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Colchicine for 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. Identifier: NCT01005121
Recruitment Status : Unknown
Verified January 2013 by Prof.Avi Livneh, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : October 30, 2009
Last Update Posted : January 4, 2013
Information provided by (Responsible Party):
Prof.Avi Livneh, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: colchicine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Colchicine for Diabetic Nephropathy
Study Start Date : December 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: colchicine
patients will receive 2 mg of colchicine daily
Drug: colchicine
2mg, per-os, once daily for six months

Primary Outcome Measures :
  1. 24 hr urine protein collection [ Time Frame: every 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with DM aging 18+, able to sign an informed consent.
  2. 24 hour protein collection between 0.5-6 mg during the last 6 months prior enrollment.
  3. Hemoglobin A1c in the range of 6-9%, stable for the last year (0.5±)
  4. Creatinine lower than 1.5 mg/dL.
  5. Blood pressure lower than 150/90 mmHg on stable anti-hypertensive treatment for at least 3 months.
  6. Treated with ACE & ARB, unless contraindicated

Exclusion criteria:

  1. Malignancy or significant heart, lung or liver disease.
  2. Any GI disease, IBD, malnutrition ( BMI under 18 )
  3. Psychiatric disease
  4. Any muscle disease, history of rhabdomyelysis, myopathy or myositis.
  5. Any disease causing renal injury/proteinuria apart from DM
  6. Any inflammatory or autoimmune disease
  7. Any infection during the last month.
  8. Use of potentially nephrotoxic drugs.
  9. Woman in child bearing age that do not use at least one contraceptive device.
  10. Pregnant or lactating woman.
  11. Participation in another study during the last 3 months.
  12. Alcohol or drug abusers
  13. Anyone whom the investigators conclude are not appropriate
  14. Any patient receiving steroids.
  15. Any patient with Colchicine allergy, or treated with the drug during the last two weeks.

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 identifier (NCT number): NCT01005121

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Contact: Shaye Kivity, MD 03-5302436

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Sheba medical center, Tel hashomer Recruiting
Ramat gan, Israel, 52621
Contact: Shaye Kivity, MD    03-5302436   
Sub-Investigator: Shaye Kivity, MD         
Sponsors and Collaborators
Prof.Avi Livneh

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Responsible Party: Prof.Avi Livneh, Dept Head, Sheba Medical Center Identifier: NCT01005121     History of Changes
Other Study ID Numbers: SHEBA-09-7369-AL-CTIL
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013

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