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Colchicine for Diabetic Nephropathy Trial (CDNT)

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ClinicalTrials.gov Identifier: NCT02442921
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
D-Cure, Israel
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
Forty patients with diabetic nephropathy will be treated with colchicine up to 2 mg, or placebo, for 18 months. A follow up will be performed after 12 additional months. The primary outcome will be a significant reduction or stabilization of proteinuria during the 18 month treatment period.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathies Drug: Colchicine Drug: Placebo Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Colchicine Treatment on the Progression of Proteinuria in Patients With Diabetic Nephropathy.
Actual Study Start Date : February 22, 2016
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Colchicine
20 patients will receive up to 2 mg of colchicine for 18 months
Drug: Colchicine
up to 2mg of Colchicine daily

Placebo Comparator: Placebo
20 patients will receive placebo for 18 months
Drug: Placebo
Daily placebo




Primary Outcome Measures :
  1. Change of urinary protein excretion ( mg/24hrs) from baseline to 18 months. [ Time Frame: From baseline to 18 months ( end of trial ) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with diabetes mellitus , age>18 years old, able to sign an informed consent.
  2. Hemoglobin A1c in the range of 6-9%, stable for last year (0.5±)
  3. Blood creatinine lower than 2 mg/dL.
  4. Blood pressure lower than 140/90 mmHg on stable anti-hypertensive treatment for at least 3 months.
  5. Treated with ACE or angiotensin II receptor blocker , unless contraindicated

Exclusion Criteria:

  1. Malignancy or significant heart, lung or liver disease.
  2. Any GI disease, inflammatory bowel disease , malnutrition ( BMI under 18 )
  3. Psychiatric disease
  4. Any muscle disease, history of rhabdomyolysis , myopathy or myositis.
  5. Any disease causing renal injury/proteinuria apart from diabetes mellitus
  6. Any inflammatory or autoimmune disease
  7. Any infection during the last month.

Information from the National Library of Medicine

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): NCT02442921


Contacts
Contact: Shaye Kivity, MD 0526668143 kivitys@gmail.com
Contact: Naomi Friedman, Ms.c naomi.friedman@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Shaye Kivity, MD    0526668134    kivitys@gmail.com   
Contact: Naomi Friedman, M.sc    +972544451556    naomi.friedman@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
D-Cure, Israel
Investigators
Principal Investigator: Shaye Kivity, MD Sheba Medical Center

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02442921     History of Changes
Other Study ID Numbers: SHEBA-2015-1560-SK-CTIL
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents