Diabetic NephropathyNCT01779089
Minocycline and Proteinuria in Diabetic Nephropathy
A study testing Minocycline 100 mg po bid for 6 months in people with Diabetic Nephropathy, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Minocycline 100 mg po bid for 6 months
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of diabetes and diabetic nephropathy as described in the Family Investigation of Nephropathy and Diabetes Protocol
- Baseline creatinine clearance > 30 mL/min/1.73 m2 (at first screening visit)
- Proteinuria ≥ 1.0 g/day (at first screening visit)
- Age ≥30 years
- BP at baseline <150/95 mm Hg (measured sitting after 10 min rest at first screening visit)
- Adequate hepatic function defined as total bilirubin < 1.5 x the upper limit of the normal range (ULN), AST (SGOT) and ALT (SGPT) < 2.5 x ULN.
Show all 24Show fewer
- Patients taking ACEi, angiotensin receptor blockers (ARBs), aliskerin, spironolactone and/or diltiazem may be entered, but dosing may not change during the period of study or within 1 month prior to the first of the baseline proteinuria measurements.
- Exclusion Criteria:• NSAID (including COX-2 inhibitors) use > 3 tabs/week habitually
- Diagnosis of neurodegenerative diseases (Parkinson's disease, Huntington's disease, multiple sclerosis, Alzheimer's disease, etc).
- Any unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
- History of liver disease (screening AST > 3 times the upper limit of normal)
- History of hematologic disease (screening white blood cell count less than 3,800/mm3)
- History of systemic vasculitis or systemic lupus erythematosus
- Treatment with procainamide or hydralazine
- History of vestibular disease (excluding benign position vertigo)
- Pregnancy or lactation
- Allergy to tetracycline antibiotics
- Use of minocycline within thirty days of baseline visit
- Use of anti-epileptic medications other than gabapentin
- Use of lithium, digoxin, warfarin, other anticoagulants, and theophylline
- Limited mental capacity rendering the subject unable to provide written informed consent or comply with evaluation procedures
- History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols
- Use of any investigational drug within 30 days prior to the baseline visit
- Women with the potential to become pregnant who are not willing to practice double-barrier birth control
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Biomedical Reaearch Institute at Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: The Safety and Efficacy of Minocycline as an Anti-Proteinuric in Diabetic Nephropathy
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.
- Conditions
- Diabetic Nephropathy
- Being tested
- Minocycline 100 mg po bid for 6 months, placebo
- Keywords
- diabetic nephropathy, diabetic kidney disease, minocycline, proteinuria, albuminuria
- Medical subject headings
- Diabetic Nephropathies, cyclopia sequence, Proteinuria, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline 100 mg po bid for 6 monthsDrug
Minocycline 100 mg po bid or placebo for 6 months
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Minocycline 100 mg po bid for 6 months Receives: Drug: Minocycline 100 mg po bid for 6 months |
| Placebo | Placebo comparator | Placebo one tablet po bid Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24 hour urine protein/creatinine ratio (average of 2 values) baseline compared to 6-months in placebo vs minocycline
Measured: 6 months
Secondary outcomes (3)
Change in average MACR in 24 hour urine, daytime and overnight collections (baseline vs 6 mos)
Measured: 6 months
Change in average 24 hour urine protein/creatinine in daytime vs overnight collections, baseline vs 6 mos
Measured: 6 mos
Change in urine and blood biomarkers in minocycline vs placebo treated patients at baseline vs 6 mos
Measured: 6 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startFeb 2009
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon G Adler, MD, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779089
- Sponsor's protocol ID
- 013400
- Status last verified
- May 2015
- First submitted
- 28 Jan 2013
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shah AP, Shen JI, Wang Y, Tong L, Pak Y, Andalibi A, LaPage JA, Adler SG. Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial. PLoS One. 2016 Mar 28;11(3):e0152357. doi: 10.1371/journal.pone.0152357. eCollection 2016.
PubMed 27019421
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Minocycline as an Anti-Proteinuric in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01779089
- Acronym / sponsor ID
- 013400
- Conditions
- Diabetic Nephropathy
- Keywords
- diabetic nephropathy, diabetic kidney disease, minocycline, proteinuria, albuminuria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: Minocycline 100 mg po bid for 6 monthsMinocycline 100 mg po bid for 6 months |
| Placebo | Placebo comparator | Drug: placeboPlacebo one tablet po bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Clinical diagnosis of diabetes and diabetic nephropathy as described in the Family Investigation of Nephropathy and Diabetes Protocol
- Baseline creatinine clearance > 30 mL/min/1.73 m2 (at first screening visit)
- Proteinuria ≥ 1.0 g/day (at first screening visit)
- Age ≥30 years
- BP at baseline <150/95 mm Hg (measured sitting after 10 min rest at first screening visit)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline 100 mg po bid for 6 monthsMinocycline 100 mg po bid or placebo for 6 months | Drug | Minocycline |
| placebo | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Derived from this study: PubMed 27019421Shah AP, Shen JI, Wang Y, Tong L, Pak Y, Andalibi A, LaPage JA, Adler SG. Effects of Minocycline on Urine Albumin, Interleukin-6, and Osteoprotegerin in Patients with Diabetic Nephropathy: A Randomized Controlled Pilot Trial. PLoS One. 2016 Mar 28;11(3):e0152357. doi: 10.1371/journal.pone.0152357. eCollection 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon G Adler, MD principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minocycline 100 mg po bid for 6 months in people with Diabetic Nephropathy, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01779089, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.