|
Treatment of Diabetic Nephropathy Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Treatment of Diabetic Nephropathy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Treatment of Diabetic Nephropathy Clinical research trials and Treatment of Diabetic Nephropathy medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Treatment of Diabetic Nephropathy. Treatment of Diabetic Nephropathy Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Treatment of Diabetic Nephropathy clinical trial. Participants oftentimes recieve the finest healthcare available for their Treatment of Diabetic Nephropathy condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Treatment of Diabetic Nephropathy  Treatment of Diabetic Nephropathy
Treatment of Diabetic Nephropathy
For Condition: Diabetic Nephropathy
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: COX-2 is an enzyme that is found in several different tissues in the body. COX-2 appears to produce a substance called prostaglandins, mainly at sites of inflammation. Several drugs have been approved by the FDA that inhibit COX-2 such as celecoxib, or brand name Celebrex®. These drugs are primarily used in patients with osteoarthritis and rheumatoid arthritis to decrease inflammation and pain. COX-2 inhibitors have been developed because they are more selective in treatment of inflammation and pain and tend to have fewer gastrointestinal side effects than NSAIDs (nonsteroidal anti-inflammatory drugs) such as aspirin, ibuprofen, naproxen, etc. The normal adult kidney expresses COX-2 in various regions. Prostaglandins, which are produced in the kidney by COX-2, may contribute to glomerular and tubulointerstitial inflammatory diseases (types of kidney diseases due to inflammation). In some animal studies, COX-2 inhibitors have been shown to be potentially beneficial in reducing the amount of protein spilled in the urine and preserving kidney function with these inflammatory kidney diseases. This study will compare the effects of COX-2 inhibitor to placebo (an inactive substance) in patients with diabetic nephropathy (kidney disease due to diabetes) and proteinuria (spilling protein in the urine) on 24-hour urinary protein excretion. This study is designed to see whether COX-2 inhibitors are useful in treating diabetic patients with kidney disease. The purpose of this study is a short-term pilot study that will allow the gathering of important data such as the ability to carry out the study and carry it out safely. Subjects with proteinuria and diabetic kidney disease already on ACE (Angiotensin-Converting Enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) therapy (types of blood pressure medicines) will be randomized to a type of study in which each subject will serve as their own control. The study is set up so that each subject will receive either the COX-2 inhibitor or placebo for a period followed by a period of no drug and then followed by a period of receiving either the COX-2 inhibitor or placebo (whichever they did not receive the first period).
Details: The study is designed with a screening period, a baseline period and a treatment period. The purpose of screening is to identify eligible subjects and to exclude ineligible subjects. A careful history and physical examination will be conducted to ensure that the subject meets all the inclusion criteria and does not meet any of the exclusion criteria. The screening period lasts from 2 days to 2 months in duration. The baseline period is from 2 – 3 months in duration. During the first baseline visit, there is withdrawal of previously used angiotensin converting enzyme inhibitors or angiotensin receptor antagonists (if any) and the initiation of quinapril 20 mg daily therapy (or irbesartan --150 - 300 mg daily). The subject will then be seen as frequently as determined by the investigator for subject’s safety. The purpose of the second baseline visit is to determine safety after the initiation of therapy quinapril 20 mg po per day (or irbesartan 150 - 300 mg per day). The purpose of third baseline visit is to insure that the subject meets all the inclusion and none of the exclusion criteria prior to randomization. In addition, it will be assured that the subject’s blood pressure is at a safe level to proceed with randomization and the laboratory and urinary collections will be made. Only those subjects who fulfill all inclusion and none of the exclusion criteria will proceed to randomization. Also, in order to proceed to the randomization phase of the study, the subject must have a blood pressure of less than or equal to 135/85mmHg. The treatment phase will consist of 18 weeks. During the treatment phase, the subject will be followed for safety and efficacy. The subjects will be randomly assigned to COX-2 inhibitor for 6 weeks (1st 6 week cycle), washout 3 weeks, placebo 6 weeks (2nd 6 week cycle), washout 3 weeks or to placebo 6 weeks (1st 6 week cycle), washout 3 weeks, COX-2 inhibitor 6 weeks (2nd 6 week cycle), washout 3 weeks. During baseline and treatment periods, interim visits will be held in order to address blood pressure control or other problems that the patient or the PI deems necessary for protocol adherence.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Age 18 years or greater - Men or non-pregnant, non-lactating women with Type 1 or Type II diabetes and renal disease - 24-hour urinary protein excretion greater than or equal to 500 mg - Serum creatinine less than or equal to 3 mg/dl - Willingness and ability to give informed consent and to cooperate with the protocol including discontinuing current antihypertensive medications if necessary Exclusion Criteria: - Pregnant or lactating women - Renal disease other than diabetic nephropathy - Renal Transplant or on dialysis - Immunosuppressive agents for greater than 2 weeks in the 3 months prior to randomization (inhaled steroids are permissible) - Renal vascular disease (uncorrected and hemodynamically significant) - Obstructive uropathy (uncorrected and hemodynamically significant) - History or evidence of acute renal failure within 6 months prior to randomization visit - Serum potassium greater than 5.2 mEq/L - Known human immunodeficiency virus disease (HIV) - Any major disorder which in the opinion of the investigator would reduce life expectancy during the course of this study or could preclude participation in this or could adversely effect the interpretation of the data. - Anticipated inability to cooperate with or any condition of sufficient severity to impair participation in the study. - Any of the following cardiovascular conditions within 1 month of the screening visit: myocardial infarction, coronary angioplasty, coronary artery bypass graft, other revascularization procedure, severe or unstable angina, stroke, transient ischemic attack or hemodynamically important vascular disease. - Need for chronic (greater than 2 weeks) immunosuppressive therapy including oral or IV corticosteroids. (Inhaled steroids are permissible.) - History of drug sensitivity or adverse reaction to both ACE I and ARB. - History of drug sensitivity, allergy, or adverse reaction to COX-2 inhibitor, aspirin, or sulfonamides. - Evidence or suspicion of drug abuse or excessive alcohol consumption within 12 months prior to screening visit 1. - Receipt of any investigational drug within 30 days or 5 half-lives of the investigational drug (the longer period will apply) before screening visit 1. - Active psychiatric disorder. - History of peptic ulcer disease and/or gastrointestinal bleeding.
Total Enrollment: 30
Location and Contact Information:
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee, 37232
United States
Recruiting Sandra McLeroy 615-936-1179
Duke University Medical Center *Not yet recruiting*
Durham, North Carolina, 27710
United States
Not yet recruiting John Middleton 919-660-6860
Rush Presbyterian St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Richard Rohde 312-942-6087
Additional Information:
Study ID Numbers: TRMTDN;
Study Start Date: April 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065559
Other Diabetic Nephropathy Studies:
1. Treatment of Diabetic Nephropathy
2. Matrix metalloproteinases and Diabetic Nephropathy
3. Pirfenidone: A New Drug to Treat Kidney Disease in Patients with Diabetes
4. The effect of LY333531 on protein in the urine in patients with type 2 diabetes.
5. Study of Drugs for High Blood Pressure and High Cholesterol in American Indians with Type 2 Diabetes at High Risk of Kidney or Heart Disease
Related Studies:
Other Diabetic Nephropathy Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Treatment of Diabetic Nephropathy
|
|
|
|
|
|
|
|
