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Colchicine for Diabetic Nephropathy

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Prof.Avi Livneh, Sheba Medical Center

Study Description
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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

Study Design
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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
U.S. FDA Resources

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


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

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

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.
Contacts and Locations
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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): NCT01005121


Contacts
Contact: Shaye Kivity, MD 03-5302436 kivitys@gmail.com

Locations
Israel
Sheba medical center, Tel hashomer Recruiting
Ramat gan, Israel, 52621
Contact: Shaye Kivity, MD    03-5302436    kivitys@gmail.com   
Sub-Investigator: Shaye Kivity, MD         
Sponsors and Collaborators
Prof.Avi Livneh
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Prof.Avi Livneh, Dept Head, Sheba Medical Center
ClinicalTrials.gov 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:
Kidney Diseases
Diabetic Nephropathies
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