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Diabetic Nephropathies clinical trials

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NCT ID: NCT04661917 Withdrawn - Clinical trials for Chronic Kidney Disease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NCT ID: NCT03504566 Withdrawn - Clinical trials for Diabetic Nephropathy Type 2

Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation (ROTATE-2)

ROTATE-2
Start date: November 15, 2017
Phase: Phase 4
Study type: Interventional

This project is an intervention study where type 2 diabetic patients will rotate through 4 different albuminuria lowering drugs with the aim to 1) quantify the individual relationship between drug exposure and albumin lowering response of different albuminuria lowering drugs in type 1 and type 2 diabetics; and 2) to investigate the effect of the same drug intervention on the glycocalyx layer in blood vessels. The overall purpose of this study is to allow for future personalized treatment of diabetics with regards to treating kidney disease more effectively than current standardized strategies.

NCT ID: NCT03173963 Withdrawn - Clinical trials for Diabetes Mellitus Type 2

Empaglifozin in Early Diabetic Kidney Disease

Start date: May 27, 2017
Phase: Phase 3
Study type: Interventional

Background: Diabetes is common among American Indian people and diabetic kidney disease is a common complication. Kidney disease caused by diabetes can lead to the need for kidney replacement, by dialysis or kidney transplant, and is also associated with higher risk of early death. A new diabetes medicine called empagliflozin may slow kidney disease from type 2 diabetes. Researchers want to learn if it protects the kidneys when used in very early stages of diabetic kidney disease. Objectives: To see if empaglifozin delays kidney disease development. Eligibility: Adults 18-64 years old who are at least half American Indian and have had type 2 diabetes at least 5 years Design: Participants will be screened with health questions, blood pressure, and blood and urine tests. Participants will have: - Medical history - Physical exam - Blood, urine, and stool samples taken - Scan of the kidneys and liver. Participants will lie on a table that slides into an MRI machine. They will hold their breath for up to 20 seconds and the MRI machine will take images of their kidneys and liver. They will then repeat this with a small device that vibrates on their side. - Kidney tests. A needle will be placed in a vein in each arm for 4 hours. Blood pressure will be taken. Participants will drink several quarts of water and urinate every 20 minutes. Urine and blood samples will be collected. Two liquids will be injected into their veins to measure kidney function. - Photos of the back of the eyes - Kidney biopsy. Participants will have a scan and get drugs to make them sleepy. Up to four very small pieces of kidney will be removed by needle. After the biopsy participants will be monitored for at least 4 hours. - Nerve tests Participants will take the study drug or placebo pill once a day. Participants will attend for tests every twelve weeks and have more extensive kidney function tests once a year. After 3 years, participants will have another kidney biopsy and then stop taking the study drug. They will have a final kidney function test 2 months later.

NCT ID: NCT03105219 Withdrawn - Clinical trials for Diabetic Kidney Disease

IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease

BENCH
Start date: July 1, 2017
Phase: Phase 3
Study type: Interventional

To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.

NCT ID: NCT02410499 Withdrawn - Clinical trials for Diabetic Nephropathy

Efficacy and Safety of Weekly Subcutaneous MLN1202 in Improving Diabetic Nephropathy in Participants With Macroalbuminuria

Start date: May 20, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the effects of 85 days treatment with MLN1202 on urinary albumin-to-creatinine ratio (UACR) in participants with type 2 diabetes, advanced kidney disease/diabetic nephropathy (DN) and macro-albuminuria (UACR>300 mg/g) based on average of 3 consecutive first morning voids sample collection.

NCT ID: NCT02011178 Withdrawn - Clinical trials for Diabetic Kidney Disease

Prevention of Microvascular Complications in Overweight Diabetics With Surgery or Best Medicine

PROMISE
Start date: March 2014
Phase: N/A
Study type: Interventional

Background: Diabetic kidney disease (DKD) is chronic and often progresses to kidney failure,heart disease and premature death. Unfortunately, the best medical therapies available for DKD today are ultimately unable to prevent its progression, especially in obese patients.Surgical rerouting of food within the gut with a gastric bypass operation (RYGB), improves diabetes and some of its complications. The investigators propose to investigate whether RYGB in combination with best medical therapy in patients with DKD and obesity prevent further deterioration of kidney function over a 3 years follow up period. Study design: This is an international collaboration with leading centres in Sweden and Switzerland in which100 obese type 2 diabetic patients with established DKD will volunteer to be randomly assigned to receive best medical therapy with RYGB or best medical therapy without surgery. Participants will be 18-65 years with type 2 diabetes and impaired kidney function. Yearly measurements of kidney function will then be done over a period of 3 years as a primary outcome to determine whether differences in DKD can be detectable. The study will also examine and compare a) safety of the interventions, b) the health economic impact on direct healthcare costs and Quality of Life in patients as well as c) the value of a new marker of DKD in determining which patients are most likely to benefit from surgery. Overall the study will strengthen the evidence base guiding clinical decisions about the usefulness of RYGB as an add on therapy to best medical therapy in stopping progressive DKD in patients with obesity and diabetes.

NCT ID: NCT01307917 Withdrawn - Clinical trials for Endothelial Dysfunction

Flavonoids in the Treatment of Endothelial Dysfunction in Children With Diabetes

flavonoid
Start date: July 2009
Phase: N/A
Study type: Interventional

Diabetes is the most common metabolic disease of childhood. Vascular disease is a leading complication of diabetes, and attempts to maintain close glycemic control do not prevent the sequelae that claim the lives and quality of life of millions of diabetics each year. Up to forty percent of patients with diabetes mellitus ultimately develop diabetic nephropathy, the most common cause of end-stage renal disease requiring dialysis in the US. Flavonoid-rich diets are a promising intervention to prevent the endothelial dysfunction that apparently leads to this deadly complication. The mechanisms are still unclear but probably involve nitric oxide synthesis. The investigators hypothesize that early maintenance of the integrity of renal vasculature will significantly improve the lifelong prognosis for patients with diabetes. Flavonoids with anti-inflammatory and antioxidant activities could be used to protect endothelial function, and together with good glycemic control, prevent the development and progression of nephropathy. The investigators aims are to: 1. compare endothelial function by studying reactive hyperemia, nitric oxide, and proinflammatory factors in adolescents (12-21 years old) with diabetes versus healthy sex- and age-matched control subjects. 2. identify early markers in urine for vascular endothelial injury. 3. examine the effects of flavonoids on vascular function, urine nitric oxide, and proinflammatory factors in patients with diabetes mellitus.

NCT ID: NCT00713011 Withdrawn - Hypertension Clinical Trials

Adalat XL vs Diltiazem on Proteinuria and Blood Pressure in Hypertensive Diabetic Patients

CARDINAL
Start date: November 2008
Phase: Phase 3
Study type: Interventional

The study consists of a 12 week run-in period when all subjects are stabilized on a single dose of Avalide (300 mg/12.5 mg or 300mg/25mg dose) per day. After this 12 week run-in ends, subjects will be randomly assigned to start the addition of either Adalat XL or Tiazac XC for 18 weeks of treatment. Subjects will have a 1 in 2 chance of receiving the study drug Adalat XL and a 1 in 2 chance of receiving the drug Tiazac XC. An end of treatment visit will be done 18 weeks after start of study drug. The expected duration of the study is 30 weeks. The purpose of this study is to compare the change in proteinuria, through a urine test, while taking study drug until high blood pressure (BP) is reduced to near normal levels in study subjects with diabetic nephropathy and hypertension.