- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02442921
Colchicine for Diabetic Nephropathy Trial (CDNT)
The Effect of Colchicine Treatment on the Progression of Proteinuria in Patients With Diabetic Nephropathy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diabetic nephropathy is the leading cause today for end stage renal failure in the western world. Multifactorial intervention in patients may slow the rate of albuminuria and renal injury; however several new drug trials have failed so far to significantly attenuate its progression. Several pathways are identified in the development of diabetic nephropathy, however, in recent years many researchers suspect that inflammatory pathways play central roles in the progression of diabetic neuropathy . There is compelling evidence that diabetes mellitus has an auto-inflammatory component with Nlrp3 inflammasome and interleukin -1 β activation. Colchicine is a relatively safe anti-inflammatory drug used to treat and reverse albuminuria in familial Mediterranean fever nephropathy, an auto-inflammatory disease. Data from one study demonstrated that colchicine diminished proteinuria and inflammation in experimental-diabetic animal models.
Working hypothesis and aims:
To assess whether colchicine reduces proteinuria in diabetic patients with diabetic neuropathy , despite maximal multi-factorial interventions (angiotensin-converting-enzyme inhibitors, tight glycemic and hypertensive control, lifestyle intervention, etc.).
Methods:
Forty patients with stable diabetes, and diabetic neuropathy with proteinuria of 0.5-6g/24 hours, despite standard treatment, will receive colchicine (n=20) or placebo (n=20) for 18 months. Urinary protein and creatinine clearance will be assessed three months before the study initiation, at baseline and every three months thereafter. Blood creatinine, complete blood count, creatine phosphokinase , liver function tests, fasting Glucose Test, HbA1c, and urine protein/creatinine ratio and diabetes mellitus treatment monitoring and follow-up will be performed every three months. Oral colchicine treatment will be initiated at 1mg per day, and increased gradually to 2 mg, if gastrointestinal or musculoskeletal disturbances are absent or tolerated. The participants will be called and evaluated a year after the end of treatment for all parameters mentioned. Statistical analysis will be performed by a statistician.
Expected results:
A significant reduction or stabilization of proteinuria during the 18 month treatment period, or at follow up at one year later.
Importance and Relevance to the call This study may define a new treatment for diabetic nephropathy.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Shaye Kivity, MD
- Phone Number: 0526668143
- Email: kivitys@gmail.com
Study Contact Backup
- Name: Naomi Friedman, Ms.c
- Email: naomi.friedman@sheba.health.gov.il
Study Locations
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-
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Ramat Gan, Israel, 52621
- Recruiting
- Sheba Medical Center
-
Contact:
- Shaye Kivity, MD
- Phone Number: 0526668134
- Email: kivitys@gmail.com
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Contact:
- Naomi Friedman, M.sc
- Phone Number: +972544451556
- Email: naomi.friedman@sheba.health.gov.il
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with diabetes mellitus , age>18 years old, able to sign an informed consent.
- Hemoglobin A1c in the range of 6-9%, stable for last year (0.5±)
- Blood creatinine lower than 2 mg/dL.
- Blood pressure lower than 140/90 mmHg on stable anti-hypertensive treatment for at least 3 months.
- Treated with ACE or angiotensin II receptor blocker , unless contraindicated
Exclusion Criteria:
- Malignancy or significant heart, lung or liver disease.
- Any GI disease, inflammatory bowel disease , malnutrition ( BMI under 18 )
- Psychiatric disease
- Any muscle disease, history of rhabdomyolysis , myopathy or myositis.
- Any disease causing renal injury/proteinuria apart from diabetes mellitus
- Any inflammatory or autoimmune disease
- Any infection during the last month.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Colchicine
20 patients will receive up to 2 mg of colchicine for 18 months
|
up to 2mg of Colchicine daily
|
Placebo Comparator: Placebo
20 patients will receive placebo for 18 months
|
Daily placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of urinary protein excretion ( mg/24hrs) from baseline to 18 months.
Time Frame: From baseline to 18 months ( end of trial )
|
From baseline to 18 months ( end of trial )
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shaye Kivity, MD, Sheba Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-2015-1560-SK-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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