Minocycline and Proteinuria in Diabetic Nephropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01779089|
Recruitment Status : Unknown
Verified May 2015 by Los Angeles Biomedical Research Institute.
Recruitment status was: Active, not recruiting
First Posted : January 30, 2013
Last Update Posted : May 21, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy||Drug: Minocycline 100 mg po bid for 6 months Drug: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Safety and Efficacy of Minocycline as an Anti-Proteinuric in Diabetic Nephropathy|
|Study Start Date :||February 2009|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
Minocycline 100 mg po bid for 6 months
Drug: Minocycline 100 mg po bid for 6 months
Minocycline 100 mg po bid or placebo for 6 months
Placebo Comparator: Placebo
Placebo one tablet po bid
- 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 [ Time Frame: 6 mos ]Track the development of positive ANA and ANCA in placebo and minocycline-treated patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779089
|United States, California|
|Los Angeles Biomedical Reaearch Institute at Harbor-UCLA Medical Center|
|Torrance, California, United States, 90509|
|Principal Investigator:||Sharon G Adler, MD||Los Angeles Biomedical Research Institute|