Colchicine for Diabetic Nephropathy
1 other identifier
interventional
12
1 country
1
Brief Summary
Patients with diabetic nephropathy and proteinuria, despite maximal anti- hypertensive and anti-glucose treatment, will receive colchicine for six months, 2 mg a day, during which their 24 hour urine protein and renal function tests will be monitored. The investigators' hypothesis is that colchicine will diminish proteinuria and might also help slow down the development of end stage renal failure in the long run.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
October 30, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 4, 2013
January 1, 2013
5 years
October 29, 2009
January 3, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
24 hr urine protein collection
every 2 months
Study Arms (1)
colchicine
EXPERIMENTALpatients will receive 2 mg of colchicine daily
Interventions
Eligibility Criteria
You may qualify if:
- Patients with DM aging 18+, able to sign an informed consent.
- hour protein collection between 0.5-6 mg during the last 6 months prior enrollment.
- Hemoglobin A1c in the range of 6-9%, stable for the last year (0.5±)
- Creatinine lower than 1.5 mg/dL.
- Blood pressure lower than 150/90 mmHg on stable anti-hypertensive treatment for at least 3 months.
- Treated with ACE \& ARB, unless contraindicated
You may not qualify if:
- Malignancy or significant heart, lung or liver disease.
- Any GI disease, IBD, malnutrition ( BMI under 18 )
- Psychiatric disease
- Any muscle disease, history of rhabdomyelysis, myopathy or myositis.
- Any disease causing renal injury/proteinuria apart from DM
- Any inflammatory or autoimmune disease
- Any infection during the last month.
- Use of potentially nephrotoxic drugs.
- Woman in child bearing age that do not use at least one contraceptive device.
- Pregnant or lactating woman.
- Participation in another study during the last 3 months.
- Alcohol or drug abusers
- Anyone whom the investigators conclude are not appropriate
- Any patient receiving steroids.
- Any patient with Colchicine allergy, or treated with the drug during the last two weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prof.Avi Livnehlead
Study Sites (1)
Sheba medical center, Tel hashomer
Ramat Gan, 52621, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dept Head
Study Record Dates
First Submitted
October 29, 2009
First Posted
October 30, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
January 4, 2013
Record last verified: 2013-01