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).
Phase:
N/A
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)