Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065559
Status:
TERMINATED
Last Update Posted:
2010-01-14
First Post:
2003-07-28
Brief Title:
Treatment of Diabetic Nephropathy
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2010-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 subjects 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 subjects 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 13585mmHg
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
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 subjects 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 subjects 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 13585mmHg
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None