provide biological samples (faeces, saliva, blood, urine) from healthy volunteers and patients suffering from chronic renal diseases to the first Italian microbiota biobank; - Study microorganisms using different in vitro and in vivo techniques; - Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.

NCT ID: NCT04661917 Withdrawn - Clinical trials for Chronic Kidney Disease

A Trial to Learn More About How BAY2327949 Works and How Safe it is in Patients Whose Kidneys Are Damaged Due to High Blood Sugar Levels or High Blood Pressures, and With a Further Disease of the Heart or the Blood Vessels.

ASSESS-CKD
Start date: May 31, 2021
Phase: Phase 2
Study type: Interventional

In people with type 2 diabetes (T2D), the body makes insulin, but cannot use it well. This results in high blood sugar levels causing damage to the blood vessels inside the kidneys. High blood pressure is a common condition that can cause damage to the blood vessels and heart if it is untreated. High blood pressure is also known as hypertension. Patients with type 2 diabetes (T2D) or high blood pressure are at a higher risk of having chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. Over time, the function of the kidney declines more, and this can lead to the requirement for dialysis or kidney transplantation. Most people with CKD are also at risk of heart conditions, such as heart attack or stroke. In this trial, the researchers want to learn if BAY2327949 reduces the amount of protein in the participants' urine. Protein in the urine is one of the signs of CKD. The researchers will compare the effects of BAY2327949 to a placebo. A placebo looks like the study drug but does not have any medicine in it. BAY2327949 is assumed to increase the blood flow through the kidneys, which may slow down the worsening of the disease. The researchers will use a placebo to learn if the changes seen in the participants are due to BAY2327949 or if the results could be due to chance. This trial will include about 120 men and women over the age of 45 who have CKD. The participants will have T2D or high blood pressure, and a further disease of the heart or blood vessels. During the trial, the participants will take either BAY2327949 or a placebo once a day for 28 days. The participants will visit their trial site about 9 times during the trial, and need to provide urine samples to check the participants' CKD symptoms. At the visits, the doctors will ask them if they have any health problems. They will also take blood samples to perform laboratory assessments.

NCT ID: NCT04635670 Completed - Type 1 Diabetes Clinical Trials

Effects of Probiotics and Fibers on Albuminuria in Persons With Type 1 Diabetes

ProFOS
Start date: June 29, 2020
Phase: N/A
Study type: Interventional

The primary objective is to assess the impact of three months' treatment with pre-/probiotic mix on markers of nephropathy and other comorbidity related to diabetes. A double blinded, randomized, placebo-controlled crossover, single-centre study including 46 patients with type 1 diabetes and albuminuria. The treatment period is 2 x 12 weeks with 6 weeks washout. The primary outcome is to evaluate the effect of pre-/probiotic mix on albuminuria.

NCT ID: NCT04626323 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease

OBESE-DKD
Start date: May 25, 2021
Phase: Phase 2
Study type: Interventional

Proven therapy for DKD is primarily limited to RAAS blockers and SLGT2i. Weight reduction has the potential to become an additional and much needed treatment option. Of all the weight reduction strategies metabolic surgery is suited to be the most effective. Yet no study has of yet compared the effect of metabolic surgery against best medical treatment on the progression of DKD. This pilot trial is designed to be the first determine the efficacy of metabolic surgery in slowing progression of DKD as compared to best medical therapy. The study design will address all the major limitations previously documented, including the major dilemma of estimating versus measuring GFR. Of note, the study's design will allow its sample size to be adjusted upward using an adaptive design if necessary, to achieve statistical significance. It will also inform study design and sample size issues for all future studies in this field. The payoff of establishing metabolic surgery as a new and effective intervention to slow progression to ESRD would be great in terms of reducing patient suffering and societal costs. This will be an open-label, randomized trial involving sixty (60) patients with diabetic kidney disease (DKD) and obesity who will undergo Roux-en-Y gastric bypass (RYGB) in the intervention arm or receive best medical treatment (BMT) in the control arm. The aim of this prospective, open, randomized study is to evaluate the efficacy and safety of RYGB surgery versus best medical treatment on the progression of DKD in patients with type 2 diabetes and obesity.

NCT ID: NCT04612595 Recruiting - Clinical trials for Diabetic Kidney Disease

The Association Between sUCR and the Survival in Patients With DKD

Start date: August 1, 2018
Phase:
Study type: Observational

Research Objective: To evaluate the prognostic value of serum urea nitrogen to creatinine ratio (sUCR) in the progression of DKD. Research Design: This study was designed as a multicenter, retrospective cohort study. According to sex and CKD stage , patients are divided into four groups,then evaluate the prognostic value of mean sUCR and ΔsUCR (fluctuation of sUCR over time, meaning monthly rate of change) in the progression of DKD.

NCT ID: NCT04589351 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe

DiaKidZ
Start date: October 1, 2020
Phase: Phase 3
Study type: Interventional

In this study, we seek to explore the importance of fat accumulation in the kidneys in relation to diabetic kidney disease (DKD). To do this, we conduct an intervention trial in individuals with type 2 diabetes (T2D) and DKD where we investigate whether the inhibition of intestinal cholesterol absorption with ezetimibe affects albuminuria (a strong risk factor for diabetic complications) and kidney fat accumulation. At the same time and to confirm that kidney fat accumulation is, in fact, abnormal in T2D and DKD, we conduct a cross-sectional study in which we compare kidney fat accumulation in participants at baseline from the intervention trial with a group of individuals with T2D and no DKD and a group of healthy individuals.

NCT ID: NCT04573920 Active, not recruiting - Clinical trials for Diabetic Kidney Disease

Atrasentan in Patients With Proteinuric Glomerular Diseases

AFFINITY
Start date: February 1, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04570735 Recruiting - Clinical trials for Diabetic Nephropathies

MRI Biomarkers in Diabetic Kidney Disease

MR3T - DKD
Start date: October 7, 2020
Phase:
Study type: Observational

Diabetic kidney disease is one of the most severe and frequent complications of diabetes. Few preclinical markers are available apart from plasma creatinine and microalbuminuria. These markers are imperfect (some patients with advanced renal disease do not have an increase in markers) and late. Therefor there is an uncovered need to identify complementary biomarkers. Magnetic Resonance Spectroscopy (MRS) is a Magnetic Resonance Imaging (MRI) technique that allows the physiology and biochemistry of human body tissues to be studied in a non-invasive and non-irradiating manner.

NCT ID: NCT04562025 Recruiting - Clinical trials for Diabetic Nephropathy

Clinical Research of UC-MSCs in the Treatment of Diabetic Nephropathy

UC-MSCs
Start date: September 25, 2020
Phase: N/A
Study type: Interventional

Diabetic nephropathy (DN) is one of the most serious complications of diabetes and the leading cause of end-stage chronic kidney disease. DN is a refractory disease with low awareness, high incidence, and high disability. The incidence of DN can reach 30 to 40% after 20 years of diabetes, of which 5~10% of patients will progress to end-stage renal disease, and epidemiological surveys predict that by 2030, DN will become the seventh leading cause of death in the world. Currently, there are no effective drugs for treating DN. This clinical trial is to inspect the safety and efficiency of human umbilical cord mesenchymal stem cells (UC-MSCs) therapy for patients with DN.