Minocycline and Proteinuria in Diabetic Nephropathy
Status:
Unknown status
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Diabetic kidney disease increases the risk of illness and death from heart disease in
patients with Type 2 diabetes. Some blood pressure medications called ACE inhibitors and ARBs
slow progression of kidney disease, but the dose that can be used is often limited by side
effects that are experienced by patients. The most limiting side effects of the current
treatments are lowering of the kidney function or blood pressure, and a rise in blood
potassium levels. A safe and inexpensive medication that doesn't lower kidney function or
blood pressure or raise serum potassium would be useful.
Minocycline is a tetracycline antibiotic with recently appreciated protective properties. In
a published journal article by Dr. Isermann, minocycline prevented the death of specialized
kidney cells in mice. The kidneys of these mice did not develop diabetic kidney disease when
seen under the microscope and the mice experienced only a little bit of protein loss in the
urine. In a different published paper, the authors showed that minocycline also decreased
kidney injury in a model of non-diabetic kidney disease. A related tetracycline antibiotic
was shown to lower urine protein in diabetic patients. These data support a rationale for
testing to see if minocycline is safe and helpful in patients with diabetic kidney disease.
In this study, all patients will stay on their usual medications for the treatment of
diabetic kidney disease. Patients will be given either minocycline (100 mg by mouth twice a
day for 24 weeks) or placebo (an inactive capsule taken twice a day for 24 weeks).
Minocycline or placebo will be assigned by a process called "randomization", which is like a
coin toss. Neither the patient nor the study team will know if the patient is taking placebo
or minocycline until the end of the study. The study will assess minocycline safety and test
to see if minocycline is helpful or not helpful for the treatment of diabetic kidney disease.
This study was funded by the American Diabetes Association and is not supported by any
pharmaceutical company.
Phase:
N/A
Details
Lead Sponsor:
Los Angeles Biomedical Research Institute Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center