Diabetic Kidney Disease

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Diabetic Kidney Disease

General Purpose:

Kidney disease develops gradually over many years. Over time, individuals who are developing kidney disease begin to accumulate tiny amounts of the blood protein known as albumin in their urine. This is the first stage of chronic kidney disease, or CKD, and is known as microalbuminuria.

As Chronic Kidney Disease, or CKD progresses, the amount of albumin that leaks into the urine increases, resulting in a condition known as macroalbuminuria or proteinuria. At the same time, the kidneys begin to lose their ability to filter the blood, causing the body to retain waste that should have been cleared by the kidneys. Blood pressure can also rise as this is happening.

Kidney failure results when the kidneys completely lose their ability to clear waste from the body. Kidney failure is the final stage of CKD, and diabetes is the leading cause of kidney failure, accounting for nearly half of all new cases.

Fortunately, most individuals with diabetes do not develop kidney failure; nevertheless, approximately 180,000 people are currently living with kidney failure as a result of their diabetes. Unfortunately, once kidney failure has begun, the only two options available are dialysis or a kidney transplant.

Researchers have made great strides in their efforts to develop ways to slow the development and progression of CKD in diabetic individuals. A number of medications have been developed for such purposes, and new ones are constantly being tested through clinical trials.

Dietary and glucose-management strategies are also helpful at managing CKD, and researchers continue to investigate these and other methods of managing the symptoms associated with CKD.

Studies are also attempting to gain a better understanding of the relationship between diabetes and CKD in an effort to predict which patients will develop kidney disease, and in turn, develop more effective treatment strategies.

What Will A Diabetic Kidney Disease Clinical Trial Be Like?

The types of tests and assessments used in diabetic kidney disease clinical trials will ultimately depend on the specific nature of the study and what aspects of diabetic kidney disease are being investigated. Provided below is a list of frequent procedures and tests that may be incorporated for use in clinical trials:

  • Physical exam
  • Glycated hemoglobin test (A1C test): a blood test that indicates an individual’s average blood sugar level over the prior two months.
  • Random, standard blood sugar tests that measure the amount of glucose in the blood at a particular point in time.
  • Fasting blood sugar tests that measure blood sugar levels following an overnight fast.
  • Oral glucose tolerance tests: this test involves overnight fasting, followed by a fasting blood sugar test, then consumption of a sugary liquid. Blood sugar levels are then tested periodically over the following few hours.
  • Blood sample to monitor the estimated glomerular filtration rate (eGFR), which is a blood marker used to measure how quickly and effectively the kidneys are filtering the blood. Kidney disease is considered to be present when eGFR is less than 60 milliliters per minute.
  • Urine test to measure the amount of albumin and creatinine. Kidney disease is considered to be present when urine contains more than 30 milligrams of albumin per each gram of creatinine present, regardless of the eGFR.
  • Blood pressure monitoring
  • Exercise and/or dietary interventions
  • Intensive glucose management
  • Dialysis or kidney transplantation
  • Blood tests to evaluate the effectiveness or chemical properties of a medication, if you are participating in a clinical trial that is investigating the use of a new drug.
  • Pain and quality of life assessments, as well as food and/or exercise diaries, may also be required in some studies, depending on the research question being studied.

Typical Diabetic Kidney Disease Clinical Trial Protocol:

Specific examples of clinical trials for diabetic kidney disease might include the following:

  • An observational study in which a newly-developed method of scanning for diabetic kidney disease is compared to standard methods of screening.
  • A randomized clinical trial in which subjects with diabetic kidney disease are randomly assigned to receive standard treatment plus a newly-developed vitamin-D derived drug, or standard treatment plus a placebo.
  • A randomized clinical trial in which individuals with diabetic kidney disease who are receiving standard treatment are randomly assigned to receive a behavioral intervention consisting of a low-protein diet, or no intervention. The purpose of such a study would be to determine if the addition of a low-protein diet to existing standard therapy for diabetic kidney disease would help to slow progression of kidney damage.
  • A long-term observational study to determine if children with diabetes who adhere to a long-term low-protein, low-carbohydrate diet and who take vitamin D supplements have a decreased risk of developing diabetic kidney disease when compared to diabetic children who receive no dietary interventions and consume no additional vitamin D.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo (such as the second example provided above). Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or treatment is being evaluated for the first time, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. I

t is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your history of diabetes, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you may want to have on hand include:

  • Your most recent A1C measurement
  • Your eGFR rate (if known)
  • Your most recent albumin and creatinine measurements (if known)
  • Your prior history of treatment for diabetes and other medical conditions (including any surgeries, procedures, and medications)
  • Your current medications (including aspirin), vitamins, and dietary supplements
  • Your most recent blood pressure, cholesterol, and triglyceride (i.e., lipid) levels (if known) 

Suggested Search Terms:

Once you are ready to begin your search for clinical trials, the following key words may be of use when combined with the phrase “diabetic kidney disease”: “pediatric,” “treatment,” “medication,” “surgery,” “prevention,” “diet,” “exercise,” “nutrition,” “complications,” “management,” “transplant,” and “dialysis.”

