An interventional study of Minocycline 100 mg po bid for 6 months and placebo in Diabetic Nephropathy, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-21.
Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Not applicable, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 30 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center is the lead sponsor of 67 studies on the registry; 1 is open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:• NSAID (including COX-2 inhibitors) use > 3 tabs/week habitually
Minocycline 100 mg po bid for 6 months
Drug: Minocycline 100 mg po bid for 6 months
Placebo one tablet po bid
Drug: placebo
Minocycline 100 mg po bid or placebo for 6 months
Change in 24 hour urine protein/creatinine ratio (average of 2 values) baseline compared to 6-months in placebo vs minocycline
Time frame: 6 months
Change in average MACR in 24 hour urine, daytime and overnight collections (baseline vs 6 mos)
Time frame: 6 months
Change in average 24 hour urine protein/creatinine in daytime vs overnight collections, baseline vs 6 mos
Time frame: 6 mos
Change in urine and blood biomarkers in minocycline vs placebo treated patients at baseline vs 6 mos
Time frame: 6 mos
Safety
Track the development of positive ANA and ANCA in placebo and minocycline-treated patients
Time frame: 6 mos
This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center