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Diabetic Nephropathies clinical trials

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NCT ID: NCT04929379 Recruiting - Clinical trials for Diabetic Nephropathies

A Pilot Study of Fenofibrate to Prevent Kidney Function Loss in Type 1 Diabetes

PERL-FENO
Start date: January 4, 2022
Phase: Phase 2
Study type: Interventional

Diabetic kidney disease remains the leading cause of end-stage kidney disease (ESKD), rising in frequency in parallel with the epidemic of diabetes worldwide. The estimated lifetime risk of kidney disease in persons with type 1 diabetes (T1D) has been reported to be as high as 50-70%, although risk may be lower in excellent care environments. Two previous studies have suggested that a generic drug used to lower fats in blood (fenofibrate) may protect the kidney from damage due to diabetes. These data, however, were obtained among people with type 2 diabetes with clinical characteristics optimized for cardiovascular studies. Thus, a clinical trial specifically designed to evaluate the effects on the kidney is required to firmly show that this drug can prevent kidney damage in T1D. The goals of the present pilot study are to demonstrate the feasibility of such trial, gather essential information for designing and planning this study, and generate preliminary data. To this end, 40 participants with T1D and early-to-moderate diabetic kidney disease (DKD), at high risk of ESKD, will be enrolled at two clinical sites and assigned in a 1:1 ratio to treatment with fenofibrate or placebo for 18 months. Kidney function will be measured at the beginning and at the end of the study to evaluate the effect of fenofibrate.

NCT ID: NCT04916132 Recruiting - Clinical trials for Chronic Kidney Diseases

Diabetic Nephropathy in People With Diabetes. Prevalence and Predictive Factors

PRIMETIME2
Start date: August 10, 2021
Phase:
Study type: Observational

a prospective, observational, multi-center study with a cohort of 300 patients with Type 2 diabetes and macroalbuminuria. Prospectively we will collect kidney biopsies and analyse the transciptome of the kidney tissue and other biomarkers from blood, faeces, urine, proteomic- and metabolomic profiles and DNA-variants. Thereby we hope to be able to discover molecular and clinical profiles, that can help us in the diagnosis of DKD, and to identify different risks of progression that can benefit from different forms of personalized treatment.

NCT ID: NCT04802395 Recruiting - Clinical trials for Chronic Kidney Diseases

Real World Evidence Clinical Utility Study of KidneyIntelX

Start date: March 2, 2021
Phase:
Study type: Observational

The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.

NCT ID: NCT04791358 Recruiting - Clinical trials for Diabetic Kidney Disease

Decision Impact Trial of KidneyIntelX

Start date: November 1, 2021
Phase:
Study type: Observational

The current trial is designed to evaluate how the results of KidneyIntelX test impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.

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: 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.

NCT ID: NCT04216849 Recruiting - Clinical trials for Type 2 Diabetes With Renal Manifestations

Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy

Start date: July 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.

NCT ID: NCT04143412 Recruiting - Clinical trials for Diabetic Nephropathy Type 2

Efficacy of ACE Inhibitors, MRAs and ACE Inhibitor/ MRA Combination

Start date: February 4, 2019
Phase: Phase 2
Study type: Interventional

The aim of our work is to compare the antiproteinuric efficacy of ACEI monotherapy, Selective MRA monotherapy and their combination in mildly hypertensive patients with type 2 diabetes mellitus and microalbuminuria