 

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“Diabetic Kidney Disease

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This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 5 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated


Condition:   Diabetic Nephropathies
Interventions:   Drug: BI 690517;   Drug: Eplerenone;   Drug: Placebo
Sponsor:   Boehringer Ingelheim
Not yet recruiting - verified May 2017


This Study Tests a New Medicine Called BI 685509 in Patients That Have Kidney Problems Because of Diabetes. The Study Tests How BI 685509 is Taken up in the Body and How Well it is Tolerated (Multiple Rising Doses)


Condition:   Diabetic Nephropathies
Interventions:   Drug: BI 685509;   Drug: Placebo
Sponsor:   Boehringer Ingelheim
Not yet recruiting - verified May 2017


Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan


Condition:   Type 2 Diabetic Nephropathy
Interventions:   Drug: Alfacalcidol;   Drug: Irbesartan
Sponsor:   The Third Xiangya Hospital of Central South University
Recruiting - verified May 2017


The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage


Condition:   Diabetic Kidney Disease
Interventions:   Drug: Tangshen Prescription;   Drug: Placebos
Sponsors:   Guang'anmen Hospital of China Academy of Chinese Medical Sciences;   Anhui Provincial Hospital of Traditional Chinese Medicine;   Zhengzhou City Hospital of Traditional Chinese Medicine;   Shijiazhuang City Hospital of Traditional Chinese Medicine;   Baoding City Hospital of Traditional Chinese Medicine;   Hubei Hospital of Traditional Chinese Medicine;   Changchun Hospital of Traditional Chinese Medicine;   Xingtai City Hospital of Traditional Chinese Medicine;   Medicine Zibo Wanjie Tumor Hospital;   Zouping Country Hospital of Traditional Chinese Medicine;   She Country Hospital of Traditional Chinese Medicine;   Beijing Hospital of TCM;   Baishi Hospital
Not yet recruiting - verified January 2017


Transformative Research in Diabetic Nephropathy


Conditions:   Diabetic Nephropathies;   Diabetic Glomerulosclerosis
Intervention:   Other: There is no intervention
Sponsors:   University of Pennsylvania;   Columbia University;   Mount Sinai Hospital, New York;   University of Michigan;   University of California, San Diego;   University of North Carolina;   University of Texas;   Case Western Reserve University;   Vanderbilt University;   University of Toronto;   Stanford University;   GlaxoSmithKline;   Boehringer Ingelheim;   Regeneron Pharmaceuticals;   University of Florida
Recruiting - verified December 2016


Resveratrol's Effects in Diabetic Nephropathy


Condition:   Diabetic Nephropathy
Interventions:   Drug: Resveratrol;   Drug: Placebo;   Drug: Losartan
Sponsor:   Shiraz University of Medical Sciences
Recruiting - verified October 2016


Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy


Conditions:   Diabetic Nephropathy;   Albuminuria
Interventions:   Drug: Pirfenidone;   Drug: Placebo
Sponsors:   Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran;   Grupo Medifarma, S. A. de C. V.
Recruiting - verified August 2016


An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy


Condition:   Diabetic Nephropathy
Interventions:   Drug: MT-3995 Low;   Drug: MT-3995 Middle;   Drug: MT-3995 High
Sponsor:   Mitsubishi Tanabe Pharma Corporation
Active, not recruiting - verified February 2017


Lipo-prostaglandin E1 Improves Renal Hypoxia Evaluated by BOLD-MRI in Patients With Diabetic Nephropathy


Condition:   Diabetic Nephropathy
Intervention:   Drug: Lipo-PGE1
Sponsor:   West China Hospital
Completed - verified November 2016


NEPHSTROM for Diabetic Kidney Disease


Condition:   Diabetic Kidney Disease
Interventions:   Biological: Mesenchymal Stromal Cells;   Other: Placebo
Sponsors:   Mario Negri Institute for Pharmacological Research;   Leiden University Medical Center;   ASST Papa Giovanni XXIII, Bergamo, Italy;   IRCCS - Istituto di Ricerche Farmacologiche Mario Negri - Bergamo, Italy;   Belfast Health and Social Care Trust;   National University of Ireland, Galway, Ireland;   University Hospital Birmingham, NHS Foundation Trust, Hospital, Birmingham, UK;   NHS Blood and Transplant
Not yet recruiting - verified May 2017


Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy


Condition:   Diabetic Nephropathy
Interventions:   Drug: MT-3995 Low;   Drug: MT-3995 Middle;   Drug: MT-3995 High;   Drug: Placebo
Sponsor:   Mitsubishi Tanabe Pharma Corporation
Completed - verified March 2017


Semi-individualised Chinese Medicine Treatment as an Adjuvant Management for Diabetic Nephropathy


Condition:   Diabetic Nephropathies
Interventions:   Drug: Semi-individualised Chinese Medicine treatment;   Drug: Routine medical care (active comparator)
Sponsors:   The University of Hong Kong;   School of Chinese Medicine, The University of Hong Kong
Recruiting - verified October 2016


Colchicine for Diabetic Nephropathy Trial


Condition:   Diabetic Nephropathies
Interventions:   Drug: Colchicine;   Drug: Placebo
Sponsors:   Sheba Medical Center;   D-Cure, Israel
Recruiting - verified May 2017


Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout


Condition:   Diabetic Nephropathy
Interventions:   Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks);   Drug: Placebo BID, (Oral daily dosing for 28 weeks)
Sponsors:   Sanwa Kagaku Kenkyusho Co., Ltd.;   Fuji Yakuhin Co., Ltd.
Completed - verified November 2015


Phase 2 Study to Evaluate Safety & Efficacy of VPI-2690B in Diabetic Nephropathy Patients


Condition:   Diabetic Nephropathy
Interventions:   Drug: VPI-2690B low dose;   Drug: VPI-2690B medium dose;   Drug: Placebo to match VPI-2690B;   Drug: VPI-2690B high dose
Sponsor:   Vascular Pharmaceuticals, Inc.
Completed - verified March 2017


Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease


Condition:   Diabetic Kidney Disease
Interventions:   Drug: Selonsertib;   Drug: Placebo to match selonsertib
Sponsor:   Gilead Sciences
Completed - verified January 2017


Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy


Conditions:   Diabetes Mellitus, Type 2;   Diabetic Nephropathy
Interventions:   Drug: Canagliflozin;   Drug: Placebo
Sponsors:   Janssen Research & Development, LLC;   The George Institute for Global Health, Australia
Recruiting - verified May 2017


To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy


Condition:   Diabetic Nephropathy
Interventions:   Drug: DW1029M 600mg;   Drug: DW1029M 1200mg;   Drug: Placebo
Sponsor:   Dong Wha Pharmaceutical Co. Ltd.
Completed - verified February 2017


Effect of Green Tea (Epigallocatechin Gallate) on Albuminuria in Patients With Diabetic Nephropathy.


Conditions:   Diabetic Nephropathy;   Hypertension
Intervention:   Drug: Green tea extract
Sponsor:   University of Campinas, Brazil
Completed - verified August 2013


Study Of Diabetic Nephropathy With Atrasentan


Condition:   Diabetic Nephropathy
Interventions:   Drug: Atrasentan;   Drug: Placebo
Sponsor:   AbbVie
Recruiting - verified April 2017


Safety and Efficacy of Mesenchymal Precursor Cells in Diabetic Nephropathy


Conditions:   Diabetic Nephropathy;   Type 2 Diabetes
Interventions:   Biological: Mesenchymal Precursor Cells (MPCs);   Biological: Mesenchymal Precursor Cells (MPCs)
Sponsor:   Mesoblast, Ltd.
Completed - verified October 2016


Efficacy and Safety Study of Probucol in Patients With Diabetic Nephropathy


Condition:   Diabetic Nephropathy
Interventions:   Drug: Probucol 250mg/day;   Drug: Probucol 500mg/day;   Drug: Placebo
Sponsor:   Korea Otsuka Pharmaceutical Co., Ltd.
Completed - verified May 2017


Acthar for Treatment of Proteinuria in Diabetic Nephropathy Patients


Condition:   Diabetic Nephropathy
Interventions:   Drug: Repository Corticotropin Injection;   Drug: Placebo
Sponsor:   Mallinckrodt
Completed - verified November 2016


Renal Denervation in Diabetic Nephropathy


Conditions:   Diabetic Nephropathy;   Persistent Proteinuria With Type II Diabetes
Interventions:   Procedure: Percutaneous renal denervation and TMNS;   Drug: Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin
Sponsor:   Assistance Publique - Hôpitaux de Paris
Completed - verified May 2016


Delaying the Progression of Diabetic Nephropathy in Pima Indians


Condition:   Diabetic Nephropathy
Intervention:  
Sponsor:   National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Completed - verified August 16, 2011

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