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Colchicine for Diabetic Nephropathy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Study NCT01005121   Information provided by Sheba Medical Center

First Received on October 29, 2009.   No Changes Posted

October 29, 2009
October 29, 2009
December 2009
December 2010   (final data collection date for primary outcome measure)
24 hr urine protein collection [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
 
 
 
 
 
Colchicine for Diabetic Nephropathy
Colchicine for Diabetic Nephropathy

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.

 
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetic Nephropathy
Drug: colchicine
2mg, per-os, once daily for six months
Experimental: colchicine
patients will receive 2 mg of colchicine daily
Intervention: Drug: colchicine
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12
 
December 2010   (final data collection date for primary outcome measure)

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 rhabdomyelitis, 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.
Both
18 Years to 90 Years
No
Contact: Shaye Kivity, MD 03-5302436 kivitys@gmail.com
Israel
 
NCT01005121
SHEBA-09-7369-AL-CTIL
No
Prof Avi Livneh, Head of Internal medicine department F, Sheba medical center
Sheba Medical Center
 
 
Sheba Medical Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP