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Tetracycline Antibiotic

Minocycline for Diabetic Kidney Disease

N/A
Waitlist Available
Led By Sharon G Adler, MD
Research Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study 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.

Eligible Conditions
  • Diabetic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 24 hour urine protein/creatinine ratio (average of 2 values) baseline compared to 6-months in placebo vs minocycline
Secondary outcome measures
Creatinine
Change in average MACR in 24 hour urine, daytime and overnight collections (baseline vs 6 mos)
Change in urine and blood biomarkers in minocycline vs placebo treated patients at baseline vs 6 mos
Other outcome measures
Safety

Side effects data

From 2017 Phase 2 trial • 22 Patients • NCT01746043
20%
Peripheral Neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Armodafinil+Minocycline
Minocycline
Armodafinil

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MinocyclineExperimental Treatment1 Intervention
Minocycline 100 mg po bid for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo one tablet po bid

Find a Location

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
101 Previous Clinical Trials
46,271 Total Patients Enrolled
Sharon G Adler, MDPrincipal InvestigatorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Frequently Asked Questions

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~2 spots leftby Apr 2025